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ANMDMR · structured requirements

🇷🇴 Romania medical device regulatory data

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

59 facts23 dimensions16 official sourceslatest verification 2026-09-15

Advertising, claims & promotion

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

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ANMDMR competent authority for advertising approval

advertising.authority-scope
Fact-level verified

ANMDMR is the competent authority for evaluating, notifying and approving advertising materials and any other form of advertising for medical devices, except advertising aimed at healthcare professionals when the device is not on the high-population-health-risk list.

Conditions
  • The high-risk device list and its update criteria are set by ministerial order (Art. 18(2)).

For IVDs ANMDMR is competent for all advertising (Art. 14(2) OUG 137/2022).

ANMDMR enforcement of advertising rules

advertising.enforcement-and-corrective-declaration
Fact-level verified

ANMDMR analyses ex officio or on complaint breaches of the advertising chapter, orders cessation of already-published advertising or prohibition of unpublished advertising, and obliges the offender to publish a corrective declaration approved by ANMDMR on the same channel; fines of 10,000-20,000 lei apply (Art. 29(33)).

Conditions
  • Applies to advertising for medical devices.

Prior emergency notification for high-risk HCP advertising

advertising.hcp-high-risk-prior-notification
Fact-level verified

Advertising of a device on the high-population-health-risk list aimed at healthcare professionals must be notified in advance, in emergency regime, to ANMDMR by the manufacturer, importer or distributor.

Conditions
  • Triggered by the high-risk list issued under Art. 18(2) OUG 46/2021.

Ban on public advertising of special-purpose devices

advertising.public-ban-special-purpose
Fact-level verified

Public advertising is prohibited for devices with special purposes usable only on medical recommendation; public advertising is allowed only for devices intended to be used without intervention of qualified medical staff (pharmacist advice sufficing where needed).

Conditions
  • Content requirements for public advertising in Art. 20 OUG 46/2021.

Prior approval (viză de publicitate) for public advertising

advertising.public-pre-approval-viza
Fact-level verified

Documentation for advertising of a medical device aimed at the general public must be filed with ANMDMR by the manufacturer, importer or distributor for approval, and the advertising may be disseminated only after obtaining the advertising visa (viză de publicitate).

Conditions
  • Evaluation period 30 days from a complete dossier, extendable to maximum 60 days for complex cases (Art. 21(3),(5)).
  • Fee: 2,720 lei for advertising material (Ordin 3467/2022 item 4.1).

Approval validity & renewal

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

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Custom-made registration certificates valid 24 months after EUDAMED notice

validity.custom-made-certificate-transition
Fact-level verified

Custom-made registration certificates issued under the old Ordin 1009/2016 regime remain valid for 24 months from publication of the EU notice that EUDAMED has reached full functionality (MDR art. 34(3)).

Conditions
  • Applies only to certificates issued before OMS 2845/2022 entered into force.

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
Fact-level verified

ANMDMR (Agenția Națională a Medicamentului și a Dispozitivelor Medicale din România) is designated as the competent authority for medical devices and as the market surveillance authority in the field of medical devices.

Conditions
  • Applies to all medical device classes under MDR.
  • National designation on top of directly applicable MDR.

OUG 46/2021 is Romania's MDR-implementing emergency government ordinance, published in MOf. 588 of 11 June 2021.

Responsible authority for notified bodies

authority.notified-body-responsible-authority
Fact-level verified

ANMDMR is designated as the responsible authority for notified bodies (designation applications, monitoring, suspension or withdrawal of designation).

Conditions
  • Applies to conformity assessment bodies seeking notification in Romania.

Mirror rule for IVDs in Art. 15(1) OUG 137/2022.

Change control

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

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Duty to notify changes after national database registration

change.post-registration-update-duty
Fact-level verified

Persons who registered devices in the national database must communicate to ANMDMR any change occurring after receipt of the registration notice, including interruption/cessation of placing the registered devices on the market; ANMDMR updates the database and informs them within maximum 60 days.

Conditions
  • Name/address changes are updated based on the trade registry certificate (Art. 8(3)).
  • Fee for recording modifications: 350 lei (Ordin 3467/2022 item 1.10).

Custom-made equivalent: Art. 6 OMS 2845/2022.

Clinical investigation & performance

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

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National ethics opinion prerequisite for clinical investigations

clinical.ethics-committee-prerequisite
Fact-level verified

ANMDMR approves clinical investigation applications only if accompanied by the ethics opinion of the National Bioethics Commission for Medicines and Medical Devices (CNBMDM), whose composition and rules are approved by Order of the Minister of Health no. 80/2023.

Conditions
  • Legal bases cited by ANMDMR: MDR art. 61-82 and Annexes XIV-XV; OUG 46/2021 art. 16; Ordin 330/2023 (IVDR art. 56-77, OUG 137/2022).

Device definition & scope

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

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Any health evaluation or therapy deemed performed for medical purpose

scope.medical-purpose-deeming
Fact-level verified

Any form of health-state evaluation or therapy, even if the values obtained are informative, including in complementary-medicine or bioresonance cabinets, is deemed performed for a medical purpose and only medical devices may be used for it.

Conditions
  • Applies regardless of setting, including mobile provision of such activities.

National rule targeting bioresonance and similar borderline equipment.

National ban on reprocessing single-use devices

scope.sut-reprocessing-ban
Fact-level verified

Reprocessing of single-use devices and materials for reuse in public and private health institutions is prohibited, and use of reprocessed single-use devices in such institutions is prohibited.

Conditions
  • Romania uses the MDR art. 17 option to not allow reprocessing; ban applies inside health institutions.

Dossier requirements

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

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EU declaration of conformity translated

dossier.declaration-of-conformity-translation
Fact-level verified

The manufacturer's EU declaration of conformity is translated into Romanian or English (per MDR art. 19(1)); IVD equivalent in Art. 3(9) OUG 137/2022.

Conditions
  • Certificates issued by notified bodies established in Romania are also drafted in Romanian (Art. 3(6)).

Language of documentation submitted to ANMDMR on request

dossier.language-of-documentation
Fact-level verified

At ANMDMR's request, the manufacturer or authorised representative must transmit all information and documentation demonstrating conformity: drafted in Romanian for manufacturers established in Romania, or in English and translated into Romanian for manufacturers outside Romania.

Conditions
  • Applies when ANMDMR requests documentation.

Economic-operator roles

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

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Registration of relabelling/repacking operators

roles.relabel-repack-national-registration
Fact-level verified

Distributors or importators performing relabelling or repacking under MDR art. 16(2)(a)-(b) must inform ANMDMR when making the device available, attaching the Romanian-translated label/IFU; ANMDMR registers the economic operator in the national database with its translation/repacking activity and issues a confirmation letter (annex 8, form per annex 7, Ordin 3539/2022).

Conditions
  • Device must remain conformant with the Regulation.

Establishment, import & distribution

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

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Permit invoice payment rules and case closure

establishment.invoice-rules
Fact-level verified

The fiscal invoice is issued within maximum 90 days of filing the permit application (art. 10(1) Ordin 566/2020); failure to pay the invoice within the stated term leads to closure of the file; after two free re-evaluations, any new re-evaluation is charged at 50% of the initial fee.

Conditions
  • Applies to aviz de funcționare applications.

Operating permit (aviz de funcționare) for import, distribution, installation

establishment.operating-permit-activities
Fact-level verified

Marketing and service activities in the medical device field are subject to ANMDMR operating-permit control: (a) import of medical devices; (b) distribution of medical devices; (c) installation and/or maintenance of medical devices.

Conditions
  • Legal basis: art. 2 of the methodological norms for Title XX of Legea 95/2006 approved by OMS 566/2020.
  • Fees set by Ordin 3467/2022 items 5.1-5.2.

Label, IFU & language

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

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English-language exemption for HCP-only devices

language.english-hcp-exemption
Fact-level verified

The information may, for justified reasons, be supplied in English for devices intended exclusively for healthcare professionals, only with their written consent and based on an ANMDMR approval (aviz).

Conditions
  • Requires written consent of the professionals and ANMDMR aviz.
  • Procedure and 30-day decision in Art. 11 Ordin 3539/2022 (form annex 6).

IVD mirror: Art. 3(2) OUG 137/2022.

Translation exemption is time-limited and exceptional

language.exemption-scope-conditions
Fact-level verified

The exemption from Romanian translation is granted for a determined period only, in exceptional well-justified cases when no similar product exists on the market; ANMDMR validates or rejects the exemption request within maximum 30 days of registration, and the distributor/manufacturer must ensure training of the consenting professional receiving English-language information.

Conditions
  • Exemption procedure per Art. 11 and form F.4/annex 6 of Ordin 3539/2022; IVD equivalent in Ordin 3753/2023.

Implant card and patient information in Romanian

language.implant-card-romanian
Fact-level verified

Health institutions must provide implanted-patient information under MDR art. 18(1) together with the implant card, in Romanian and understandable by a lay person; excluded for sutures, staples, dental filling materials, braces, crowns, screws, wedges, wires, needles, clamps and connectors.

Conditions
  • Duty sits on public and private health institutions, not the manufacturer.

Romanian language mandatory for information accompanying the device

language.romanian-mandatory
Fact-level verified

Information supplied by the manufacturer with the medical device (MDR Annex I Chapter III point 23) must be presented mandatorily in Romanian, without excluding presentation in other official EU languages.

Conditions
  • Applies to labels and IFU.

IVD mirror: Art. 3(1) OUG 137/2022 (Annex I point 20).

User interface language rule

language.user-interface-romanian-for-lay-users
Fact-level verified

The user interface of equipment for healthcare professionals may, for justified reasons, be in English with the user's written consent; for equipment intended for lay users the interface must be in Romanian. For IVD self-tests the interface must be in Romanian.

Conditions
  • Self-test interface rule: Art. 3(3) OUG 137/2022.

Manufacturer PMS

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

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PMCF/PMPF study plan notification to ANMDMR

pms.pmcf-pmpf-study-notification
Fact-level verified

Sponsors must notify ANMDMR of PMCF study plans (MDR) and PMPF plans (IVDR); ANMDMR evaluates the notification documentation for a fee of 1,880 lei.

Conditions
  • Fee item 3.10, Annex 1 to Ordin 3467/2022 (base amounts of Nov 2022, indexed annually).

Official forms & portals

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

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Clinical investigation application form

forms.clinical-application-mdcg
Fact-level verified

The sponsor or authorised representative submits the clinical investigation application to ANMDMR using the application form in Annex 1 to MDCG 2021-8 (Commission document); submissions and SAE reporting go to dscdm@anm.ro.

Conditions
  • Application registered only with proof of fee payment (OMS 3467/2022).

EUDAMED actor registration validated by ANMDMR (SRN)

forms.eudamed-actor-validation
Fact-level verified

ANMDMR verifies data entered by manufacturers, authorised representatives and importers in EUDAMED, obtains the Single Registration Number from the system and transmits it; per the ANMDMR page it validates, rejects or requests corrections, and a separate registration with different SRN applies per role.

Conditions
  • Fee: 220 lei per EUDAMED validation (Ordin 3467/2022 item 1.12).
  • EUDAMED mandatory use per Decision (EU) 2025/2371 from 28 May 2026.

IVD mirror: Art. 9 OUG 137/2022.

QMS, audit & inspection

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

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Manufacturer quality management system (Art. 10(9))

qms.manufacturer-qms-art-10-9
Fact-level verified

Manufacturers must 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; the system covers design and manufacture through final inspection and is assessed by the notified body as part of conformity assessment (Annex IX Chapter I).

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

Recall, FSCA & market surveillance

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

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Registration pathways

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

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National registration of custom-made devices

registration.custom-made-devices
Fact-level verified

A Romanian-established manufacturer placing custom-made devices on the market under its own name must register at ANMDMR with registered-office address and description of the devices, under the norms approved by OMS 2845/2022 (applying art. 13 OUG 46/2021).

Conditions
  • Notification form F.CMD with documents depending on device class.

Filing channel for national database registration

registration.filing-channel
Fact-level verified

Registration filings are made by email or in person at ANMDMR: the payment form to registratura@anm.ro (or at the headquarters), and the registration request after payment confirmation to drsp@anm.ro; address Strada Aviator Maior Ștefan Sănătescu 48, Sector 1, Bucharest.

Conditions
  • Fee must be paid before the request is registered (Ordin 3467/2022 art. 2(2)).

National database registration for IVDs

registration.national-database-ivd
Fact-level verified

The Romanian-established producer or authorised representative placing IVDs on the market under its own name must register at ANMDMR, for IVD classes A, B, C and D, using the notification form of annex 1 to Ordin 3753/2023.

Conditions
  • Registration made in accordance with art. 29 HG 798/2003 as amended.
  • ANMDMR may additionally request technical documents.

National database registration for medical devices

registration.national-database-md
Fact-level verified

Romanian-established manufacturers placing devices on the market under their own name (including systems and procedure packs under MDR art. 21(2)) must register at ANMDMR, giving registered-office address and device description, for entry in the national device database (baza națională de date). Per the ANMDMR page this covers classes I, IIa, IIb and III, including sterile and/or measuring devices.

Conditions
  • Applies to producers or authorised representatives established in Romania.
  • Procedural norms: art. 6 Ordin 3539/2022 (notification form).
  • Sanction for non-registration: 2,000-5,000 lei (Art. 29(31) OUG 46/2021).

Parallel EU-level obligation is EUDAMED actor registration; this is the additional national listing.

Reliance & recognition

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

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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.

Romania 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 Romania (3 records)

RomaniaEU conformity assessment

Prior approval / evidence record

EU CE under MDR/IVDR — single market validity

reliance.reliance-edge-eu-ce-to-eea30-approval-eu-ce-mdr-ivdr-romania
Fact-level verified
Target

geo:rou

Source Approval

EU CE under MDR/IVDR

Edge Type

Single Market Validity

Market Access Strength

direct

Regulatory Layer

Product Marketing

Same Device Required

Yes

Local Application Required

No

Target Decision Retained

No

Conditions
  • medical devices and IVDs subject to route-specific scope
  • valid CE conformity route for the device
  • Romanian language duties under OUG 46/2021 for devices and OUG 137/2022 for IVDs, registration in the national database, EUDAMED actor registration and the ANMDMR vigilance channel still apply

Ordonanța de urgență nr. 46/2021 implements MDR and OUG nr. 137/2022 implements IVDR. Both designate the competent authority, set the Romanian language rules and require entry in the national database; neither creates a Romanian conformity decision.

RomaniaUS 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

Commission Implementing Regulation (EU) 2026/977, Art. 2 — maximum notified-body conformity assessment timelines (30 + 120/90 parallel + 20 days)EUR-Lex Regulation (EU) 2017/745 (MDR)EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

RomaniaNMPA

Regulatory reference

NMPA certificate does not replace EU conformity assessment

reliance.china-nmpa-no-recognition-route
Fact-level verified
Statement

For ordinary market placement under MDR/IVDR, a Chinese approval does not replace conformity assessment under MDR Article 52 or IVDR Article 48. The applicable EU class and procedure must be established independently; lower-risk devices may self-declare, while other devices require notified-body assessment. This is a finding about the ordinary conformity route, not a ban on Chinese devices or their technical evidence.

Source Jurisdiction Id

china

Source Authority Id

nmpa

Source Approval

China NMPA medical device registration certificate (Class II/III) or Class I filing record

Target Jurisdiction Id

romania

China Classes In Scope

All NMPA classes (I filing, II, III) -> all EU MDR/IVDR classes

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Product Marketing

Local Application Required

null

Target Decision Retained

null

Conditions
  • Determine the local class independently; NMPA Class III is not an automatic EU class assignment.
  • A local regulatory application/decision is not universal: MDR Article 52(7) and IVDR Article 48(10) permit specified self-declaration routes.
  • Clinical, performance and technical evidence must meet the applicable EU requirements; the certificate alone does not replace them.
  • Special-purpose, investigational, custom-made and derogation regimes require separate assessment.
MDR consolidated text, 19 July 2026IVDR consolidated text, 10 January 2025

Independent review of current EUR-Lex consolidations supports this bounded ordinary-route conclusion. It does not establish the absence of every special route.

Review clocks

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

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Clinical investigation review clock (Art. 70(7))

review.clinical-investigation-clock-art-70-7
Fact-level verified

For clinical investigation applications, the member state must notify the sponsor of the authorisation decision within 45 days of the validation date (Art. 70(5)), extendable by a further 20 days for the purpose of consulting with experts; once notified, and absent a negative ethics opinion valid for the entire member state, the sponsor may start the investigation with the devices referred to in the application.

Conditions
  • EU-wide rule under Regulation (EU) 2017/745, which applies directly in the member state; national implementing or administrative details are not covered by this fact.

Effective from 2021-05-26

The fixed statutory clock in the MDR is the clinical-investigation authorisation clock; no statutory review deadline is fixed for notified-body conformity assessment itself.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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National derogation for IVDs under IVDR art. 54

derogation.ivd-art-54
Fact-level verified

Under IVDR art. 54, ANMDMR may authorise, on a duly justified request, placing on the market or putting into service in Romania of an IVD for which the relevant procedures have not been carried out, where use is in the interest of public health or of patient safety or health.

Conditions
  • Methodological norms to be approved by ministerial order (Art. 8(2) OUG 137/2022).

National derogation under MDR art. 59(1)

derogation.national-mdr-59
Fact-level verified

ANMDMR may authorise, on request, placing on the market or putting into service in Romania of devices for which the conformity procedures of MDR art. 59(1) have not been carried out, in well-founded public-health or patient-safety interest (e.g. epidemics, health crises, unavailability of an equivalent device); the national derogation is valid maximum 6 months, extendable, and the request is validated or rejected within maximum 30 days.

Conditions
  • No obligation to inform the Commission and member states when the authorisation is for a device intended for a single patient (Art. 9(4) Ordin 3539/2022).

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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Periodic in-use verification duty for health units

ancillary.in-use-periodic-verification-duty
Fact-level verified

Health units must ensure periodic verification of medical devices in use as required by law (Legea 95/2006 art. 933(1)(h)); Ordin 2219/2022 sets the devices subject to control and verification periodicity in its annex 1, requires a responsible person and register of devices in use (art. 20), and prohibits use of devices that fail the tests (art. 21(1)).

Conditions
  • Verification tests carried out against ANMDMR fees (Ordin 3467/2022 items 6.1-6.12).
  • Use authorisation (aviz de utilizare) issued after failed-check re-verification (art. 21(2)).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

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Contestation of ANMDMR clinical investigation decisions

appeal.clinical-contestation
Fact-level verified

Authorisations, rejection decisions and suspensions for clinical investigations can be contested by the sponsor at ANMDMR within 30 days of receipt; a contestation commission (minimum 3 members not involved in the evaluation) meets within maximum 30 days, and the ANMDMR president's decision is communicated within maximum 7 days of the session; further appeal lies to the competent administrative courts.

Conditions
  • Procedure per Art. 25 Ordin 330/2023.

Deficiency completion deadlines in clinical investigation validation

appeal.deficiency-response-deadlines
Fact-level verified

If the clinical investigation dossier is incomplete or out of scope, ANMDMR sets a maximum 10-day term for the sponsor to transmit completions, extendable by maximum 20 days for complex information; failure to complete in time makes the request caduc (lapsed) without a separate decision; rejection decisions are communicated within maximum 5 days.

Conditions
  • Validation itself notified within 10 days of receipt (Art. 4(10)); each term extendable by 5 days per MDR art. 70(4).

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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Health institutions must store UDI of implantables electronically

udi.hospital-electronic-storage-implantables
Fact-level verified

Public and private health institutions in Romania must store and keep, in electronic format, the UDI of implantable medical devices they supplied or which were supplied to them.

Conditions
  • Excludes custom-made and investigational devices (Art. 8(1)).
  • Fine for breach: 5,000-10,000 lei (Art. 29(30) OUG 46/2021).

UDI storage obligations for IVDs

udi.ivd-storage-obligations
Fact-level verified

Economic operators must electronically store and keep the UDI of IVDs supplied to and by them once the Commission adopts the implementing act (IVDR art. 24(8), (11)(a)); public and private health institutions must likewise store the UDI of such IVDs supplied to them.

Conditions
  • Excludes devices covered by performance studies (Art. 6(1)).

Official UDI and listing surfaces

udi.official-listing-surface
Fact-level verified
Submission Surface

EUDAMED (actor and device registration, UDI database) validated by ANMDMR, plus the Romanian national device database (baza națională de date) with public search on anm.ro

Verified Highlights
  • ANMDMR verifies EUDAMED data, validates/rejects actor registration and transmits the SRN.
  • Registered data are stored in the national device database per Art. 14 OUG 46/2021.
Conditions
  • EUDAMED mandatory use applies from 28 May 2026 per Decision (EU) 2025/2371.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

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10-day authority disagreement window on trend/rationale reports

vigilance.authority-disagreement-10-days
Fact-level verified

For medical devices, within maximum 10 days of receiving the rationale under MDR art. 87(11) third paragraph, ANMDMR informs the manufacturer if it disagrees with the conclusion and may require a report under art. 87(1)-(5) and that appropriate actions be taken; equivalent 10-day rule for IVDs under IVDR art. 82(11).

Conditions
  • Procedure per Ordin 2882/2021; amended by OMS 3876/2023 art. I per ANMDMR vigilance page.

Field safety notice in English and Romanian

vigilance.fsn-bilingual
Fact-level verified

The field safety notice under MDR art. 89(8) must be drafted in both English and Romanian and made available without delay to users of the device; for devices used exclusively by healthcare professionals, at their request it may be provided in English only.

Conditions
  • IVDR mirror: Art. 7(7)-(8) OUG 137/2022 (art. 84(8)).

15-day national reporting by professionals, patients and users

vigilance.hcp-patient-15-days
Fact-level verified

Healthcare professionals, patients and users must report to ANMDMR any suspected serious incident with devices or IVDs they handle, within maximum 15 days from the date the incident occurred, depending on its consequences, using the national form; reports go to mdevice@anm.ro or by post.

Conditions
  • National form approved by ministerial order (Ordin 2882/2021); channel per ANMDMR vigilance page.

Health institutions report incidents with in-house devices

vigilance.in-house-device-incidents
Fact-level verified

Public and private health institutions in Romania must report to ANMDMR serious incidents involving use of devices manufactured in-house for their own use, and the corrective measures taken.

Conditions
  • Complements the MDR art. 5(5) in-house regime.

IVD mirror: Art. 7(5) OUG 137/2022.

Centralised IVD vigilance reporting

vigilance.ivd-manufacturer-reporting
Fact-level verified

ANMDMR centrally registers at national level every report by IVD manufacturers (other than performance-study devices) of serious incidents and field safety corrective actions; manufacturers report serious incidents respecting the IVDR art. 82 deadlines, using the Commission-provided forms.

Conditions
  • Applicable acts per ANMDMR vigilance page: IVDR art. 82-87, OUG 137/2022 art. 7, OMS 3876/2023 art. I.

Centralised national registration of manufacturer vigilance reports

vigilance.manufacturer-centralized-reporting
Fact-level verified

ANMDMR centrally registers at national level every report by manufacturers (other than investigational devices) of serious incidents and field safety corrective actions; manufacturers report serious incidents to ANMDMR respecting the MDR art. 87 deadlines, using the forms made available by the European Commission (MIR).

Conditions
  • Applies to incidents occurring on Romanian territory or FSCAs undertaken there.

Related structured datasets

Classification systems · 1 record
Open EU MDR classes I, Is, Im, Ir, IIa, IIb and III →
Id

romania:medical-device

Jurisdiction Id

romania

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; national references describe only administration or local deltas.

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

ANMDM

Official Domains
  • anmdm.ro
  • eur-lex.europa.eu
  • europa.eu
Source Status

official-source-verified

Reference Sources
  • Title

    Anexa 1, items 1.4-1.6, Ordin 3467/2022

    Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Reviewed On

    2026-08-25

    Supports

    Device classification follows MDR Annex VIII directly (no national classification rules); national delta is a paid ANMDMR classification opinion service: standard classification of one product 2,840 lei; classification contestation 2,840 lei; complex borderline-product classification 4,740 lei.

  • Title

    Art. 1(2) OUG 46/2021 (terms take the meaning of the Regulation)

    Url

    https://legislatie.just.ro/Public/DetaliiDocumentAfis/243191

    Reviewed On

    2026-08-25

    Supports

    For IVDs classification follows IVDR classes A-D directly; no national classification scheme located beyond the EU rules.

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

2026-08-26

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Romania registration →
Country

Romania

Jurisdiction Id

romania

Country Code

RO

Flag

🇷🇴

Regulator

National Agency for Medicines and Medical Devices

Regulator Abbrev

ANMDMR

Region

europe

Tier

3

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

    2026-08-25

    Realistic Timeline
    Min

    6

    Max

    9

    Unit

    months

    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, which has no guaranteed processing time, plus any national registration duty
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Key Requirements
  • EU Authorized Representative (for non-EU manufacturers)
  • Economic-operator registration (EUDAMED transitional): decision within 60 days; actor ID issued within 15 days of EUDAMED reactivation
  • Translation exemptions/derogations handled within 30 days
  • Clinical investigation: submission validation 10 days, applicant clarification 10 days, re-validation 5 days (aligned with MDR Art. 70)
  • Advertising: acknowledgement within 30 days, final decision within 60 days
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

Local Rep Required

Yes

Local Rep Name

EU Authorized Representative

Mdsap Accepted

No

Mdsap Benefit

ISO 13485 accepted as QMS evidence

Registration Validity

5 years (CE certificate)

Last Updated

2026-08-29

Verification Status

partially-verified

Official Sources
  • 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

    2026-08-29

  • Title

    EUR-Lex Regulation (EU) 2017/745 (MDR)

    Url

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

    Accessed Date

    2026-08-25

  • Title

    EUR-Lex MDR consolidated text — Annex IX §5.1 (expert-panel clinical evaluation consultation: 21/60 days) and §5.2(d) (ancillary medicinal-substance opinion: 210 days)

    Url

    https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02017R0745-20250110

    Accessed Date

    2026-08-29

Reviewed On

2026-08-29

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 ANMDMR. Appoint a EU Authorized Representative.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to ANMDMR including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    ANMDMR 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. ANMDMR may issue questions.

    Duration

    0 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, ANMDMR issues Romania market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Romania fees →
Jurisdiction Id

romania

Country

Romania

Country Code

RO

Authority

ANMDMR

Low Risk Local
Min

120

Max

120

Currency

RON

Per Product

No

High Risk Local
Min

20450

Max

20450

Currency

RON

Per Product

No

Details
  • Id

    customs-aviz

    Item

    Customs aviz (import authorisation)

    Currency

    RON

    Amount Local

    120

    Amount Local Formatted

    RON 120

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    free-sale-certificate

    Item

    Free-sale certificate

    Currency

    RON

    Amount Local

    1240

    Amount Local Formatted

    RON 1,240

    Frequency

    Per certificate (1–10 articles)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    national-database-registration-certificate

    Item

    National database registration certificate

    Currency

    RON

    Amount Local

    1310

    Amount Local Formatted

    RON 1,310

    Frequency

    Per certificate (max 5 products)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    in-house-device-notification

    Item

    In-house device notification dossier

    Currency

    RON

    Amount Local

    1310

    Amount Local Formatted

    RON 1,310

    Frequency

    Per product

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    database-modification

    Item

    Database modification

    Currency

    RON

    Amount Local

    350

    Amount Local Formatted

    RON 350

    Frequency

    Per modification (max 5 products)

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    database-search

    Item

    Database search

    Currency

    RON

    Amount Local

    220

    Amount Local Formatted

    RON 220

    Frequency

    Per search

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    eudamed-validation

    Item

    EUDAMED registration validation

    Currency

    RON

    Amount Local

    220

    Amount Local Formatted

    RON 220

    Frequency

    Per validation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    ci-authorisation-class-iii-iib-invasive

    Item

    Clinical-investigation authorisation - Class III / IIb invasive / implantable / Annex XVI

    Currency

    RON

    Amount Local

    20450

    Amount Local Formatted

    RON 20,450

    Frequency

    Per authorisation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    ci-validation-iia-iib

    Item

    Clinical-investigation validation - Class IIa–IIb non-invasive

    Currency

    RON

    Amount Local

    18030

    Amount Local Formatted

    RON 18,030

    Frequency

    Per validation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    ci-validation-i-iia

    Item

    Clinical-investigation validation - Class I–IIa non-invasive

    Currency

    RON

    Amount Local

    8770

    Amount Local Formatted

    RON 8,770

    Frequency

    Per validation

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    ci-substantial-technical-amendment

    Item

    CI/performance-study substantial or technical amendment

    Currency

    RON

    Amount Local

    5930

    Amount Local Formatted

    RON 5,930

    Frequency

    Per amendment

    Notes

    Administrative amendments: RON 2,620; resubmission after withdrawal/rejection: RON 6,780.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    ivd-performance-authorisation-self-cd

    Item

    IVD performance-study authorisation - self-test and Class C/D

    Currency

    RON

    Amount Local

    13710

    Amount Local Formatted

    RON 13,710

    Frequency

    Per authorisation

    Notes

    Class A/B: RON 11,200; leftover-specimen studies (IVDR art. 58(2)): RON 6,080.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    pmcf-pmpf-notification

    Item

    PMCF/PMPF notification evaluation

    Currency

    RON

    Amount Local

    1880

    Amount Local Formatted

    RON 1,880

    Frequency

    Per notification

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    advertising-material-approval

    Item

    Advertising material avizare

    Currency

    RON

    Amount Local

    2720

    Amount Local Formatted

    RON 2,720

    Frequency

    Per material

    Notes

    Educational material: RON 1,730.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    import-distribution-aviz

    Item

    Import/distribution operating aviz

    Currency

    RON

    Amount Local

    2620

    Amount Local Min

    1480

    Amount Local Max

    2620

    Amount Local Formatted

    RON 1,480–2,620

    Frequency

    Per aviz

    Notes

    Tiered by number of producers: 1,480 / 1,790 / 2,060 / 2,320 / 2,620 for 1–10 / 11–30 / 31–50 / 51–100 / over 100.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    installation-maintenance-aviz

    Item

    Installation/maintenance operating aviz

    Currency

    RON

    Amount Local

    2320

    Amount Local Min

    1660

    Amount Local Max

    2320

    Amount Local Formatted

    RON 1,660–2,320

    Frequency

    Per aviz

    Notes

    Tiered by number of device groups; additional work point: RON 990; name/address change: RON 330; permit/annex issuance: RON 310.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

  • Id

    notified-body-designation

    Item

    Notified-body designation

    Currency

    RON

    Amount Local

    40800

    Amount Local Formatted

    RON 40,800

    Frequency

    Per designation

    Notes

    Scope extension: RON 24,970; annual surveillance: RON 24,150.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Source Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Source Effective Date

    2022-11-01

    Verified On

    2026-08-25

Notes
  • Tariffs follow Ordin 3467/2022 Annex 1 (lei, base November 2022) and are indexed annually by 31 January from 2024.
  • Fees are payable before the request is registered; non-payment or incomplete payment (30-day completion window) causes rejection, and fees are not refunded for rejected requests.
  • A second activity is charged at 50%.
Last Updated

2026-08-25

Verification Status

official-verified

Official Sources
  • Title

    Romania ANM Order 3467/2022: device tariff Annex 1

    Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

    Effective Date

    2022-11-01

    Accessed Date

    2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Romania certifications →
Slug

romania

Market

Romania

Confidence

high

Schemes
  • Id

    lvd-medical-exclusion-mdr-electrical-safety

    Name

    MDR electrical safety in place of the Low Voltage Directive

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Annex II of Directive 2014/35/EU places electrical equipment for radiology and medical purposes outside the Low Voltage Directive, so there is no separate national electrical-safety certificate 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.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/35/oj
    Source Binding

    candidate

  • Id

    emc-directive-disapplied-by-mdr

    Name

    MDR electromagnetic compatibility in place of the EMC Directive

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    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 and not a separate national EMC conformity step.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2014/30/oj
    Source Binding

    candidate

  • Id

    hg-740-2016-radio-market-access

    Name

    HG 740/2016 radio equipment market access

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Article 6(1) of Hotărârea Guvernului 740 of 5 October 2016 permits making available on the market, putting into service and using only radio equipment that, when correctly installed, maintained and used as intended, meets the requirements of the decree — so compliance with the RED route is the sole condition and there is no Romanian type approval. The only registration duty in the decree is the article 5 Union-level registration for low-compliance categories under RED article 5. Article 23(4) puts market surveillance with ANCOM and ANPC.

    Source Urls
    • https://legislatie.just.ro/Public/DetaliiDocumentAfis/182813
    Source Binding

    candidate

  • Id

    anmdmr-in-use-verification-tests

    Name

    ANMDMR in-use verification tests

    Category

    Medical Electrical Safety

    Status

    Mandatory For Use Site

    Object

    Electromedical Device In Use

    Note

    Ordin 3467/2022 Annex 1 items 6.1-6.12 charge in-use verification: electrosecurity tests for electromedical devices 250 lei, performance tests 180 lei, CNCAN acceptability-criteria tests 1,000 lei, CNCAN use authorisation/re-authorisation 30% of base tariff, use-authorisation issuance 20 lei. Periodic in-use verification scope and periodicity are set in Annex 1 to Ordin 2219/2022; health units must keep a designated responsible person and a register of devices in use (Art. 20); devices failing the tests may not be used (Art. 21(1); Legea 95/2006 arts. 931-933).

    Source Urls
    • https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf
    Source Binding

    candidate

  • Id

    hg-322-2013-rohs

    Name

    HG 322/2013 restricting hazardous substances in electrical equipment

    Category

    Environmental And Batteries

    Status

    Evidence Only No Separate Certificate

    Object

    Electrical Electronic Medical Device

    Note

    HOTĂRÂRE nr. 322 of 29 May 2013, Monitorul Oficial nr. 348 of 13 June 2013, transposes Directive 2011/65/EU. Article 2(1) applies the decision to the Annex 1 categories, and Annex 1 category 8 is dispozitive medicale. Article 2(4)(h) (as numbered in the published text) keeps active implantable devices out. Article 4(3) is the date that matters for a device manufacturer: the substance restriction applies to medical devices and monitoring and control instruments placed on the market from 22 July 2014, to in vitro diagnostic medical devices from 22 July 2016 and to industrial monitoring and control instruments from 22 July 2017; article 4(4) then leaves devices placed on the market before those dates, and their repair spare parts, outside the restriction. There is no Romanian RoHS certificate sitting next to the CE marking. Directive 2011/65/EU Annex I category 8 covers medical devices, Article 4(3) has bound medical devices since 22 July 2014 and in vitro diagnostic medical devices since 22 July 2016, and Article 2(4)(h) excludes active implantable medical devices.

    Source Urls
    • https://legislatie.just.ro/Public/DetaliiDocumentAfis/148892
    Source Binding

    candidate

  • Id

    oug-5-2015-weee-national-producer-register

    Name

    OUG 5/2015 national WEEE producer register as a condition of placing on the market

    Category

    Environmental And Batteries

    Status

    Mandatory Pre Market

    Object

    Producer Or Authorised Representative

    Note

    ORDONANȚĂ DE URGENȚĂ nr. 5 of 2 April 2015, Monitorul Oficial nr. 253 of 16 April 2015. Article 38(1) has the Agenția Națională pentru Protecția Mediului keep a national producer register that includes distance sellers. Article 38(2) is the gate: in order to place EEE on the market, producers must enrol in that register and receive a registration number which they then communicate to every commercial network through which the equipment is sold. Distance sellers into Romania who are not themselves registered enrol through an authorised representative under article 38(4) and article 40(2). Medical devices are inside the open scope: Annex 1 category 8 is dispozitive medicale, with the usual exclusion of implanted and infective products, and article 5(g) repeats the Directive 2012/19/EU exclusion for devices expected to be infective before end of life and for active implantable devices. Directive 2012/19/EU Article 2(4)(g) excludes devices expected to be infective before end of life and active implantable devices; other medical devices are in scope, and Article 16 requires each Member State to keep a producer register.

    Source Urls
    • https://eur-lex.europa.eu/eli/dir/2012/19/oj
    Source Binding

    candidate

  • Id

    hg-1132-2008-battery-producer-register-still-on-2006-66

    Name

    HG 1.132/2008 battery producer register, not yet adapted to Regulation (EU) 2023/1542

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Battery Producer Or Authorised Representative

    Note

    HOTĂRÂRE nr. 1.132 of 18 September 2008, in the form last amended by HG 540/2016. Article 6(3) allows batteries and accumulators to be placed on the market only by producers entered in the Registrul național al producătorilor și importatorilor de baterii și acumulatori, kept by the environment ministry through the Agenția Națională pentru Protecția Mediului, and article 6(4) points the enrolment procedure to Annex 4. A full-text search of that consolidated expression contains no occurrence of '2023/1542', so the national decision still sits on the repealed Directive 2006/66/EC and no Article 55 designation appears in it; the Regulation applies directly in the meantime, which is the same split already recorded for Bulgaria and the Czech Republic and the opposite of Slovenia. Article 11(2)(b) of Regulation (EU) 2023/1542 lets professional medical imaging and radiotherapy devices and in vitro diagnostic medical devices restrict portable-battery replacement to independent professionals, and Article 11(3) lifts the removability duty where continuity of supply is needed for safety or data integrity.

    Source Urls
    • https://eur-lex.europa.eu/eli/reg/2023/1542/oj
    • https://legislatie.just.ro/Public/DetaliiDocumentAfis/226425
    Source Binding

    candidate

Official Sources
  • Authority

    EUR-Lex

    Topic

    Low Voltage Directive 2014/35/EU Annex II — electrical equipment for radiology and medical purposes outside scope

    Url

    https://eur-lex.europa.eu/eli/dir/2014/35/oj

  • Authority

    EUR-Lex

    Topic

    EMC Directive 2014/30/EU Article 2(3) — more specific Union legislation displaces the directive

    Url

    https://eur-lex.europa.eu/eli/dir/2014/30/oj

  • Authority

    EUR-Lex

    Topic

    RoHS Directive 2011/65/EU Annex I category 8 and Article 4(3) medical-device application dates

    Url

    https://eur-lex.europa.eu/eli/dir/2011/65/oj

  • Authority

    EUR-Lex

    Topic

    WEEE Directive 2012/19/EU Article 2(4)(g) medical-device exclusions and Article 16 national producer register

    Url

    https://eur-lex.europa.eu/eli/dir/2012/19/oj

  • Authority

    EUR-Lex

    Topic

    Batteries Regulation (EU) 2023/1542 Articles 11 and 55 — medical-device removability derogation and producer register

    Url

    https://eur-lex.europa.eu/eli/reg/2023/1542/oj

  • Authority

    Portalul legislativ (Ministerul Justiţiei)

    Topic

    HG 740/2016 arts. 6 and 23 — radio equipment market access and ANCOM/ANPC surveillance

    Url

    https://legislatie.just.ro/Public/DetaliiDocumentAfis/182813

  • Authority

    ANMDMR

    Topic

    Ordin 3467/2022 Annex 1 — in-use device verification test fees including CNCAN

    Url

    https://www.anm.ro/_/DM/LEGISLATIE/Ordin%203467-2022.pdf

  • Authority

    ANMDMR

    Topic

    supraveghere în utilizare — Ordin 2219/2022 periodic verification scope

    Url

    https://www.anm.ro/dispozitive-medicale/supraveghere-in-utilizare/

  • Authority

    Portal Legislativ (legislatie.just.ro)

    Topic

    HG 322/2013 — articles 2 and 4 and Annex 1 category 8

    Url

    https://legislatie.just.ro/Public/DetaliiDocumentAfis/148892

  • Authority

    Portal Legislativ (legislatie.just.ro)

    Topic

    OUG 5/2015 — articles 5(g) and 38 and Annex 1 category 8

    Url

    https://legislatie.just.ro/Public/DetaliiDocumentAfis/167211

  • Authority

    Portal Legislativ (legislatie.just.ro)

    Topic

    HG 1.132/2008 as amended by HG 540/2016 — article 6(3)–(4) battery producer register

    Url

    https://legislatie.just.ro/Public/DetaliiDocumentAfis/226425

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