CE marking

In the EU market, companies are not allowed to sell medical devices without a CE mark certificate if the medical devices are classified as class Is, Im, II1, IIb, or III. For medical devices that are classified as a class, you do not need to have a CE mark certificate; a Declaration of conformity from the manufacturer is enough in that case. 

In the case of class I medical devices, manufacturers need to register it in National regulatory authority and they need to issue a Registration notice.

All medical devices that want to be on the EU market must be in compliance with the Medical device directive (MDD 93/42/EEC) or Medical device regulation (MDR 2017/745), no matter the classification. In Article 1 of the MDR is stated: This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union. This Regulation also applies to clinical investigations concerning such medical devices and accessories conducted in the Union.

For more information, please see:

• EU MDR Article 1 – Subject matter and scope - https://advisera.com/13485academy/mdr/subject-matter-and-scope/