Fimea · Europe

Finland medical device regulatory resources

Every Finland dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 requirements coveredAug 2026 fees reviewed

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Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Finland requirements.

Medical device regulation news

Follow recent Finnish Medicines Agency (Fimea) policy, guidance, safety, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary Fimea risk class with official rule references.

Government registration fees

Review current Fimea application, review, and renewal fees.

Registration timeline

Compare the statutory notified-body conformity assessment clock under Regulation (EU) 2026/977 with realistic CE marking times by device class.

Structured regulatory requirements

Explore all 47 source-linked facts →

24 of 25 research dimensions currently covered · 17 official sources · latest verification 2026-09-07

Market entry

D01

Authority & regime

Verified

Competent authority: Fimea (Finnish Medicines Agency, Lääkealan turvallisuus ja kehittämiskeskus) holds general steering and supervision of medical device activities in Finland; it is the competent authority un…
Radiation-safety authority split: STUK (Radiation and Nuclear Safety Authority, Säteilyturvakeskus) supervises compliance with Radiation Act requirements on population exposure to non ionizing radiation in medical devices;…

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

National implementation act: Laki lääkinnällisistä laitteista (719/2021) is the Finnish act giving national effect to MDR (EU) 2017/745 and IVDR (EU) 2017/746; it entered into force on 19 July 2021 and applies to IVD s…
Legacy device law: Devices under IVDD (98/79/EC) are governed by the Act on certain medical devices prescribed in EU directives (629/2010, formerly the Act on health care devices and supplies); that act also…

2 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Accessories and Annex XVI products covered: The national act's device rules apply also to accessories and, unless the MDR provides otherwise, to Annex XVI products within MDR scope; key operator/user provisions also apply to AIMDD/MD…
Single-use device reprocessing prohibited: Reprocessing and reuse of single use devices is prohibited in Finland — stricter than MDR Art. 17, which allows Member States to permit reprocessing under conditions.

2 source-linked facts

Checked 2026-08-25

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D04

Classification rules

Verified

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

1 maintained scheme

Checked 2026-08-26

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D05

Registration pathways

Verified

Market-access route or official registration surface: Operators established in Finland (manufacturers, custom made device manufacturers, system/procedure pack assemblers, sterilisation service providers, authorised representatives, importers)…
National notification until EUDAMED operational: For MDR/IVDR manufacturers and importers, the national notification duty (49 § 1–2 mom) applies until the European database (EUDAMED) is functional and the operator has registered itself an…

5 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

EU CE under MDR/IVDR — single market validity: target: geo:fin · sourceApproval: EU CE under MDR/IVDR · edgeType: single market validity · marketAccessStrength: direct · regulatoryLayer: product marketing · sameDeviceRequired: Yes · loc…

1 source-linked fact

Checked 2026-08-30

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D07

Economic-operator roles

Verified

PRRC national qualification power: Fimea may issue regulations on national professional qualification requirements for the person responsible for regulatory compliance (PRRC) under MDR Art. 15(1) and (6) and IVDR Art. 15(1)…
Installer and maintainer duties: Anyone professionally installing or servicing medical devices must follow the manufacturer's instructions on transport, storage, installation, maintenance, information security, updates and…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Legacy devices: importer/AR/distributor duties: Importer and authorised representative obligations under MDR/IVDR apply also when placing legacy AIMDD/MDD/IVDD compliant devices on the market under MDR Art. 120(3)/IVDR Art. 110(3); distr…

1 source-linked fact

Checked 2026-08-25

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D09

Dossier requirements

Verified

Notification content requirements: Notifications to Fimea must include the operator's name, place of business and other necessary contact details; manufacturers, custom made device manufacturers and importers must list the d…

1 source-linked fact

Checked 2026-08-25

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D10

Official forms & portals

Verified

CERE / EUDAMED registration portals: Operator and device notifications are made either into the national CERE register via Fimea e services (sähköinen asiointi) or into EUDAMED for Finland established operators (manufacturer,…

1 source-linked fact

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Safety information in Finnish and Swedish: Information and documents under MDR Art. 10(11)/IVDR Art. 10(10) must be in Finnish, Swedish or English unless given as internationally recognised symbols; however, information required for…
Consumer devices: bilingual IFU: If the device is intended for use by patients or otherwise by consumers, the instructions for use and other information required for safe use must be in Finnish and Swedish.

4 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

Manufacturer quality management system (Art. 10(9)): 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 effe…

1 source-linked fact

Checked 2026-08-29

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D13

Standards, testing & ancillary approvals

Verified

MDR electrical safety in place of the Low Voltage Directive: Electrical safety
MDR electromagnetic compatibility in place of the EMC Directive: EMC
Radio equipment requirements under act 917/2014: Wireless / radio

7 maintained overlays · 1 related fact

Checked 2026-09-07

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D14

Fees

Verified

Annual supervision fee by number of registered devices: EUR 500–6,000
Sterilisation-provider annual fee: EUR 1,000

13 maintained fee lines · 3 related facts

Checked 2026-08-25

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D15

Review clocks

Unresolved

Class I · Self-declaration (no notified body): 0 days

1 maintained pathway · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Registration has no fixed validity: National operator/device registrations have no expiry date: Fimea stores the notified data in its national device register (laiterekisteri) and keeps them for as long as supervision of the…

1 source-linked fact

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Material changes reported without delay: All notifiable operators must report to Fimea material changes to the data they have submitted, and operators under 49 § 1, 3 and 5 mom must immediately report if they no longer place a spe…

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

UDI recording for class III implants: As part of their monitoring system, social and health care units and other professional users that are legal persons or self employed professionals must record and keep the UDI (MDR Art. 27…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Application channel until EUDAMED: Until the EUDAMED clinical investigation module is taken into use, applications and notifications are submitted to Fimea electronically via Fimea's secure mail service (secmail.fimea.fi, ma…
Subject insurance required: The sponsor must ensure that insurance or other appropriate security is in force to compensate damage caused to study subjects, covering the liability of both the sponsor and the investigat…

5 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Fimea exemption permit (poikkeuslupa): Fimea may grant, on application, a time limited exemption permit to place a medical device on the market or into use even though the conformity assessment procedure under MDR/IVDR has not b…
Custom-made device prescriber: The written order (prescription) required to manufacture a custom made device may be issued only by a health care professional as defined in the Act on Health Care Professionals (559/1994)…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market surveillance reporting (Arts. 83-86): Manufacturers must implement a post market surveillance system (Art. 83) and a documented post market surveillance plan proportionate to the risk class and appropriate to the type of device…

1 source-linked fact

Checked 2026-08-29

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D22

Vigilance & incident reporting

Verified

Manufacturer incident reporting channel: Manufacturers report serious incidents, trend reports, periodic summary reports and field safety corrective actions to Fimea by email to laitevaarat@fimea.fi (also fax +358 29 522 3002 or p…
Legacy device reporting deadlines: For legacy directive devices (placed on the market under MDR Art. 120(3)/IVDR Art. 110(3)), manufacturers report to Fimea: a serious threat to public health within 2 days, death or unexpect…

4 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

FSCA notice language: Field safety notices under MDR Art. 89(8)/IVDR Art. 84(8) must be drawn up in the languages necessary for safety, and Fimea may order the manufacturer to prepare the notice in a specific la…
Website-blocking power: For non compliant devices presenting a serious risk to health, safety, the environment or property, Fimea may order a service provider to remove content referring to the product from a webs…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Marketing disclosure duties: In marketing, the manufacturer and the product or trade name given at registration must be stated; it must be indicated that the device is a CE marked medical device, and where a notified b…
Fimea marketing prohibition: If a device is marketed in violation of 10 § or MDR/IVDR Art. 7, Fimea may prohibit continuing or repeating the marketing and may order the recipient of the ban to correct incorrect or defi…

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Appeal route: A decision made by Fimea or a notified body under MDR, IVDR or the national act may be challenged by seeking rectification (oikaisu) as provided in the Administrative Procedure Act; appeal…

1 source-linked fact

Checked 2026-08-25

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Government fees

Full fee schedule (13 lines) →

Fimea registration fees in EUR · reviewed 2026-08-25

Fee line	Amount	Provenance
Annual supervision fee by number of registered devices	EUR 500–6,000	Verified
Sterilisation-provider annual fee	EUR 1,000	Verified
Importer annual fee	EUR 500	Verified
Distributor annual fee	EUR 500	Verified