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:
Do you want to know more about the approval of medical devices for sale or distribution in the European Economic Area?
Szymon Kurdyn is Head of the Notified Body (non-active medical devices) and Product Manager for ISO 13485 (DAkkS accreditation). In this position, he keeps an eye on the regulatory and normative framework of certification activities, is in close contact with authorities, our experts and our customers and informs about changes and other relevant topics.
