The MDR certificate is a new certification and not an amendment of the Medical Device Directive (MDD) 93/42/EEC. However, pending the obtaining of a certificate of conformity pursuant to MDR, a medical device can continue to be marketed if it holds a valid CE certificate issued under MDD.
A CE MDD certificate will remain valid until its natural expiry date even after May 26, 2021 (the date of full implementation of the MDR (EU) 2017/745), provided that, starting 2020, the manufacturer already demonstrates compliance during the audit phase to the MDR post-market surveillance, market surveillance, vigilance and registration of the Manufacturer and economic operators requirements.
Questions? Request more info from our experts