Notified bodies
Notified bodies are independent and impartial conformity assessment bodies designated by the EU Member States. Conformity assessment in accordance Medical Device Regulations (EU) 2017/745 and (EU) 2017/746 requires the participation of a notified body in the assessment before placing high-risk devices on the market. The manufacturer is responsible for requesting conformity assessment from a notified body if the risk class of the device so requires. Within the EU, the manufacturer of a medical device may freely choose the notified body it wishes to use, with due consideration given to the groups of devices the notified body concerned is authorised to assess. The notified body assesses the device and audits the manufacturer’s operations. A certificate of the due fulfilment of the requirements is issued to the manufacturer.
The participation of a notified body in the conformity assessment is required for:
- products of a higher risk class in compliance with MD Regulation (EU) 2017/745 (products of class IIa, IIb and III);
- class I products in compliance with the MD Regulation when the devices are placed on the market in sterile condition, have a measuring function or are reusable surgical instruments;
- devices of classes B, C and D in compliance with IVD Regulation (EU) 2017/746;
- class A devices in compliance with the IVD Regulation if they are placed on the market in sterile condition.
The requirements concerning the organisation, quality management, resources and processes of notified bodies are set out in the MD and IVD Regulations. Notified bodies shall have permanent availability of sufficient administrative, technical and scientific personnel with relevant clinical expertise on the device being assessed. A notified body shall also have a clinician in its employ.
Each EU Member State has an authority responsible for the designation and supervision of notified bodies. In Finland, the responsibility for the designation and supervision of notified bodies in accordance with the MD and IVD Regulations rests with Fimea. A list of notified bodies and their areas of competence can be found in the NANDO register maintained by the EU Commission. There are currently three notified bodies pursuant to the Regulations established in Finland, Eurofins Electric & Electronics, SGS Fimko Ltd and Sertio Oy.