Europe – Euro Convergence: Suboptimal use of MDR grace period is storing up trouble

Companies are failing to make optimal use of the Medical Device Regulation (MDR) grace period for compliance, adding to the problems created by capacity constraints and tight deadlines, according to experts who spoke at the Euro Convergence 2020 virtual meeting.

In November last year, the European Commission issued a corrigendum to the MDR, allowing manufacturers of certain class I products an additional four years, to 26 May 2024, to comply with the regulation. Under the extended the grace period, manufacturers can continue supplying class I products certified under the Medical Devices Directive (MDD)…