Classification of medical device according to MDR 2017/745

Navigation

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.
Request information
Request information:
* Request subject:
* Name:
* Surname:
* E-mail:
Phone number:
* Request:
Privacy* :
I agree with the privacy policy
Digita i caratteri visualizzati nell'immagine sottostante
Ricarica
Classification of medical device according to MDR 2017/745