ARTICLE SUMMARY:
A revision is in development to the oncoming Medical Device Regulation that would allow devices needing a notified body for the first time under MDR to benefit from the regulation’s grace period.
European Union member states are working with the EU Commission on a revision (formally, a “corrigendum”) to the oncoming Medical Device Regulation that would allow devices needing a notified body for the first time under MDR to benefit from the regulation’s grace period, government and industry officials confirm.
