mdc medical device certification GmbH services

In the area of CE marking we cover a wide range of devices under Regulation (EU) 2017/745 on medical devices and 98/79/EC on in vitro diagnostic devices.

For legal manufacturers of in vitro diagnostic devices we offer conformity assessment procedures according to Directive 98/79/EC as a Notified Body (EU Identification Number „0483“).Conformity assessment with the involvement of a Notified Body is mandatory for all manufacturers of products according to Annex II list A and B, as well as, for self testing products by lay users.