Specific rules for the submission, assessment and conduct of clinical investigations with medical devices are described in the EU Medical Device Regulation (EU no 2017/745, also known as the Medical Device Regulation, MDR).

Amsterdam UMC developed a guidance map and factsheet specifically for the performance of Clinical scientific research involving medical devices.

On the factsheet you will find an overview with information about;

  • the main requirements of the MDR and the conduct of research,
  • where you can find the Amsterdam UMC policy,
  • who you can approach for advice
  • where you can find any further templates and instructions.

More information can be found on the intranetsite of medical technology.