Supervision of notified bodies

Supervision of notified bodies in Finland

Fimea is responsible for the continuous monitoring of notified bodies to ensure that they comply with the requirements set out in the MD and IVD Regulations on a continuous basis and fulfil their obligations under these regulations. Notified bodies shall, at the request of the authority responsible for them, provide all the relevant information and documents based on which the authority, the Commission and other Member States can verify conformity.

Fimea carries out its monitoring and assessment actions in accordance with an annual assessment plan and is responsible for reporting these actions to the Medical Device Coordination Group and the Commission. The monitoring includes, among other things, annual and, if necessary, unannounced inspection visits, monitoring based on market surveillance, and the review and inspection of the assessment of technical documents and clinical assessment.

Notified bodies are re-assessed in collaboration by the EU Commission’s assessment group and the designating authority at least every 4 years.

The fees related to the designation and supervision of notified bodies can be found via the page Fees.