European Union Medical Device Coordination Group Publishes List of Action Items
Back in June 2022, EU Health Ministers expressed concern that innovative medical devices would be delayed in reaching the market and that, generally, the supply of medical devices would be disrupted. In response, the Medical Device Coordination Group (MDCG), an advisory and coordinating body of Member State representatives responsible for administering Regulation (EU) 2017/45 governing medical devices (MDR) and Regulation (EU) 2017/46 governing in vitro diagnostic medical devices (IVDR), produced at the end of August 2022 a list of action items to make the most of the transition periods which both the MDR and the IVDR provide for (see, attached MDCG Position Paper 2022-14). The MDCG stresses that its measures are designed to improve the efficiency of the new regulatory framework, rather than alleviate its requirements, and that they will certainly not be implemented at the expense of the devices’ safety.
The action items fall in four broad categories that concern (i) the increase of the capacities of the Notified Bodies (NBs); (ii) broadened access to NBs; (iii) the enhanced state of preparedness of medical device manufacturers; and (iv) miscellaneous measures.
Notified Bodies’ Capacities
Unsurprisingly, a majority of action items focus on NBs, the conformity assessment bodies responsible for evaluating and certifying most medical devices. This is because the MDR and IVDR greatly expanded the obligations on NBs and made them responsible for many more products. At the same time, the lists of newly accredited NBs under both Regulations have been slow to grow. The MDCG now urges NBs to conduct hybrid audits to speed up the conformity assessment. It also advocates for the use of evidence from previous assessments in new procedures and for a flexible approach towards the auditing of legacy devices. The list is much longer in trying to reduce administrative burdens and eliminate redundancies. It also addresses the assessment and designation process of new NBs.
Other Action Items
The MDCG makes special efforts to help small and medium-sized device manufacturers and first-time applicants. It also deals with a broad range of additional issues such as clinical evaluation; orphan devices (a concept still in need of a definition); medical devices incorporating an ancillary medical substance; and companion diagnostics.
The MDCG will continue to monitor the availability of medical devices. For its part, the European Commission will prepare a report for the Council of Ministers in December 2022.