Medical Device Regulation in Finland
Finland regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745). The Finnish Medicines Agency (Fimea) is the national competent authority. Finland has a strong tradition in health technology innovation and fully implements the EU harmonized regulatory framework for medical devices.
Recent Regulatory Updates
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EU IVDR governs in vitro diagnostic medical devices
Fimea details MDR clinical investigation requirements.
Sources Tracked by Qalico
Qalico continuously monitors 12 references across guidelines, regulations, and standards for Finland.
Regulations
Device Classification
Finland follows the EU MDR classification system. Class I devices are low risk (e.g., reusable surgical instruments, wheelchairs). Class IIa devices are low-moderate risk (e.g., hearing aids, surgical suction devices). Class IIb devices are moderate-high risk (e.g., infant incubators, external defibrillators). Class III devices are high risk (e.g., breast implants, cardiac resynchronization therapy devices). Classification is per EU MDR Annex VIII.
Official classification guidance →Official Guidance Documents
Official guidance from the Finnish Medicines Agency on medical device regulatory requirements, market surveillance, and vigilance.
Information on requirements for conducting clinical investigations with medical devices in Finland.
The European database for medical device registration and UDI management.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be placed on the Finnish market.
- EUDAMED registration and UDI compliance are required.
- Notified body assessment is mandatory for Class IIa, IIb, and III devices.
- Non-EU manufacturers must appoint an authorized representative within the EU.
- Post-market surveillance and vigilance obligations must be fulfilled with Fimea.
Pre-Market Requirements
Compliance with EU MDR 2017/745 and CE marking are required. Notified body involvement is mandatory for Class IIa, IIb, and III devices.
Full technical documentation per EU MDR Annexes II and III must be prepared, covering design, manufacturing, risk analysis, and clinical evidence.
A clinical evaluation is mandatory for all device classes. Clinical investigations require Fimea authorization and ethics committee approval.
Manufacturers must register in EUDAMED, including actor registration, UDI-DI assignment, and device registration.
Post-Market Requirements
PMS systems must be established per EU MDR. PSURs are required for Class IIa, IIb, and III devices.
Serious incidents and field safety corrective actions must be reported to Fimea in accordance with EU MDR Article 87.
PMCF activities are required to continuously confirm device safety and performance throughout the product lifecycle.
International Recognition & Reliance
As an EU member state, CE-marked devices are recognized across all EU/EEA member states.
CE-marked devices from EU member states are recognized in Switzerland under the MRA framework.