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 roadmap 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.