Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) aim to ensure that safe and performant medical devices are being placed on the EU market while supporting innovation.
These regulations introduce important improvements such as stricter control for high-risk devices via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence and increased transparency. To this end, they require establishing scientific bodies, namely:
- expert panels
- expert laboratories
- EU Reference Laboratories (EURLs).
Further information on what are expert panels in the field of medical devices and IVDs.
