Classification of medical device according to MDR 2017/745
The Regulation 2017/745 introduces new classification rules and changes some rules of the MDD 93/42/CE. Merc will help you classify your medical devices according to the MDR 2017/745and make an analysis of the impact of Regulation on product certification process.
We can review the existing data for your medical device and assist you for the following activities:
- Definition and implementation of regulatory requirements based on the device’s classification,
- Definition of the regulatory strategy in case of reclassification of device,
- Revision and gap analysis of the product technical file.