PP

P. Piscoi

2 records found

Background: The European Union Medical Device Regulation (MDR) requires manufacturers to undertake post-market clinical follow-up (PMCF) to assess the safety and performance of their devices following approval and Conformité Européenne (CE) marking. The quality and reliability of ...

Improved clinical investigation and evaluation of high-risk medical devices

The rationale and objectives of CORE-MD (Coordinating Research and Evidence for Medical Devices)

In the European Union (EU) the delivery of health services is a national responsibility but there are concerted actions between member states to protect public health. Approval of pharmaceutical products is the responsibility of the European Medicines Agency, whereas authorizing ...