Ravimiamet · structured requirements

🇪🇪 Estonia medical device regulatory data

Explore the medical device requirements currently available for Estonia, organized by topic and linked to official sources.

38 facts25 dimensions11 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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Medical device advertising in Estonia is governed by the general Advertising Act, and Ravimiamet supervises and prosecutes it

advertising.general-advertising-act-governs-medical-device-advertising

Fact-level verified

Estonia has no device-specific advertising statute; device advertising is governed by the general Advertising Act (Reklaamiseadus), and the Act expressly names medical devices in the bodies that supervise and prosecute it. Under § 30(2)(1), in addition to the general supervision of the Consumer Protection and Technical Regulatory Authority (Tarbijakaitse ja Tehnilise Järelevalve Amet, TTJA) under § 30(1), Ravimiamet supervises compliance with the requirements of Chapter 2 of the Act in respect of medical device advertising (and Chapter 2 plus § 18 in respect of medicinal product advertising); under § 36(2)(1) Ravimiamet is the extra-judicial body for the misdemeanours under §§ 33–35 in respect of violations of Chapter 2 in medical device advertising. The substantive general rules that therefore apply to a device advertisement are: it must be clearly distinguishable from other information under ordinary attention, and its content, design and manner of presentation must ensure that it is understood to be advertising, and it must clearly contain the name of the advertiser and its registered or applied-for Estonian or European Community trade mark or domain name (§ 3(1)–(2)); advertising that in any way misleads or is likely to mislead the persons to whom it is addressed or whom it reaches and which, by its misleading character, may affect their economic behaviour, or which for those reasons harms or may harm a competitor of the advertiser, is prohibited (§ 4(1)), and advertising is deemed misleading in particular where it gives misleading information about the availability, quantity, composition, usability, presence of accessories, technical data, the risks connected with use and storage including environmental safety, the manner and time of production, supply or provision, or the place of production or country of origin (§ 4(2)(1)); and advertising of technically complex goods, goods containing dangerous substances, or goods requiring special skill in use must contain a call to read the instructions for use and, where necessary, to consult a specialist, while advertising of goods intended for professional use only must contain information to that effect (§ 7(1), (3)).

Conditions

These provisions are framed on 'kaup' (goods), which § 2(1)(2) defines as a thing or right offered for sale, sold or otherwise marketed — a medical device is a good, so the general rules reach it without a device-specific rule.
Violation of the general advertising requirements is a misdemeanour under § 33 (fine up to 300 fine units for a natural person and up to EUR 400,000 for a legal person); § 36(2) names TTJA and, within their competence, the listed administrative bodies as extra-judicial bodies, Ravimiamet's competence for medical device advertising following from § 36(2)(1).
The Act's health-adjacent special regimes are separate and do not cover devices: § 22 (health service advertising) is supervised and prosecuted by Terviseamet, and the regime for medicinal products sits in the Ravimiseadus (Medicinal Products Act), with Ravimiamet's Advertising Act competence for medicinal products extending to § 18 as well as Chapter 2. The Advertising Act contains no medical device advertising section of its own — device advertising is reached through Chapter 2 and the supervision and enforcement assignment in §§ 30 and 36.
The Act's § 7(3) professional-use rule and § 7(1) instructions-for-use call are the closest thing in Estonian law to device-specific promotion content rules, and they apply to a device because it is a 'good' that may be technically complex, contain dangerous substances, require special skill in use, or be intended for professional use only.
The current wording of § 30(2)(1) and § 36(2)(1) was set by RT I, 20.11.2024, 1 (in force 01.01.2025); § 18 (advertising of narcotic and psychotropic substances) is part of Ravimiamet's remit only for medicinal product advertising, not for medical device advertising.

Language of source: Estonian. Verbatim § 30(2): "Lisaks käesoleva paragrahvi lõikes 1 sätestatule teostavad järelevalvet järgmiste haldusorganite ametiisikud vastavalt oma pädevusele: 1) Ravimiamet käesoleva seaduse 2. peatükis ning §-s 18 sätestatud nõuete järgimise üle meditsiiniseadme ja ravimi reklaami osas;" § 36(2): "Käesoleva seaduse §-des 33–35 sätestatud väärteo kohtuvälised menetlejad on Tarbijakaitseamet ja vastavalt oma pädevusele järgmised haldusorganid: 1) Ravimiamet käesoleva seaduse 2. peatükis ning §-s 18 sätestatud nõuete rikkumise korral meditsiiniseadme ja ravimi reklaami osas;" § 3(1): "Reklaam peab tavalise tähelepanu korral olema selgelt eristatav muust teabest ning selle sisu, kujundus ja esitlusviis peavad tagama arusaamise, et tegemist on reklaamiga." § 3(2): "Reklaamis peab selgelt eristatavalt sisalduma reklaami tellija nimi, tema registreerimisel olev või registreeritud Eesti või Euroopa Ühenduse kaubamärk või domeeninimi." § 4(1): "Reklaam, mis ükskõik millisel viisil eksitab või tõenäoliselt eksitab isikuid, kellele see on suunatud või kelleni see jõuab, ja mis oma eksitava iseloomu tõttu võib mõjutada nende isikute majanduskäitumist või nimetatud põhjustel kahjustab või võib kahjustada reklaami tellija konkurenti, on keelatud." § 4(2)(1): "kättesaadavus, kogus, koostis, kasutamiskõlblikkus, lisatarvikute olemasolu, tehnilised andmed, kasutamise ja hoidmisega seotud riskid, sealhulgas keskkonnaohutus, valmistamise, varumise või osutamise viis ja aeg, tootmispaik või päritolumaa;" § 7(1): "Tehniliselt keeruka, ohtlikke aineid sisaldava või kasutamisel erioskust nõudva kauba reklaam peab sisaldama üleskutset lugeda kasutusjuhendit ja vajaduse korral konsulteerida spetsialistiga." § 7(3): "Ainult professionaalseks kasutamiseks mõeldud kauba või teenuse reklaam peab sisaldama sellekohast teavet." English translation: § 30(2)(1) 'In addition to subsection 1 of this section, officials of the following administrative bodies carry out supervision according to their competence: 1) Ravimiamet over compliance with the requirements laid down in Chapter 2 and in § 18 of this Act in respect of advertising of medical devices and medicinal products;' § 36(2)(1) 'The extra-judicial bodies for the misdemeanour provided in §§ 33–35 of this Act are the Consumer Protection Board and, according to their competence, the following administrative bodies: 1) Ravimiamet in the case of violation of the requirements laid down in Chapter 2 and in § 18 of this Act in respect of advertising of medical devices and medicinal products;' § 3(1) 'Under ordinary attention, advertising must be clearly distinguishable from other information, and its content, design and manner of presentation must ensure the understanding that it is advertising.' § 3(2) 'Advertising must clearly and distinguishably contain the name of the advertiser and its registered or applied-for Estonian or European Union trade mark or domain name.' § 4(1) 'Advertising which in any way misleads or is likely to mislead the persons to whom it is addressed or whom it reaches, and which by its misleading character may influence the economic behaviour of those persons or for those reasons harms or may harm a competitor of the advertiser, is prohibited.' § 4(2)(1) 'availability, quantity, composition, usability, presence of accessories, technical data, the risks connected with use and storage, including environmental safety, the manner and time of production, supply or provision, the place of production or country of origin;' § 7(1) 'Advertising of goods that are technically complex, contain dangerous substances, or require special skill in use must contain a call to read the instructions for use and, where necessary, to consult a specialist.' § 7(3) 'Advertising of goods or services intended for professional use only must contain information to that effect.'

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Free sale certificate for export

validity.free-sale-certificate

Fact-level verified

On application, Ravimiamet issues a free sale certificate to a manufacturer or authorised representative registered in Estonia for the export of a medical device. The certificate attests that the registered place of business is in Estonia and that the CE-marked device may be marketed in the European Union. It is drawn up in English, issued in one copy on paper, and is valid for two years from issue unless the device's conformity certificate expires sooner.

Conditions

The certificate is for export outside the EEA and is not required for marketing within the EEA.
Its legal basis is MDR Article 60 or IVDR Article 55, together with § 32² of the Medical Devices Act.
A state fee is payable before the application is submitted (§ 32²(3)); the amount is set by § 285⁴ of the State Fees Act (Riigilõivuseadus), in force 1 January 2025 (EUR 154 within 45 days, EUR 308 within five working days, EUR 32 for a duplicate). The former § 298², which Ravimiamet's service page still cites, was repealed with effect from 1 January 2025.

Estonian source. Verbatim (1): "(1) Ravimiamet väljastab Eestis registreeritud tootjale või volitatud esindajale taotluse alusel meditsiiniseadme ekspordiks vabamüügi sertifikaadi, mis tõendab, et tootja või volitatud esindaja registreeritud tegevuskoht on Eesti Vabariigis ning CE-märgist kandvat asjaomast meditsiiniseadet võib Euroopa Liidus turustada." Verbatim (4): "(4) Vabamüügi sertifikaat kehtib kaks aastat alates väljastamisest, välja arvatud juhul, kui meditsiiniseadme vastavussertifikaadi kehtivusaeg on lühem."

Transitional validity of MDD/AIMDD certificates

validity.mdd-certificate-transitional-periods

Fact-level verified

Devices holding a valid Directive 90/385/EEC or 93/42/EEC certificate may continue to be placed on the market until 31 December 2027 for class III devices and class IIb implantable devices (with listed exceptions), and until 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. In Estonia these devices are also subject to the MDR requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices.

Conditions

The extended periods are conditional: the devices must still comply with the applicable directive, there must be no significant changes in design and intended purpose, they must not present an unacceptable risk, a QMS under MDR Article 10(9) had to be in place by 26 May 2024, and a notified body application had to be lodged by 26 May 2024 with a written agreement signed by 26 September 2024.
The transitional periods are Union law; they apply in Estonia because the Union regulations apply directly there.
As at 2026-09-15 the 2027 and 2028 end-dates are still in the future, so both periods remain live.

Effective from 2023-03-20

English source. Verbatim: "31 December 2027, for all class III devices, and for class IIb implantable devices except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors;" and "31 December 2028, for class IIb devices other than those covered by point (a) of this paragraph, for class IIa devices, and for class I devices placed on the market in sterile condition or having a measuring function." Verbatim (3d): "the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply to devices referred to in paragraphs 3a and 3b of this Article in place of the corresponding requirements in Directives 90/385/EEC or 93/42/EEC".

Authority & regime

Which authority and binding regime govern this product, task, and date?

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Competent authority for medical devices

authority.competent-authority-ravimiamet

Fact-level verified

Ravimiamet (State Agency of Medicines) performs the tasks and issues the administrative acts of the competent authority, and of the authority responsible for notified bodies, laid down in the Estonian Medical Devices Act and in Regulations (EU) 2017/745 and (EU) 2017/746, unless those regulations provide otherwise.

Conditions

Since 1 January 2025 the Medical Devices Act names Ravimiamet throughout; before that amendment the competent authority in most provisions was Terviseamet (Health Board).

Effective from 2025-01-01

Estonian source. Verbatim: "(1) Käesolevas seaduses ning Euroopa Parlamendi ja nõukogu määrustes (EL) 2017/745 ja (EL) 2017/746 sätestatud pädeva asutuse ja teavitatud asutuse eest vastutava asutuse toimingud teeb ja haldusaktid annab Ravimiamet, kui nimetatud määrustes ei ole sätestatud teisiti." The registry's display label "Ravimiamet" is correct; its English name is State Agency of Medicines.

Supervision split between Ravimiamet and Terviseamet

authority.supervision-split-ravimiamet-and-terviseamet

Fact-level verified

Ravimiamet carries out state and administrative supervision over compliance with the Medical Devices Act, the legislation established under it and Regulations (EU) 2017/745 and 2017/746; supervision of the requirements of Chapter 3 (professional use of devices in the provision of health services) is carried out by Terviseamet (Health Board).

Conditions

The split was introduced by the amendment published RT I, 20.11.2024, 1, in force 1 January 2025.

Effective from 2025-01-01

Estonian source. Verbatim (1): "Käesolevas seaduses ja selle alusel kehtestatud õigusaktides ning Euroopa Parlamendi ja nõukogu määrustes (EL) 2017/745 ja (EL) 2017/746 sätestatud nõuete täitmise üle teeb riiklikku ja haldusjärelevalvet Ravimiamet." Verbatim (2): "Käesoleva seaduse 3. peatükis sätestatud nõuete täitmise üle tervishoiuteenuse osutamisel teeb riiklikku ja haldusjärelevalvet Terviseamet."

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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No significant changes condition for transitional devices

change.no-significant-changes-condition-for-transition

Fact-level verified

A device may rely on the extended transitional periods of Regulation (EU) 2023/607 only if there are no significant changes in its design and intended purpose; a significant change in design or intended purpose moves the device out of the transitional regime and requires MDR conformity assessment.

Conditions

This condition sits alongside the other Article 120(3c) conditions (continued directive compliance, no unacceptable risk, QMS in place by 26 May 2024, notified body application and signed agreement by the 2024 deadlines).

Effective from 2023-03-20

English source. Verbatim: "(b) there are no significant changes in the design and intended purpose;".

Notification of significant changes to custom-made devices

change.significant-change-custom-made-notification

Fact-level verified

The conditions and procedure for notifying the placing on the market of a custom-made device, a significant change made to a custom-made device, and the first distribution of a device in Estonia are laid down by regulation of the minister responsible for the field, made under § 26(5) of the Medical Devices Act.

Conditions

The minister's regulation is the instrument established under § 26(5); this fact records only the delegation and the change-notification duty it covers.
For devices relying on the MDR transitional periods, Regulation (EU) 2023/607 requires that there be no significant changes in design and intended purpose.

Effective from 2023-01-01

Estonian source. Verbatim: "(5) Tellimusmeditsiiniseadme turul kättesaadavaks tegemisest, tellimusmeditsiiniseadmel tehtud olulisest muudatusest ja meditsiiniseadme esmakordsest Eestis levitamisest teavitamise tingimused ja korra kehtestab valdkonna eest vastutav minister määrusega."

Classification rules

What local class follows from which rules and decisive product facts?

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Risk classification under MDR Annex VIII

classification.mdr-risk-classes

Fact-level verified

Devices are divided into classes I, IIa, IIb and III taking into account the intended purpose and inherent risks, and classification is carried out in accordance with Annex VIII to Regulation (EU) 2017/745. Estonia sets no separate national classification of its own; the Medical Devices Act leaves classification to the directly applicable Union rules.

Conditions

For in vitro diagnostic medical devices the Union classes are A, B, C and D under IVDR Annex VIII.

Effective from 2021-05-26

English source. Verbatim: "1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII."

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Estonia's national addition: Ravimiamet's authorisation for a sponsor not established in the EU to designate a contact person

clinical.contact-person-authorisation-for-non-eu-sponsors

Fact-level verified

Where a study is planned to be conducted only in Estonia, or only in Estonia and in a country that is not a European Union or European Economic Area member state, and the sponsor is not registered in a European Union member state, Ravimiamet may, on the sponsor's application, authorise the sponsor to designate a contact person for the study in its place, proceeding from Article 62(2) of Regulation (EU) 2017/745 or Article 58(4) of Regulation (EU) 2017/746 respectively. Ravimiamet grants that authorisation where it carries no significant risks to the safety or rights of study participants and the requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and in the Medical Devices Act are met. A sponsor wishing to designate a contact person in its place may submit the study application documents to Ravimiamet after it has received the authorisation to use a contact person.

Conditions

Companion national duties in the same section: the sponsor must ensure insurance cover for any health damage arising from participation (compensation covering the sponsor's and the investigator's liability, matching the nature and extent of the risk) and must submit the insurance policy or a copy with the study application (§ 21¹(5)); documents named in Annex XV MDR or Annex XIII IVDR may be drawn up in Estonian or English, except the documents used to obtain informed consent, which must be in the participant's mother tongue (§ 21¹(6)); the sponsor, its legal representative or its contact person must keep the investigational device and study information and documents available to the competent authority for the retention period and in the manner provided in Article 3 of Chapter III of Annex XV MDR or Article 3 of Chapter II of Annex XIV IVDR (§ 21¹(7)).
This is the authorisation to use a contact person, not an authorisation of the study: the study itself still runs through the study application.

Language of source: Estonian. Verbatim § 21¹(1): "Kui uuring kavandatakse teha ainult Eestis või ainult Eestis ja muus riigis kui Euroopa Liidu liikmesriik või Euroopa Majanduspiirkonna liikmesriik ning sponsor ei ole registreeritud mõnes Euroopa Liidu liikmesriigis, võib Ravimiamet anda sponsori taotluse korral sponsorile loa määrata enda asemel uuringuga seotud kontaktisik, lähtudes vastavalt Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 artikli 62 lõikes 2 või määruse (EL) 2017/746 artikli 58 lõikes 4 sätestatust." (2): "Ravimiamet annab käesoleva paragrahvi lõikes 1 nimetatud loa, kui loa andmisega ei kaasne olulisi riske uuringus osalejate ohutusele ega õigustele ning täidetud on Euroopa Parlamendi ja nõukogu määruses (EL) 2017/745 või (EL) 2017/746 ja käesolevas seaduses sätestatud nõuded." (3): "Sponsor, kes käesoleva paragrahvi lõike 1 kohaselt soovib enda asemel määrata kontaktisiku, võib esitada Ravimiametile uuringu tegemiseks taotluse dokumendid (edaspidi uuringu taotlus) pärast seda, kui sponsor on saanud loa kasutada kontaktisikut." English translation: (1) 'Where a study is planned to be conducted only in Estonia or only in Estonia and in a country other than a European Union member state or a European Economic Area member state, and the sponsor is not registered in a European Union member state, Ravimiamet may, on the sponsor's application, authorise the sponsor to designate a contact person connected with the study in its place, proceeding respectively from Article 62(2) of Regulation (EU) 2017/745 or Article 58(4) of Regulation (EU) 2017/746.' (2) 'Ravimiamet grants the authorisation referred to in subsection 1 of this section where the grant of the authorisation carries no significant risks to the safety or rights of study participants and the requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 and in this Act are met.' (3) 'A sponsor who, under subsection 1 of this section, wishes to designate a contact person in its place may submit the study application documents to Ravimiamet after the sponsor has received the authorisation to use a contact person.'

Sponsor notification of low-intervention studies

clinical.sponsor-ten-day-notification

Fact-level verified

A sponsor must notify Ravimiamet at least ten days before starting a study where the sponsor plans to conduct a clinical investigation referred to in Article 74 of Regulation (EU) 2017/745 that entails procedures for participants that, beyond the procedures carried out under the device's normal conditions of use, are neither invasive nor burdensome, or a performance study referred to in Article 58(2) of Regulation (EU) 2017/746 that investigates a companion diagnostic using only residual samples.

Conditions

The provision sits in § 21¹ of the Medical Devices Act (the duties of the person conducting a clinical investigation of a medical device or a performance study of an in vitro diagnostic medical device, and of persons connected with the study), which otherwise requires an application to Ravimiamet for the right to conduct a study.
The ethics committee for clinical investigations of medicinal products and medical devices is established by regulation of the Minister of Social Affairs (RT I, 26.09.2025, 5), made under § 99²(6) of the Medicinal Products Act and § 21³(5) of the Medical Devices Act.
§ 21¹(4) is the notification route only; it does not displace the application route for other studies.

Language of source: Estonian. Verbatim, § 21¹(4) with both indents in full: "(4) Sponsor teavitab Ravimiametit vähemalt kümme päeva enne uuringu tegemise alustamist, kui ta kavandab teha: 1) Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 artiklis 74 nimetatud uuringut, millega kaasneb osalejatele peale seadme tavapäraste kasutustingimuste kohaselt tehtavatele protseduuride selliseid protseduure, mis ei ole invasiivsed ega koormavad; 2) Euroopa Parlamendi ja nõukogu määruse (EL) 2017/746 artikli 58 lõikes 2 nimetatud toimivusuuringut, milles uuritakse sobivusdiagnostikaseadet ja milles kasutatakse ainult proovide jääke." English translation: '(4) The sponsor shall notify Ravimiamet at least ten days before starting the study where it plans to conduct: 1) a study referred to in Article 74 of Regulation (EU) 2017/745 which entails, for the participants, beyond the procedures carried out in accordance with the device's normal conditions of use, procedures that are neither invasive nor burdensome; 2) a performance study referred to in Article 58(2) of Regulation (EU) 2017/746 which investigates a companion diagnostic and in which only residual samples are used.' CORRECTION TO THE PREVIOUS ROW: the earlier note recorded doubt because Riigi Teataja renders the sub-number of § 21¹ as a superscript. The consolidated text was re-read on 2026-09-16 and the structure is unambiguous: § 21¹ has subsections (1)–(7), this is subsection (4), and indents 1) and 2) are both reproduced above in full rather than elided. The row is otherwise the same claim against the same instrument; no new claim is made.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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Authority may qualify a product as a medical device

scope.authority-power-to-qualify-product-as-device

Fact-level verified

Ravimiamet has the power to determine that a product is a medical device where the product meets the requirements set out in Regulation (EU) 2017/745 or Regulation (EU) 2017/746 — that is, qualification follows the Union definition rather than a separate Estonian definition.

Conditions

The Medical Devices Act's own definitional sections (MSS §§ 3-10) were repealed when the Union definitions became applicable.

Effective from 2025-01-01

Estonian source. Verbatim: "(2) Ravimiametil on õigus määratleda toode meditsiiniseadmena, kui toode vastab Euroopa Parlamendi ja nõukogu määruses (EL) 2017/745 või (EL) 2017/746 sätestatud nõuetele."

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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What the Estonian Medical Devices Act adds to the dossier: retention of the documents available to Ravimiamet for the MDR/IVDR periods

dossier.national-document-retention-and-availability-to-ravimiamet

Fact-level verified

The national addition to the dossier regime is a retention and availability duty. Under § 25 of the Medical Devices Act the manufacturer or its authorised representative must keep device-related documents available to Ravimiamet for the following periods: at least ten or 15 years, as provided in Article 8 of Chapter III of Annex IX, Article 7 of Annex X, Articles 9 and 10.5 of Part A of Annex XI, Articles 17 and 18.4 of Part B of Annex XI and Article 4 of Annex XIII to Regulation (EU) 2017/745; and at least ten years, as provided in Article 7 of Chapter III of Annex IX, Article 6 of Annex X and Article 6 of Annex XI to Regulation (EU) 2017/746. § 2(1) of the same Act channels the national general layer: the obligations of the manufacturer, its authorised representative, the importer and the distributor, the notified body, conformity assessment of medical devices and market surveillance are subject to the requirements of the Product Conformity Act, with the derogations arising from the Medical Devices Act and from Regulations (EU) 2017/745 and (EU) 2017/746. The Estonian regime therefore does not add dossier content to the Union technical documentation; it adds who must hold it, for how long, and in what form of availability to the national authority.

Conditions

The retention periods are fixed by reference to specific MDR/IVDR annex points, not by a single national number of years, so the applicable period depends on the conformity-assessment route used for the device.
§ 2(1) makes the Product Conformity Act the national general law for operator obligations, notified bodies, conformity assessment and market surveillance, expressly subject to the Medical Devices Act and to MDR/IVDR — the Estonian pattern of 'Union rule plus national general law plus national derogations'.
No separate national dossier submission to Ravimiamet for a CE-marked device is created by § 25; the duty is to keep the documents available for the authority.

Language of source: Estonian. Verbatim § 25: "Tootja või tema volitatud esindaja peab säilitama Ravimiametile kättesaadavana meditsiiniseadmega seotud dokumente järgmiselt: 1) Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 IX lisa III peatüki punktis 8, X lisa punktis 7, XI lisa A osa punktides 9 ja 10.5, XI lisa B osa punktides 17 ja 18.4 ning XIII lisa punktis 4 sätestatu kohaselt – vähemalt kümme või 15 aastat; 2) Euroopa Parlamendi ja nõukogu määruse (EL) 2017/746 IX lisa III peatüki punktis 7, X lisa punktis 6 ja XI lisa punktis 6 sätestatu kohaselt – vähemalt kümme aastat." Verbatim § 2(1): "Meditsiiniseadme tootja, tema volitatud esindaja, importija ja levitaja kohustustele, teavitatud asutusele, meditsiiniseadme vastavushindamisele ja turujärelevalvele kohaldatakse toote nõuetele vastavuse seaduse nõudeid erisustega, mis tulenevad käesolevast seadusest ning Euroopa Parlamendi ja nõukogu määrustest (EL) 2017/745 ja (EL) 2017/746." English translation: § 25 'The manufacturer or its authorised representative must keep documents related to the medical device available to Ravimiamet as follows: (1) at least ten or 15 years, as provided in Article 8 of Chapter III of Annex IX, Article 7 of Annex X, Articles 9 and 10.5 of Part A of Annex XI, Articles 17 and 18.4 of Part B of Annex XI and Article 4 of Annex XIII to Regulation (EU) 2017/745; (2) at least ten years, as provided in Article 7 of Chapter III of Annex IX, Article 6 of Annex X and Article 6 of Annex XI to Regulation (EU) 2017/746.' § 2(1) 'The obligations of the manufacturer of a medical device, its authorised representative, the importer and the distributor, the notified body, the conformity assessment of medical devices and market surveillance are subject to the requirements of the Product Conformity Act with the derogations arising from this Act and from Regulations (EU) 2017/745 and (EU) 2017/746.'

The device dossier in Estonia is the technical documentation of MDR/IVDR, applied directly

dossier.union-technical-documentation-applies-directly

Fact-level verified

Estonia is a Member State of the European Union and applies Regulation (EU) 2017/745 and Regulation (EU) 2017/746 directly, so the device dossier is the technical documentation those Regulations require rather than a national dossier compiled for Ravimiamet. Under Article 10(4) MDR, manufacturers of devices other than custom-made devices must draw up and keep up to date technical documentation for those devices, such as to allow the conformity of the device with the requirements of the Regulation to be assessed, including the elements set out in Annexes II and III; for custom-made devices the documentation is that of Annex XIII Section 2. Article 10(8) requires the manufacturer to keep the technical documentation, the EU declaration of conformity and, where applicable, a copy of any relevant notified-body certificate available to the competent authorities for at least 10 years after the last device covered by the declaration of conformity has been placed on the market, or at least 15 years for implantable devices, and to provide the technical documentation in its entirety or a summary on request by a competent authority. Annex II sets out the technical documentation contents, beginning with device description and specification, including variants and accessories.

Conditions

This is a Union requirement applied directly in Estonia, not a national dossier rule; it is stated here because Estonia has no separate national dossier for the CE route. The national addition is the retention and availability duty in the companion fact on § 25 of the Medical Devices Act.
A manufacturer with a registered place of business outside the Union must ensure that its authorised representative has the necessary documentation permanently available, so that the representative can fulfil the tasks in Article 11(3) MDR (Art. 10(8), third subparagraph).

Language of source: English (EUR-Lex text of the Regulation). Verbatim Art. 10(4): "Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices. The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The technical documentation shall include the elements set out in Annexes II and III." Art. 10(5): "Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII." Art. 10(8): "Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56, available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market. In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market. Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof." Annex II verbatim: "The technical documentation and, if applicable, the summary thereof to be drawn up by the manufacturer shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements listed in this Annex."

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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Authorised representative required for non-EU manufacturers

operator.authorised-representative-required

Fact-level verified

Where the manufacturer of a device is not established in an EU Member State, the device may be placed on the Union market — including the Estonian market — only if the manufacturer designates a sole authorised representative; the mandate is effective at least for all devices of the same generic device group.

Conditions

Designation is valid only when accepted in writing by the authorised representative (MDR Art. 11(2)).
Ravimiamet states on its operator page that a non-EU manufacturer must appoint an authorised representative established in the European Union.

Effective from 2021-05-26

English source. Verbatim: "1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. 2. The designation shall constitute the authorised representative's mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group."

National duty framework for operators

operator.national-duty-framework

Fact-level verified

For the duties of the manufacturer, its authorised representative, the importer and the distributor, the Medical Devices Act applies the requirements of the Product Conformity Act (toote nõuetele vastavuse seadus) with the modifications arising from the Medical Devices Act and from Regulations (EU) 2017/745 and 2017/746; the same reference covers notified bodies, conformity assessment and market surveillance.

Conditions

No separate Estonian licence or permit is issued to importers or distributors; their substantive duties are the directly applicable MDR/IVDR duties.

Estonian source. Verbatim: "(1) Meditsiiniseadme tootja, tema volitatud esindaja, importija ja levitaja kohustustele, teavitatud asutusele, meditsiiniseadme vastavushindamisele ja turujärelevalvele kohaldatakse toote nõuetele vastavuse seaduse nõudeid erisustega, mis tulenevad käesolevast seadusest ning Euroopa Parlamendi ja nõukogu määrustest (EL) 2017/745 ja (EL) 2017/746."

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Notification of first distribution in Estonia

establishment.distributor-first-distribution-notification

Fact-level verified

Every undertaking that distributes on the Estonian market a system or procedure pack within the meaning of MDR Article 22, a class IIa, IIb or III medical device classified under Regulation (EU) 2017/745 or under Directive 90/385/EEC or 93/42/EEC, or a class B, C or D in vitro diagnostic medical device classified under IVDR Annex VIII, must notify Ravimiamet within ten days of the first distribution of that device. Ravimiamet states that notification of class I and class A devices is recommended but not mandatory.

Conditions

The provision names the repealed Directives 90/385/EEC and 93/42/EEC expressly, so legacy-classified devices (including active implantable devices under 90/385/EEC, as Ravimiamet reads it) are covered.
Notification is submitted through the Estonian medical devices and aids database (MSA/EMDDB); Ravimiamet states there is no fee.
Ravimiamet states that the EUDAMED roll-out does not remove this national distribution-notification duty.

Effective from 2023-01-01

Regulation in the field of medical devices in Estonia

Estonian source. Verbatim (device-class enumerations elided with …): "(4) Iga ettevõtja, kes levitab Eesti turul Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 artikli 22 kohast meditsiiniseadmete süsteemi või protseduuripaketti või … IIa, IIb või III riskiklassi meditsiiniseadet või … B-, C- või D-klassi in vitro diagnostikameditsiiniseadet, teavitab sellest Ravimiametit kümne päeva jooksul asjaomase meditsiiniseadme esmakordsest levitamisest arvates."

Estonian medical devices and aids database (MSA)

establishment.msa-database-data-submission

Fact-level verified

Manufacturers or their authorised representatives, importers, distributors, professional users and lay users of medical devices, sellers and lessors of aids, and Tervisekassa submit data to the Estonian medical devices and aids database (meditsiiniseadmete ja abivahendite andmekogu, MSA); Ravimiamet is the controller of the database. The database holds data on placing custom-made devices, systems and procedure packs on the market, on the distribution of devices in Estonia, on incident registration, on investigations and on supervision proceedings.

Conditions

The database is established and its statutes are laid down by the minister responsible for the field (§ 29(4)).
Ravimiamet's free sale certificate service requires the devices to be recorded in the MSA register with up-to-date data.

Effective from 2023-04-01

Estonian source. Verbatim (2), opening and listed submitters: "(2) Meditsiiniseadmete ja abivahendite andmekogusse esitavad andmeid: 1) meditsiiniseadme tootja või tootja volitatud esindaja; 2) meditsiiniseadme importija; 3) meditsiiniseadme levitaja; …"; verbatim (5): "(5) Meditsiiniseadmete ja abivahendite andmekogu vastutav töötleja on Ravimiamet."

Fees

What regulator fee applies to this class, route, event, and date?

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Cap on Ravimiamet charges for paid services

fees.ravimiamet-paid-services-cap

Fact-level verified

Ravimiamet may provide paid services connected with its main activity that ensure compliance with medical device quality and safety requirements, and the charge for one service may not exceed 20,000 euro. The list of paid services and the rates are established by regulation of the minister responsible for the field.

Conditions

The paid services must not obstruct the agency's statutory tasks and must relate to its MDR/IVDR tasks, to the market situation for the same services, or to providing a scientific opinion to a notified body.
By contrast, state supervision and the notification of first distribution are not charged for.

Effective from 2025-01-01

Estonian source. Verbatim (3): "(3) Ravimiameti tasu ühe teenuse osutamise eest ei tohi olla suurem kui 20 000 eurot." Verbatim (4): "(4) Käesoleva paragrahvi lõikes 1 nimetatud Ravimiameti tasuliste teenuste loetelu ja tasumäärad kehtestab valdkonna eest vastutav minister määrusega." A further cap of 20,000 euro applies to the notified body designation and assessment procedure fee in § 32⁴.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Language of the declaration of conformity and notified body certificates

label.declaration-of-conformity-and-certificate-language

Fact-level verified

The EU declaration of conformity of a device distributed in Estonia must be drawn up in Estonian or English, or translated into Estonian or English; a notified body registered in Estonia issues its conformity certificates in Estonian or English.

Conditions

This is a national addition; MDR Article 19 requires the declaration of conformity to be drawn up in an official Union language determined by the Member State concerned.

Effective from 2023-01-01

Estonian source. Verbatim (5): "(5) Eestis levitatava meditsiiniseadme vastavusdeklaratsioon peab olema koostatud eesti või inglise keeles või tõlgitud eesti või inglise keelde." Verbatim (6): "(6) Eestis registreeritud teavitatud asutus väljastab vastavussertifikaadid eesti või inglise keeles."

Language of device information supplied with the device

label.device-information-language

Fact-level verified

Information accompanying a device placed on the market, made available, distributed or put into service in Estonia must be presented: in Estonian, in an appropriate manner, where the device is intended for lay users; in Estonian or English where the device is intended only for professional users; and in a language understandable to the specific user for a custom-made device. Other information accompanying the device may be in another EU or EEA Member State language understandable to potential users.

Conditions

Where information is supplied in English for professional users, Ravimiamet advises the user and supplier to agree this in advance, and states the professional user retains the right to demand the information in Estonian.
The Union labelling and translation requirements of MDR/IVDR, including MDR Article 16, must also be met.

Effective from 2023-01-01

Estonian source. Verbatim (3), lead-in: "(3) Tootja, toetudes riskianalüüsile, teeb kindlaks seadme ohutuks ja sihtotstarbekohaseks kasutamiseks vajaliku info ning Eestis turule lastava, turul kättesaadavaks tehtava, levitatava ja kasutusele võetava meditsiiniseadmega kaasnev teave esitatakse: 1) eesti keeles ja sobivas laadis, kui meditsiiniseade on mõeldud kasutamiseks tavakasutajale; 2) eesti või inglise keeles ja sobivas laadis, kui meditsiiniseade on mõeldud kasutamiseks ainult professionaalsele kasutajale; 3) konkreetsele kasutajale arusaadavas keeles ja sobivas laadis, kui tegemist on tellimusmeditsiiniseadmega." Verbatim (4): "(4) Erinevalt käesoleva paragrahvi lõikes 3 sätestatust võib meditsiiniseadmega kaasnev ülejäänud teave olla esitatud mõnes muus potentsiaalsele kasutajale arusaadavas Euroopa Liidu liikmesriigi või Euroopa Majanduspiirkonna liikmesriigi keeles."

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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National act governing medical devices

legal-basis.national-medical-devices-act

Fact-level verified

The Estonian national act for medical devices is the Medical Devices Act (Meditsiiniseadme seadus, MSS), passed 13 October 2004 and published RT I 2004, 75, 520, in force since 1 December 2004. The consolidated text in force at the research date is RT I, 12.07.2025, 23, valid 1 October 2025 to 30 September 2026.

Conditions

The registry brief described the governing act as the Medicinal Products Act (Ravimiseadus); that is the medicines act. The device act is a separate statute, the Medical Devices Act.

Effective from 2025-10-01

Estonian source. Verbatim fragments from the header: "Väljaandja: Riigikogu", "Meditsiiniseadme seadus 1 Vastu võetud 13.10.2004 RT I 2004, 75, 520 jõustumine 01.12.2004", "Avaldamismärge: RT I, 12.07.2025, 23", "Sõnastuse jõustumise kp: 01.10.2025 Sõnastuse kehtivuse lõpp: 30.09.2026".

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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Manufacturer post-market surveillance system

pms.manufacturer-post-market-surveillance-system

Fact-level verified

For each device, manufacturers must plan, establish, document, implement, maintain and update a post-market surveillance system in a manner proportionate to the risk class and appropriate to the type of device; the system is an integral part of the manufacturer's quality management system under Article 10(9) of Regulation (EU) 2017/745.

Conditions

The system must actively and systematically gather, record and analyse data on quality, performance and safety throughout the device's lifetime and draw the necessary conclusions.
Estonia adds no separate national PMS system; MSS § 25 sets documentation retention periods of at least ten or fifteen years, available to Ravimiamet.

Effective from 2021-05-26

English source. Verbatim: "1. For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(9)."

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Free sale certificate: the statutory rule for the application and the certificate

forms.free-sale-certificate-application

Fact-level verified

The free sale certificate is a statutory service under § 32² of the Medical Devices Act. Ravimiamet issues it, on application, to a manufacturer or authorised representative registered in Estonia, for the export of a medical device; the certificate evidences that the applicant's registered place of business is in the Republic of Estonia and that the relevant CE-marked medical device may be marketed in the European Union. The certificate is drawn up in English and in one copy, and is issued on paper. The manufacturer or its authorised representative applying for the certificate or a duplicate of it must, before submitting the application, pay the state fee for the issue of the certificate or duplicate in accordance with the State Fees Act. The certificate is valid for two years from the date of issue, unless the validity period of the medical device's conformity certificate is shorter. In practice the application is made on the form published in the medical devices section of Ravimiamet's website with the list of devices to be covered, and the completed form is sent to the medical devices department by email; before a certificate is issued the devices must be recorded in the medical devices register with up-to-date data and valid documents (declaration of conformity, EC certificate where applicable, label and instructions).

Conditions

The statutory rule (application, addressee, content, language, form, state fee, two-year validity) is in § 32² of the Medical Devices Act. The filing practicalities — the published form, the list of devices, the email to the medical devices department, and the precondition that the devices be recorded in the register with valid documents — come from Ravimiamet's service page, not from the Act, and are stated here on that basis.
There is no dedicated online portal for this service; the medical devices notification service runs through the medical devices register.
The certificate is an export document evidencing Estonian establishment and EU marketability of a CE-marked device; it is not a marketing authorisation and does not replace CE marking.
The state fee amount is not stated here; § 32²(3) fixes it by reference to the State Fees Act.

Vabamüügi sertifikaat (Free sale certificate) — Ravimiamet service page

Language of source: Estonian (statute); the service page is in Estonian as well. Verbatim § 32²(1): "Ravimiamet väljastab Eestis registreeritud tootjale või volitatud esindajale taotluse alusel meditsiiniseadme ekspordiks vabamüügi sertifikaadi, mis tõendab, et tootja või volitatud esindaja registreeritud tegevuskoht on Eesti Vabariigis ning CE-märgist kandvat asjaomast meditsiiniseadet võib Euroopa Liidus turustada." (2): "Vabamüügi sertifikaat koostatakse inglise keeles ja ühes eksemplaris ning väljastatakse paberil." (3): "Vabamüügi sertifikaati või selle duplikaati taotlev tootja või tema volitatud esindaja on kohustatud enne taotluse esitamist tasuma vabamüügi sertifikaadi või selle duplikaadi väljastamise eest riigilõivu riigilõivuseaduse kohaselt." (4): "Vabamüügi sertifikaat kehtib kaks aastat alates väljastamisest, välja arvatud juhul, kui meditsiiniseadme vastavussertifikaadi kehtivusaeg on lühem." English translation: (1) 'Ravimiamet issues, on application, to a manufacturer or authorised representative registered in Estonia a free sale certificate for the export of a medical device, which certifies that the registered place of business of the manufacturer or authorised representative is in the Republic of Estonia and that the relevant CE-marked medical device may be marketed in the European Union.' (2) 'The free sale certificate is drawn up in English and in one copy and is issued on paper.' (3) 'A manufacturer or its authorised representative applying for a free sale certificate or a duplicate thereof must, before submitting the application, pay the state fee for the issue of the free sale certificate or its duplicate in accordance with the State Fees Act.' (4) 'The free sale certificate is valid for two years from the date of issue, unless the validity period of the medical device's conformity certificate is shorter.' This row replaces the earlier service-page value; the statutory rule is now the value, the service-page practicalities sit in conditions, and the service page is recorded as a supporting source so a reader can see which part rests on which document.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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Ravimiamet's state supervision over devices and the inspection measures it may use

inspection.market-surveillance-authority-and-inspection-measures

Fact-level verified

State and administrative supervision over compliance with the requirements laid down in the Medical Devices Act, in legislation adopted under it, and in Regulations (EU) 2017/745 and (EU) 2017/746 is carried out by Ravimiamet; supervision over the requirements of Chapter 3 of the Act in the provision of health services is carried out by Terviseamet. For state supervision the law-enforcement body may apply the special state-supervision measures provided in §§ 30, 31, 32, 49 and 50 of the Law Enforcement Act, on the grounds and under the procedure set out there; the measure provided in § 50 of that Act may be applied in the presence of the person checked, its representative or its employee. Ravimiamet may involve experts in checking a device's conformity and order a conformity assessment service for a device or its parts under the regulation made under § 22(10) of the Act; the assessment service is formalised as an expert opinion describing the results of the analysis, tests and expertise. Ravimiamet pays the cost of the ordered assessment service and returns the device or compensates direct material damage where the device is found to be conformant, and where the device is not conformant the undertaking concerned reimburses Ravimiamet for the assessment service.

Conditions

The inspection is of devices and operators on the Estonian market; the manufacturer's quality management system audit is not performed by Ravimiamet but by a notified body under MDR Annex IX — see the companion fact on the Union QMS route.
The Medical Devices Act's own challenge provision for a precept or a measure was repealed (§ 37, repealed by RT I, 13.03.2014, 4, in force 01.07.2014), so an inspection measure is contested under the general administrative-law remedy.
Ravimiamet is also the competent authority and the authority responsible for notified bodies under MDR/IVDR (§ 14¹(1)) and may determine a product to be a medical device if it meets the requirements of MDR or IVDR (§ 14¹(2)).

Language of source: Estonian. Verbatim § 33(1): "Käesolevas seaduses ja selle alusel kehtestatud õigusaktides ning Euroopa Parlamendi ja nõukogu määrustes (EL) 2017/745 ja (EL) 2017/746 sätestatud nõuete täitmise üle teeb riiklikku ja haldusjärelevalvet Ravimiamet." § 33(2): "Käesoleva seaduse 3. peatükis sätestatud nõuete täitmise üle tervishoiuteenuse osutamisel teeb riiklikku ja haldusjärelevalvet Terviseamet." § 34: "Korrakaitseorgan võib käesolevas seaduses sätestatud riikliku järelevalve teostamiseks kohaldada korrakaitseseaduse §-des 30, 31, 32, 49 ja 50 sätestatud riikliku järelevalve erimeetmeid korrakaitseseaduses sätestatud alusel ja korras." § 34¹(1): "Korrakaitseorgan võib korrakaitseseaduse §-s 50 sätestatud meedet kohaldada kontrollitava isiku, tema esindaja või tema töötaja juuresolekul." § 35(1): "Ravimiametil on lubatud meditsiiniseadme nõuetele vastavuse kontrollimisse kaasata eksperte ning tellida meditsiiniseadmete või nende osade nõuetele vastavuse kontrollimiseks hindamisteenust käesoleva seaduse § 22 lõike 10 alusel kehtestatud määruse kohaselt." § 35(2): "Hindamisteenus vormistatakse eksperdiarvamusena, milles kirjeldatakse analüüsi-, katse- ja ekspertiisitulemusi." § 35(3): "Ravimiamet tasub meditsiiniseadme nõuetele vastavuse kontrollimiseks tellitud hindamisteenuse kulud ning tagastab meditsiiniseadme või hüvitab tekitatud otsese varalise kahju, kui meditsiiniseade on eksperdiarvamuse järgi nõuetekohane. Kui meditsiiniseade ei ole eksperdiarvamuse järgi nõuetekohane, hüvitab asjaomane ettevõtja Ravimiametile hindamisteenuse kulud." English translation: § 33(1) 'State and administrative supervision over compliance with the requirements laid down in this Act and the legislation adopted under it and in Regulations (EU) 2017/745 and (EU) 2017/746 is carried out by Ravimiamet.' § 33(2) 'State and administrative supervision over compliance with the requirements laid down in Chapter 3 of this Act in the provision of health services is carried out by Terviseamet.' § 34 'In order to carry out the state supervision provided for in this Act, the law-enforcement body may apply the special state-supervision measures provided in §§ 30, 31, 32, 49 and 50 of the Law Enforcement Act on the grounds and under the procedure laid down in that Act.' § 35(1) 'Ravimiamet may involve experts in checking the conformity of a medical device and order a conformity assessment service for medical devices or their parts under the regulation established under § 22(10) of this Act.'

What the Estonian act adds to the Union QMS route: notified-body oversight and Ravimiamet's competent-authority role

inspection.notified-body-oversight-and-competent-authority-role

Fact-level verified

The Estonian act adds the national institutional layer to the Union conformity-assessment route. Under § 14(2) of the Medical Devices Act the notified body, its activity, the grant of its operating licence, the suspension or revocation of that licence, and state supervision over it are subject to the Product Conformity Act, with the derogations arising from the Medical Devices Act and from Regulations (EU) 2017/745 and (EU) 2017/746. Under § 14¹(1) Ravimiamet performs the acts and issues the administrative acts of the competent authority and of the authority responsible for notified bodies provided for in the Medical Devices Act and in Regulations (EU) 2017/745 and (EU) 2017/746, unless those Regulations provide otherwise; under § 14¹(2) Ravimiamet may determine a product to be a medical device if the product meets the requirements laid down in Regulation (EU) 2017/745 or Regulation (EU) 2017/746.

Conditions

Notification and designation of a body as a notified body under MDR Chapter IV is a Union process; the Estonian additions are the operating licence under the Product Conformity Act and national supervision, and the language requirements for the designation application (§ 32⁵).
§ 14(1) of the Act is repealed (RT I, 22.12.2022, 2, in force 01.01.2023); only § 14(2) is in force.
The fees for the designation application, review, notification and operating licence, and for assessment, periodic assessment and re-assessment of a notified body, are set by §§ 32⁶ and 32⁷ of the Act and are not part of this fact.

Language of source: Estonian. Verbatim § 14(2): "Teavitatud asutusele, tema tegutsemisele, temale tegevusloa andmisele, selle kehtivuse peatamisele või kehtetuks tunnistamisele ning tema üle riikliku järelevalve tegemisele kohaldatakse toote nõuetele vastavuse seadust käesolevast seadusest ning Euroopa Parlamendi ja nõukogu määrustest (EL) 2017/745 ja (EL) 2017/746 tulenevate erisustega." § 14²(1): "Käesolevas seaduses ning Euroopa Parlamendi ja nõukogu määrustes (EL) 2017/745 ja (EL) 2017/746 sätestatud pädeva asutuse ja teavitatud asutuse eest vastutava asutuse toimingud teeb ja haldusaktid annab Ravimiamet, kui nimetatud määrustes ei ole sätestatud teisiti." § 14²(2): "Ravimiametil on õigus määratleda toode meditsiiniseadmena, kui toode vastab Euroopa Parlamendi ja nõukogu määruses (EL) 2017/745 või (EL) 2017/746 sätestatud nõuetele." English translation: § 14(2) 'The notified body, its activity, the grant of its operating licence, the suspension or revocation of the licence, and state supervision over it are subject to the Product Conformity Act with the derogations arising from this Act and from Regulations (EU) 2017/745 and (EU) 2017/746.' § 14²(1) 'The acts of the competent authority and of the authority responsible for notified bodies provided for in this Act and in Regulations (EU) 2017/745 and (EU) 2017/746 are performed and the administrative acts are issued by Ravimiamet, unless otherwise provided in those Regulations.' § 14²(2) 'Ravimiamet has the right to determine a product to be a medical device if the product meets the requirements laid down in Regulation (EU) 2017/745 or (EU) 2017/746.'

The quality-management-system duty and the conformity-assessment route for devices in Estonia are the Union ones, with the notified-body audit under MDR Annex IX

qms.union-quality-management-system-requirement-and-conformity-assessment-route

Fact-level verified

The quality management system obligation that applies to a device placed on the Estonian market is the Union one. Article 10(9) MDR requires manufacturers of devices other than investigational devices to establish, document, implement, maintain, keep up to date and continually improve a quality management system that ensures compliance with the Regulation in the most effective manner and in a manner proportionate to the risk class and the type of device, covering all parts and elements of the manufacturer's organisation dealing with the quality of processes, procedures and devices, and addressing at least a regulatory-compliance strategy including management of modifications, identification of the applicable general safety and performance requirements, responsibility of the management, resource management including selection and control of suppliers and subcontractors, risk management under Annex I Section 3, and clinical evaluation including PMCF. Article 52 requires a manufacturer to undertake an assessment of conformity under Annexes IX to XI before placing a device on the market: class III devices under Annex IX, or Annex X coupled with Annex XI; class IIb devices under Chapters I and III of Annex IX including assessment of the technical documentation of at least one representative device per generic device group (and for class IIb implantables other than the listed exceptions, of every device), or Annex X coupled with Annex XI; class IIa devices under Chapters I and III of Annex IX with technical-documentation assessment of at least one representative device per category, or the Annexes II and III documentation coupled with Section 10 or Section 18 of Annex XI; and class I devices by EU declaration of conformity after drawing up the Annex II and III technical documentation, with notified-body involvement limited to sterility, measuring function or reusability where those apply.

Conditions

This is the Union route applied directly; the Estonian act does not create a national QMS approval. The national layer is in the companion fact on notified-body oversight and Ravimiamet's competent-authority role.
Annex IX Chapter I of MDR is the quality-management-system chapter, so a class IIa, IIb or III device is audited against its QMS by a notified body; the audit is not carried out by Ravimiamet.
Article 10(6) requires an EU declaration of conformity under Article 19 and CE marking under Article 20 once conformity has been demonstrated; Article 10(7) binds the manufacturer to the UDI obligations of Article 27 and the registration obligations of Articles 29 and 31.

Language of source: English (EUR-Lex text of the Regulation). Verbatim Art. 10(9): "Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device. The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation. The quality management system shall address at least the following aspects: (a) a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system; (b) identification of applicable general safety and performance requirements and exploration of options to address those requirements; (c) responsibility of the management; (d) resource management, including selection and control of suppliers and sub-contractors; (e) risk management as set out in in Section 3 of Annex I; (f) clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;" Verbatim Art. 52(1): "Prior to placing a device on the market, manufacturers shall undertake an assessment of the conformity of that device, in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI." Art. 52(7): "Manufacturers of class I devices, other than custom-made or investigational devices, shall declare the conformity of their products by issuing the EU declaration of conformity referred to in Article 19 after drawing up the technical documentation set out in Annexes II and III."

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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Supervisory measures available to Ravimiamet

recall.supervision-and-special-measures

Fact-level verified

For the state supervision provided for in the Medical Devices Act, the supervising authority may apply the special state supervision measures of §§ 30, 31, 32, 49 and 50 of the Law Enforcement Act (korrakaitseseadus) on the grounds and under the procedure set out there; the supervising authority is Ravimiamet and it may involve experts and commission conformity-assessment testing of devices or their parts.

Conditions

Field safety corrective actions are reported under MDR Article 87(1)(b), evidenced separately in this file.
The measure in § 50 of the Law Enforcement Act may be applied in the presence of the person checked, its representative or its employee (§ 34¹(1)); failure to comply with a precept is enforced by a coercive fine capped at EUR 32,000 (§ 36); orders are challengeable under the general administrative procedure rules.

Estonian source. Verbatim: "(1) Korrakaitseorgan võib käesolevas seaduses sätestatud riikliku järelevalve teostamiseks kohaldada korrakaitseseaduse §-des 30, 31, 32, 49 ja 50 sätestatud riikliku järelevalve erimeetmeid korrakaitseseaduses sätestatud alusel ja korras." The supervising authority is fixed by MSS § 33(1), and the expert-involvement power by § 35(1), both evidenced in this file.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Custom-made device notification

pathway.custom-made-device-notification

Fact-level verified

Any undertaking that places a custom-made device on the market must notify Ravimiamet of its intention at least ten days before making that device available on the market.

Conditions

Notification goes through the Estonian medical devices and aids database (MSA), not EUDAMED, because custom-made devices are not registered in EUDAMED.
The detailed conditions and procedure are laid down by the minister under § 26(5).

Estonian source. Verbatim: "(3) Iga ettevõtja, kes teeb turul kättesaadavaks tellimusmeditsiiniseadme, teavitab vähemalt kümme päeva enne sellise meditsiiniseadme turul kättesaadavaks tegemist Ravimiametit kavatsusest selline meditsiiniseade turul kättesaadavaks teha."

In-house manufactured devices listing

pathway.in-house-manufacture-listing

Fact-level verified

A health care provider, or a research and development institution, university or evaluated professional higher education institution that manufactures devices in-house under MDR Article 5(5) or IVDR Article 5(5), must publish the list of those devices on its website and submit the list to Ravimiamet within ten working days of publication on the website.

Conditions

Introduced by the amendment published RT I, 12.07.2025, 1, in force 1 October 2025.

Effective from 2025-10-01

Estonian source. Verbatim, opening and closing: "(1) Tervishoiuteenuse osutaja või … teadus- ja arendusasutus, ülikool või evalveeritud rakenduskõrgkool, kes Euroopa Parlamendi ja nõukogu määruse (EL) 2017/745 artikli 5 lõike 5 kohaselt või määruse (EL) 2017/746 artikli 5 lõike 5 kohaselt valmistab asutusesiseselt meditsiiniseadmeid (edaspidi asutusesisene valmistaja), avalikustab nende meditsiiniseadmete loetelu oma veebilehel ja esitab loetelu Ravimiametile kümne tööpäeva jooksul veebilehel avaldamisest arvates."

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Estonia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Estonia (3 records)

EstoniaEU conformity assessment

Prior approval / evidence record

CE marking under MDR/IVDR is the domestic route

reliance.eu-ce-marking-domestic-route

Fact-level verified

Statement: For Estonia the CE marking route is not a foreign approval but the domestic route: Regulations (EU) 2017/745 and (EU) 2017/746 apply directly in Estonia and the Estonian Medical Devices Act does not apply where those regulations apply, so a device holding a valid MDR/IVDR conformity assessment enters the Estonian market through the Union route. Only the national residual duties attach: notification of first distribution (MSS § 26(4)), Estonian-language information (MSS § 16(3)-(5)), data submission to the MSA register (MSS § 29) and the Union registration duties.
Source Approval: EU CE marking under Regulation (EU) 2017/745 (MDR) or Regulation (EU) 2017/746 (IVDR)
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Product Marketing
Local Application Required: No
Target Decision Retained: Yes

Conditions

Estonia is an EU member state, so the recognition runs through the Union single market rather than through a bilateral instrument.
The Medical Devices Act's own market-placement conditions in § 16(1)-(2) were repealed with effect from 1 January 2023; the placement rule now rests on the directly applicable Union regulations.
National residual duties listed in the statement are each evidenced by their own fact in this file.

Effective from 2023-01-01

Estonian source. Verbatim: "(2) Käesolevat seadust ei kohaldata juhtudel, kui kohaldub Euroopa Parlamendi ja nõukogu määrus (EL) 2017/745, milles käsitletakse meditsiiniseadmeid, ... või Euroopa Parlamendi ja nõukogu määrus (EL) 2017/746 in vitro diagnostikameditsiiniseadmete kohta ning millega tunnistatakse kehtetuks direktiiv 98/79/EÜ ja komisjoni otsus 2010/227/EL (ELT L 117, 05.05.2017, lk 176–332)." Consolidated text RT I, 12.07.2025, 23, in force 01.10.2025–30.09.2026.

EstoniaUS FDA

Prior approval / evidence record

FDA 510(k)/PMA

Authority: FDA 510(k)/PMA
Accepted: No
Benefit: No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

EUR-Lex Regulation (EU) 2017/745 (MDR)Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23 — § 26(3)-(4) notifications, § 27(1) incident registration, § 29(2) and (5) the medical devices and aids database Riigilõivuseadus (State Fees Act) § 28⁵⁴ — free-sale certificate issued within 45 days, or within five working days at the applicant's request

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

EstoniaUS FDA

Prior approval / evidence record

US FDA clearance: no recognition route into Estonia

reliance.us-fda-no-recognition-route

Fact-level verified

Statement: A US FDA 510(k), De Novo or PMA clearance gives no market-access route in Estonia. Estonia applies Regulation (EU) 2017/745 directly and a device may be placed on the Estonian market only if it complies with that Regulation; the Regulation provides for conformity assessment under Annexes IX to XI and contains no reliance or abridged procedure based on a third-country marketing authorisation. An FDA-only holder must obtain CE marking under MDR (or IVDR for IVDs) and designate an EU authorised representative.
Source Jurisdiction Id: usa
Source Authority Id: fda
Source Approval: US FDA 510(k) clearance, De Novo grant or PMA approval
Target Jurisdiction Id: estonia
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

No Estonian or Union instrument recognises an FDA clearance as a substitute for CE marking; the Medical Devices Act contains no third-country approval provision.
A non-EU manufacturer must designate a sole authorised representative in the Union (MDR Art. 11).
The same answer applies to a PMDA-, MFDS- or NMPA-only holder: none of those approvals opens a route; only the Union conformity-assessment route exists.

Effective from 2021-05-26

English source. Verbatim text: "A device may be placed on the market or put into service only if it complies with this Regulation when duly supplied and properly installed, maintained and used in accordance with its intended purpose." The Estonian national act expressly disapplies itself where the Union regulations apply (MSS § 1(2), separately evidenced in this file).

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

Ravimiamet notifies its decision on a clinical-investigation or performance-study application in the procedure of the MDR/IVDR; the Act sets no separate national period

clock.study-decision-notified-under-union-procedure

Fact-level verified

The sponsor applies to Ravimiamet to conduct a study, or to make a substantial modification to it, having regard to the requirements of the Act and of Regulation (EU) 2017/745 or (EU) 2017/746. Ravimiamet notifies its decision on the study application and on the modification notification in the procedure laid down in those Regulations; the Act contains no Estonian decision period, so the validation and decision periods of MDR Article 70 and IVDR Article 66 apply as the national handling.

Conditions

MDR Article 70(7)(b) requires notified authorisation before class III or invasive class IIa/IIb investigations start, with no valid negative ethics opinion. The 45-day authorisation period may extend 20 days for expert consultation and pauses for requested information under Article 70(6); expiry alone does not authorise commencement.
The sponsor pays a state fee for reviewing the application and an expert-assessment fee capped at EUR 3,000 (EUR 1,000 for a substantial modification) under section 22(5)–(6); an external expert opinion may add up to EUR 2,000 per assessment (section 22(8)).
Subsections 22(2)–(4), which formerly held national procedural rules, were repealed with effect from 01.10.2025.

Reporting is made in accordance with MDR Articles 92(5) and (7).
The Estonian implementing rule for registration of the reported incident and for the Estonian-language field safety notice is MSS § 27.

Effective from 2021-05-26

English source. Verbatim: "1. Manufacturers of devices made available on the Union market, other than investigational devices, shall report, to the relevant competent authorities, in accordance with Articles 92(5) and (7), the following: (a) any serious incident involving devices made available on the Union market, except expected side-effects which are clearly documented in the product information and quantified in the technical documentation and are subject to trend reporting pursuant to Article 88; (b) any field safety corrective action in respect of devices made available on the Union market …"

National incident registration and field safety notice language

vigilance.national-incident-registration-and-notice-language

Fact-level verified

Ravimiamet registers the data of a serious incident reported to it and notifies the reporter of this within ten working days of submission of the data. A field safety notice concerning a device made available on the Estonian market must be drawn up in Estonian; the initial urgent notice may be in English.

Conditions

The incident data are held in the Estonian medical devices and aids database (MSS § 29(3)(2)).
The separate provision on notifying the European Commission and EEA member states of an incident (§ 28) was repealed with effect from 1 January 2023; that notification now follows the Union route.

Effective from 2023-01-01

Estonian source. Verbatim (1): "(1) Ravimiamet registreerib talle teatatud ohujuhtumi andmed ja teavitab sellest andmete esitajat kümne tööpäeva jooksul andmete esitamisest arvates." Verbatim (2): "(2) Eesti turul kättesaadavaks tehtud meditsiiniseadme kohta koostatakse valdkonna ohutusteatis eesti keeles. Kiireloomulise olukorra kohta esitatav esmane ohutusteatis võib olla ingliskeelne."

Related structured datasets

Classification systems · 1 record

Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →

estonia:medical-device

Jurisdiction Id

estonia

Domains

medical-device

Name

EU MDR classes I, Is, Im, Ir, IIa, IIb and III

Description

National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; the Estonian act adds no national class rule of its own.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
is
Label
Class Is
Normalized Risk Level
low
Id
im
Label
Class Im
Normalized Risk Level
low
Id
ir
Label
Class Ir
Normalized Risk Level
low
Id
iia
Label
Class IIa
Normalized Risk Level
medium
Id
iib
Label
Class IIb
Normalized Risk Level
high
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

Ravimiamet

Official Domains

riigiteataja.ee
ravimiamet.ee
eur-lex.europa.eu

Source Status

official-source-verified

Reference Sources

Title
Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23, § 1(2) (Seaduse reguleerimisala) and § 14¹(1)-(2)
Url
https://www.riigiteataja.ee/akt/112072025023
Reviewed On
2026-09-16
Supports
§ 1(2) disapplies the Estonian act where Regulations (EU) 2017/745 or 2017/746 apply, so the class is determined under the Union rules and not by any Estonian instrument: 'Käesolevat seadust ei kohaldata juhtudel, kui kohaldub Euroopa Parlamendi ja nõukogu määrus (EL) 2017/745 ... või ... määrus (EL) 2017/746'. § 14¹(1) makes Ravimiamet the competent authority and the authority responsible for notified bodies, and § 14¹(2) gives it the power to define a product as a medical device, which is the only national classification-adjacent power in the act.
Title
Ravimiamet — Regulation in the field of medical devices in Estonia
Url
https://www.ravimiamet.ee/en/medical-devices/medical-devices/regulation-field-medical-devices-estonia
Reviewed On
2026-09-16
Supports
The agency states that the two Union regulations are directly applicable in Estonia, that national additions and specifications are found in the national Medical Devices Act, and that the MDCG guidelines should be followed. It is a regulator topic page rather than the instrument, so it is cited only for the allocation of the field.

Inherited From Scheme Id

eu:medical-device

Source Title

Regulation (EU) 2017/745, Art. 51 and Annex VIII

Source Url

https://eur-lex.europa.eu/eli/reg/2017/745/oj

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Estonia registration →

Country

Estonia

Jurisdiction Id

estonia

Country Code

Flag

🇪🇪

Regulator

Ravimiamet

Regulator Abbrev

Ravimiamet

Region

europe

Tier

Risk Classification

4-class (I, IIa, IIb, III) — EU MDR

Classes

Id
class-i
Class Name
Class I
Risk Level
low
Pathway
Self-declaration (no notified body)
Official Timeline
Min
0
Max
0
Unit
days
Verification Status
official-verified
Official Source
Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Realistic Timeline
Min
6
Max
9
Notes
MDR Art. 52(7): non-sterile, non-measuring, non-reusable-surgical Class I devices are self-declared, so no authority or notified body reviews the file and there is no review clock
Elapsed time is EUDAMED actor and device registration plus the Estonian notification and database duties, none of which has a guaranteed processing time
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
estonia-first-distribution-notification
Class Name
Notification to Ravimiamet of the first distribution of a device on the Estonian market
Risk Level
high
Pathway
National notification under MSS § 26(4)
Official Timeline
Min
10
Max
10
Unit
days
Verification Status
official-verified
Official Source
Title
Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23 — § 26(3)-(4) notifications, § 27(1) incident registration, § 29(2) and (5) the medical devices and aids database
Url
https://www.riigiteataja.ee/akt/112072025023
Effective Date
2025-10-01
Accessed Date
2026-09-16
Realistic Timeline
Min
10
Max
20
Unit
days
Notes
This is a national reporting clock, not a review clock: 'Iga ettevõtja, kes levitab Eesti turul ... IIa, IIb või III riskiklassi meditsiiniseadet või ... B-, C- või D-klassi in vitro diagnostikameditsiiniseadet, teavitab sellest Ravimiametit kümne päeva jooksul asjaomase meditsiiniseadme esmakordsest levitamisest arvates'
The same ten-day period applies to a system or procedure pack within the meaning of MDR Article 22 and to an active implantable device, so one clock spans several risk classes rather than belonging to any single one
It binds the undertaking that distributes the device, which may be an importer or distributor rather than the manufacturer, and the notification does not gate the distribution
A separate ten-day period runs in advance of placing a custom-made device on the market (MSS § 26(3)), and a ten-working-day period applies to submitting the list of in-house manufactured devices (MSS § 26(1))
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
estonia-incident-registration-acknowledgement
Class Name
Ravimiamet registration of a reported serious incident and acknowledgement to the reporter
Risk Level
medium
Pathway
National acknowledgement clock under MSS § 27(1)
Official Timeline
Min
10
Max
10
Unit
working-days
Verification Status
official-verified
Official Source
Title
Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23 — § 26(3)-(4) notifications, § 27(1) incident registration, § 29(2) and (5) the medical devices and aids database
Url
https://www.riigiteataja.ee/akt/112072025023
Effective Date
2025-10-01
Accessed Date
2026-09-16
Realistic Timeline
Min
10
Max
25
Unit
working-days
Notes
Verbatim: 'Ravimiamet registreerib talle teatatud ohujuhtumi andmed ja teavitab sellest andmete esitajat kümne tööpäeva jooksul andmete esitamisest arvates'
This is the national acknowledgement of an incident report, not a market-entry clock, and it applies to every device class alike
A field safety notice for a device made available on the Estonian market must be drawn up in Estonian; the initial urgent notice may be in English (MSS § 27(2))
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
estonia-free-sale-certificate
Class Name
Ravimiamet free-sale certificate
Risk Level
low
Pathway
National certificate for export or for a foreign authority, under MSS § 32²
Official Timeline
Min
45
Max
45
Unit
days
Verification Status
official-verified
Official Source
Title
Riigilõivuseadus (State Fees Act) § 28⁵⁴ — free-sale certificate issued within 45 days, or within five working days at the applicant's request
Url
https://www.riigiteataja.ee/akt/RLS
Effective Date
2025-01-01
Accessed Date
2026-09-16
Realistic Timeline
Min
45
Max
60
Unit
days
Notes
This is the national competent-authority clock, not a conformity-assessment clock: State Fees Act § 28⁵⁴(1) charges EUR 154 for a certificate issued within 45 days of the application, and § 28⁵⁴(3) charges EUR 308 for one issued within five working days at the applicant's request
The published clock is a service period attached to the state fee rather than a decision deadline on a market-entry application, and it applies to every device class alike
A certificate is issued only once the devices are registered in the medical devices and aids database and the data are current, so the period is not a substitute for the registration duty
Ravimiamet's own service page still cites the repealed § 29⁸² of the State Fees Act as the legal basis for the fee; the provision now in force is § 28⁵⁴
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
FDA 510(k)/PMA
Accepted
No
Benefit
No substitute for EU MDR conformity assessment; useful as predicate documentation in the technical file

Key Requirements

EU Authorized Representative for non-EU manufacturers (MDR Article 11), who also performs the registration duties
Notification to Ravimiamet within ten days of the first distribution of a Class IIa, IIb or III device, an active implantable device, an MDR Article 22 system or procedure pack, or a Class B, C or D IVD (MSS § 26(4))
Data submission to the medical devices and aids database (meditsiiniseadmete ja abivahendite andmekogu, MSA), whose controller is Ravimiamet (MSS § 29(2), (5))
EUDAMED actor and device registration, with the first four EUDAMED modules mandatory since 28 May 2026; the national database registration for market placement is done exclusively through EUDAMED
Field safety notices in Estonian for devices made available on the Estonian market, with the initial urgent notice permitted in English (MSS § 27(2))
Free-sale certificate from Ravimiamet for export or for a foreign authority, on payment of the state fee of EUR 154 (45 days) or EUR 308 (five working days), state fee EUR 32 for a duplicate
Clinical investigations of medical devices and performance studies of IVDs are reviewed by Ravimiamet, with a state fee of EUR 210
Device features that are radio equipment must also meet määrus nr 46 — essential requirements, conformity assessment, CE marking and, where the category requires it, registration of the type; TTJA is the market-surveillance authority
A device that is a legal measuring instrument needs a national type-approval certificate from TTJA, with a state fee of EUR 240
Medical equipment that produces ionizing radiation needs a Keskkonnaamet radiation-activity licence (90 days, extendable by up to 90 days for high-risk activity) or a radiation-activity registration (30 days), applied for and paid through KOTKAS
Electrical and electronic equipment and batteries placed on the Estonian market carry the Waste Act producer duties — producer or producer-organisation status, self-monitoring, cost-bearing for collection and treatment, and distributor take-back

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources

Title
EUR-Lex Regulation (EU) 2017/745 (MDR)
Url
https://eur-lex.europa.eu/eli/reg/2017/745/oj
Accessed Date
2026-09-16
Title
Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)
Url
https://eur-lex.europa.eu/eli/reg_impl/2026/977/oj
Effective Date
2027-02-25
Accessed Date
2026-09-16
Title
Meditsiiniseadme seadus (Medical Devices Act), consolidated text RT I, 12.07.2025, 23 — § 26(3)-(4) notifications, § 27(1) incident registration, § 29(2) and (5) the medical devices and aids database
Url
https://www.riigiteataja.ee/akt/112072025023
Effective Date
2025-10-01
Accessed Date
2026-09-16
Title
Riigilõivuseadus (State Fees Act) § 28⁵⁴ — free-sale certificate issued within 45 days, or within five working days at the applicant's request
Url
https://www.riigiteataja.ee/akt/RLS
Effective Date
2025-01-01
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by Ravimiamet. Appoint a EU Authorized Representative.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to Ravimiamet including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
Ravimiamet reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. Ravimiamet may issue questions.
Duration
0 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, Ravimiamet issues Estonia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Estonia fees →

Jurisdiction Id

estonia

Country

Estonia

Country Code

Authority

Ravimiamet

Low Risk Local

Min: 0
Max: 308
Currency: EUR
Per Product: No

High Risk Local

Min: 777
Max: 2590
Currency: EUR
Per Product: No

Details

Id
first-distribution-notification-and-msa-registration
Item
Notification of the first distribution of a device on the Estonian market (MSS § 26(4)) and submission of data to the medical devices and aids database (MSS § 29)
Currency
EUR
Amount Local
0
Amount Local Formatted
EUR 0
Frequency
Per notification and per registration
Notes
Verified zero. The State Fees Act's device division ('4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵) contains exactly three charges — clinical-investigation review, the free-sale certificate and its duplicate, and conformity-assessment-body designation and notified-body notification — and sets no charge for the first-distribution notification or for database registration. The same division's provisions previously numbered §§ 29⁸¹-29⁸³, which covered those two device services, were repealed with effect from 1 January 2025 and replaced by §§ 28⁵³-28⁵⁵.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
clinical-investigation-application-review
Item
Review of an application to conduct a clinical investigation of a medical device, or a performance study of an in vitro diagnostic medical device
Currency
EUR
Amount Local
210
Amount Local Formatted
EUR 210.00
Frequency
Per application
Notes
State Fees Act § 28⁵³(1) and (2), each charged at EUR 210. In force since 1 January 2025.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
free-sale-certificate-standard
Item
Free-sale certificate (vabamüügi sertifikaat) issued within 45 days of application
Currency
EUR
Amount Local
154
Amount Local Formatted
EUR 154.00
Frequency
Per certificate
Notes
State Fees Act § 28⁵⁴(1). The section is one of the three device provisions that replaced the repealed § 29⁸², which Ravimiamet's service page still cites.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
free-sale-certificate-duplicate
Item
Duplicate of a free-sale certificate
Currency
EUR
Amount Local
32
Amount Local Formatted
EUR 32.00
Frequency
Per duplicate
Notes
State Fees Act § 28⁵⁴(2).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
free-sale-certificate-expedited
Item
Free-sale certificate issued within five working days of application, at the applicant's request
Currency
EUR
Amount Local
308
Amount Local Formatted
EUR 308.00
Frequency
Per certificate
Notes
State Fees Act § 28⁵⁴(3): 'Isiku soovil vabamüügi sertifikaadi väljastamise eest viie tööpäeva jooksul taotluse esitamisest arvates tasutakse riigilõivu 308 eurot.'
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
conformity-assessment-body-designation-review
Item
Review of an application for designation as a conformity assessment body
Currency
EUR
Amount Local
2590
Amount Local Formatted
EUR 2,590.00
Frequency
Per application
Notes
State Fees Act § 28⁵⁵(1). This is a notified-body designation charge rather than a manufacturer charge; the Medical Devices Act caps a single Ravimiamet service fee at EUR 20,000 (§ 15¹(3)).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
notified-body-notification-and-licence
Item
Notification of a notified body's designation and issue of its operating licence
Currency
EUR
Amount Local
777
Amount Local Formatted
EUR 777.00
Frequency
Per notification
Notes
State Fees Act § 28⁵⁵(2).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16
Id
national-metrology-type-approval
Item
Review of an application for a national type-approval certificate for a measuring instrument (riigisisese tüübikinnitustunnistuse taotluse läbivaatamine)
Currency
EUR
Amount Local
240
Amount Local Formatted
EUR 240.00
Frequency
Per application
Notes
State Fees Act § 204, in the TTJA division of that Act under the Metrology Act heading; in force since 1 January 2019. The fee covers the grant, amendment or extension of the national type-approval certificate.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.riigiteataja.ee/akt/RLS
Source Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Source Effective Date
2025-01-01
Verified On
2026-09-16

Notes

Estonia has no national device authorisation, so there is no authorisation fee: the fee record consists of the State Fees Act charges for the acts Ravimiamet performs under the Medical Devices Act, plus the TTJA metrology type-approval fee.
Estonia's device fees are not differentiated by device risk class at all. The two bands are the reporter's grouping of the published amounts: the lower band collects the applicant-level charges (EUR 0 for the free notification and database registration, EUR 210 for a clinical-investigation review, EUR 154 or EUR 308 for a free-sale certificate, EUR 32 for a duplicate and EUR 240 for a metrology type approval); the upper band collects the two institutional designation charges (EUR 777 and EUR 2,590).
The Medical Devices Act allows Ravimiamet to charge for paid services and caps a single service fee at EUR 20,000 (§ 15¹(3)), with the list of services and the rates to be set by a regulation of the minister (§ 15¹(4)); that regulation was not retrieved, so no paid-service rate is published here.
Keskkonnaamet states that a state fee is payable for reviewing a radiation-activity licence or registration application, but neither that page nor any retrieved instrument publishes the amount, so radiation fees are absent from this record.
All amounts are net of value added tax as state fees.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Riigilõivuseadus (State Fees Act) — '4. jaotis: Meditsiiniseadme seaduse alusel tehtavad toimingud', §§ 28⁵³-28⁵⁵ (in force 01.01.2025, RT I, 20.11.2024, 1) and § 204 under '3. jaotis: Mõõteseaduse alusel tehtavad toimingud'
Url
https://www.riigiteataja.ee/akt/RLS
Effective Date
2025-01-01
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Estonia certifications →

Slug

estonia

Market

Estonia

Confidence

high

Schemes

Id
lvd-medical-exclusion-mdr-electrical-safety
Name
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Electrical Medical Equipment
Note
Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so no separate Estonian electrical-safety certificate exists for a medical device; electrical safety is assessed inside the MDR conformity assessment against MDR Annex I, with the harmonised IEC/EN 60601 series carrying the presumption of conformity. For radio equipment the same safety requirements are separately applied by the Estonian radio rule without any voltage limitation (§ 2(1)(2) of määrus nr 46). The Estonian instrument transposing the Low Voltage Directive for standalone equipment was not retrieved, so this row is bound to the Union directive.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Source Binding
candidate
Id
emc-directive-disapplied-by-mdr
Name
EMC Directive disapplied where MDR fixes the same essential requirements
Category
emc
Status
Included In Medical Registration
Object
Electrical Medical Equipment
Note
Article 2(3) of Directive 2014/30/EU switches the EMC Directive off where other Union legislation lays the same essential requirements down more specifically, which MDR Annex I sections 18.5 and 18.6 do for medical devices. EMC is therefore dossier evidence inside the CE route rather than a separate Estonian conformity step; where a device is also radio equipment, § 2(1)(3) of määrus nr 46 applies the EMC requirements directly and TTJA supervises them. The Estonian instrument transposing the EMC Directive for standalone equipment was not retrieved, so this row is bound to the Union directive.
Source Urls
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Source Binding
candidate
Id
ttja-radio-equipment-mandatory-requirements
Name
Radio-equipment essential requirements, conformity assessment and type registration (määrus nr 46)
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
Nõuded raadioseadmele ja nõuetele vastavuse tõendamise kord, adopted 04.07.2016 nr 46 by the Minister of Economic Affairs and Infrastructure, is the Estonian rule made under § 120²(3) of the Electronic Communications Act and § 5(4) of the Product Conformity Act. The current redaction (Kehtiv sõnastus 28.05.2026, last amended RT I, 24.04.2026, 3, in force 29.05.2026) sets the essential requirements in § 2 — safety of use, the Directive 2014/35/EU safety requirements applied without a minimum-voltage limit, and EMC per Directive 2014/30/EU — plus the efficient use of spectrum and the avoidance of radio interference in § 2(2). § 5 sets the conformity-assessment procedures (internal production control, EU type examination plus conformity to type, or full quality assurance, per Annexes 1 to 3), § 7 the CE marking and notified-body number, and § 8 the technical documentation. § 9(1)(9) makes failure to meet the type-registration requirement of § 120³ of the Electronic Communications Act a formal non-conformity, and § 10 designates the Tarbijakaitse ja Tehnilise Järelevalve Amet (TTJA) as market-surveillance authority. A medical device that is also radio equipment therefore carries these requirements in addition to the MDR route.
Source Urls
https://www.riigiteataja.ee/akt/106072016039?leiaKehtiv
Source Binding
reviewed
Id
ttja-legal-metrology-type-approval
Name
National type approval of a measuring instrument (TTJA) and the state fee for it
Category
Legal Metrology
Status
Mandatory If Feature
Object
Legal Measuring Instruments
Note
The state fee for reviewing an application for a national type-approval certificate for a measuring instrument (riigisisese tüübikinnitustunnistuse taotluse läbivaatamine) is EUR 240, set by § 204 of the State Fees Act. That section sits under '3. jaotis — Mõõteseaduse alusel tehtavad toimingud' within '6. jagu — Tarbijakaitse ja Tehnilise Järelevalve Ameti toimingud', so the measure is a TTJA action, and the metrology part of TTJA's own site carries the legal-metrology service under the same authority. A medical device that is a legal measuring instrument (for example a sphygmomanometer or a clinical thermometer used in a regulated measurement) therefore needs its own national type approval; the CE mark on a medical device does not discharge that duty. Only the type-approval fee was evidenced; the Metrology Act itself was not opened, so no article of it is cited.
Source Urls
https://www.riigiteataja.ee/akt/RLS
Source Binding
reviewed
Id
keskkonnaamet-ionizing-radiation-licence
Name
Keskkonnaamet radiation-activity licence or registration for electrical radiation devices
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Ionizing Radiation Sources And Electrical Radiation Devices
Note
Starting a radiation activity, or working in a radiation job requiring a radiation-activity licence or registration without one, is prohibited. Keskkonnaamet's page lists among the activities requiring a licence 'elektrikiirgusseadme kasutamiseks ja hoidmiseks', so an X-ray or accelerator-based medical device is in scope even though it contains no radioactive source; very-low-risk activities instead need a registration, and the page expressly lists intraoral dental X-ray units, bone densitometers, X-ray diffractometers and stationary fluoroscopy units among them. A licence decision is made within 90 days of receipt of a compliant application and documents, and for a high-risk radiation activity Keskkonnaamet may extend that period by up to 90 days; a registration decision is made within 30 days of receipt of a compliant application. Applications, reporting and the state fee are all handled through the environmental-decisions information system KOTKAS. The page states that a state fee is payable for reviewing a licence or registration application but publishes no amount.
Source Urls
https://keskkonnaamet.ee/keskkonnakasutus-kiirgus/kiirgus/kiirgustegevusluba-ja-kiirgustegevuse-registreering
Source Binding
reviewed
Id
keskkonnaamet-eee-producer-responsibility
Name
Producer responsibility for electrical and electronic equipment and batteries under the Waste Act
Category
Environmental And Batteries
Status
Mandatory Pre Market
Object
Electrical And Electronic Equipment And Batteries
Note
The Waste Act (Jäätmeseadus) places the waste-management duties for problem products on the producer: chapter 2 regulates 'Tootja, tootjate ühendus, turustaja ja volitatud esindaja' (§ 23) and the producer's self-monitoring system (§ 23¹), the producer's duties to prevent waste and to collect the waste arising (§ 24), a separate duty of the manufacturer of electrical and electronic equipment containing batteries and accumulators (§ 24¹), the producer's duties in handling waste from problem products (§ 26), the apportionment of the costs of collecting and returning waste electrical and electronic equipment to the producer (§ 26²), the costs of collecting and further treating used batteries and accumulators (§ 26⁶), the take-back duties of producers and distributors at the point of sale (§ 26⁷) and the duties of a distributor of electrical and electronic equipment (§ 26¹³). The duty is therefore a producer obligation attaching to placing electrical and electronic equipment on the Estonian market. Only the consolidated act's section structure was retrievable, not the article text, so this row is bound as a candidate and asserts no quoted article and no fee amount.
Source Urls
https://www.riigiteataja.ee/akt/103122025004
Source Binding
reviewed

Official Sources

Authority
Riigi Teataja
Topic
Nõuded raadioseadmele ja nõuetele vastavuse tõendamise kord (määrus nr 46 of 04.07.2016), current redaction 28.05.2026
Url
https://www.riigiteataja.ee/akt/106072016039?leiaKehtiv
Authority
Riigi Teataja
Topic
Riigilõivuseadus (State Fees Act), § 204 national measuring-instrument type approval and §§ 28⁵³-28⁵⁵ medical device procedures
Url
https://www.riigiteataja.ee/akt/RLS
Authority
EUR-Lex
Topic
Directive 2014/35/EU (Low Voltage Directive), Annex II medical exclusion
Url
https://eur-lex.europa.eu/eli/dir/2014/35/oj
Authority
EUR-Lex
Topic
Directive 2014/30/EU (EMC Directive), Article 2(3)
Url
https://eur-lex.europa.eu/eli/dir/2014/30/oj
Authority
Keskkonnaamet
Topic
radiation-activity licence and radiation-activity registration, including electrical radiation devices, decided through KOTKAS
Url
https://keskkonnaamet.ee/keskkonnakasutus-kiirgus/kiirgus/kiirgustegevusluba-ja-kiirgustegevuse-registreering
Authority
Riigi Teataja
Topic
Jäätmeseadus (Waste Act), consolidated text — producer responsibility for problem products including electrical and electronic equipment and batteries
Url
https://www.riigiteataja.ee/akt/103122025004

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Pricing

Advertising, claims & promotion

Medical device advertising in Estonia is governed by the general Advertising Act, and Ravimiamet supervises and prosecutes it

Approval validity & renewal

Free sale certificate for export

Transitional validity of MDD/AIMDD certificates

Authority & regime

Competent authority for medical devices

Supervision split between Ravimiamet and Terviseamet

Change control

No significant changes condition for transitional devices

Notification of significant changes to custom-made devices

Classification rules

Risk classification under MDR Annex VIII

Clinical investigation & performance

Estonia's national addition: Ravimiamet's authorisation for a sponsor not established in the EU to designate a contact person

Sponsor notification of low-intervention studies

Device definition & scope

Authority may qualify a product as a medical device

Dossier requirements

What the Estonian Medical Devices Act adds to the dossier: retention of the documents available to Ravimiamet for the MDR/IVDR periods

The device dossier in Estonia is the technical documentation of MDR/IVDR, applied directly

Economic-operator roles

Authorised representative required for non-EU manufacturers

National duty framework for operators

Establishment, import & distribution

Notification of first distribution in Estonia

Estonian medical devices and aids database (MSA)

Fees

Cap on Ravimiamet charges for paid services

Label, IFU & language

Language of the declaration of conformity and notified body certificates

Language of device information supplied with the device

Legal basis & guidance

National act governing medical devices

Manufacturer PMS

Manufacturer post-market surveillance system

Official forms & portals

Free sale certificate: the statutory rule for the application and the certificate

QMS, audit & inspection

Ravimiamet's state supervision over devices and the inspection measures it may use

What the Estonian act adds to the Union QMS route: notified-body oversight and Ravimiamet's competent-authority role

The quality-management-system duty and the conformity-assessment route for devices in Estonia are the Union ones, with the notified-body audit under MDR Annex IX

Recall, FSCA & market surveillance

Supervisory measures available to Ravimiamet

Registration pathways

Custom-made device notification

In-house manufactured devices listing

Reliance & recognition

Estonia approvals and evidence in other markets (0 records)

Prior approvals and evidence for Estonia (3 records)

CE marking under MDR/IVDR is the domestic route

FDA 510(k)/PMA

US FDA clearance: no recognition route into Estonia

Review clocks

Ravimiamet notifies its decision on a clinical-investigation or performance-study application in the procedure of the MDR/IVDR; the Act sets no separate national period

Special access & derogation

National derogation from conformity assessment

Standards, testing & ancillary approvals

Presumption of conformity from harmonised standards

Submission communications & appeal

Challenging a Ravimiamet act or measure: the general administrative-law remedy, since the Act's own challenge provision is repealed

UDI, listing & traceability

UDI system and device registration

Vigilance & incident reporting

Manufacturer duty to report serious incidents and field safety corrective actions

National incident registration and field safety notice language

Related structured datasets

More Estonia medical device resources