In the Netherlands, manufacturers of medical devices of risk class I must register their products via Farmatec’s online registration system (Notis) before placing them on the Dutch or European market. Farmatec is part of CIBG, an executive organisation of the Ministry of Health, Welfare and Sport (VWS).
Determine precisely the procedure by which you must assess the conformity of your product. This differs per risk class. Medical devices are divided into 4 risk classes:
- Class I (low risk)
- Class IIa and IIb (medium risk)
- Class III (high risk)
The classification rules for these can be found in Annex IX of the directive. The assessment procedures are described in general terms in Article 11 and in more detail in Annexes II to VII. For each class of risk you can choose from 2 or more possibilities for assessing your product against the essential requirements.
You must always involve a notified body in the assessment of devices in classes IIa, IIb and III. For Class I devices, involvement of a notified body is only required if your products have a measuring function or are marketed in a sterile condition.
After inspection, the notified body issues an inspection report or inspection certificate to the manufacturer.