Medical Devices Approval

CE marking is the medical device manufacturer’s claim that a product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the European Union.

The CE marking process can be a challenge for both smaller companies and global manufacturers. The CE mark is a legal designation that the manufacturer’s product has met the requirements of all relevant Medical Device Directives in the EU. In order to obtain CE certification, you must identify the appropriate conformity assessment route for your product.

We have specialization in certification medical devices according to 93/42/EEC – Medical Devices Directive (MDD)

PRODUCT SUPPORT s.r.o. Zelený Pruh 1560/99
140 00 Praha 4,
Czech Republic