The Medical Device Coordination Group (MDCG) which is the expert panel of the EU Member States and the EU Commission published on 20 October a Guidance Document for manufacturers, importers, and distributors of “legacy devices” on which MDR obligations they must comply with.
The Medical Device Regulation 2017/745 (MDR) provides that certain devices certified under the previous Directive (Medical Device Directives 93/42/EEC) may, for a transitional period continue to be placed and sold on the EU market after the date of application of the MDR on 26 May 2021 without those products being specifically certified under the MDR, providing that the MDR rules around surveillance and vigilance can be complied to.
The Guidance provides detailed information on the extent of periodic safety update reports which must be created and submitted, along with the fact that there is no need to appoint a Person Responsible for Regulatory Compliance (PRRC) for such legacy devices.
Contact RegASK to know more about medical devices regulation changes. Get in touch with RegASK’s experts.
Contact RegASK for more details Read more