EU - Medical Device Regulation 2017/745 (MDR).

For a conformity assessment procedure according to MDR, the costs are calculated individually on an hourly basis, taking into account the company size, number of locations and complexity of the products.

The hourly rates for the services of DQS Medizinprodukte GmbH in Germany are as follows, plus statutory VAT:

MDR einreichen

CE Marking

Do you want to know more about the approval of medical devices for sale or distribution in the European Economic Area?

Szymon Kurdyn
Head of Notified Body

Product Manager ISO 13485