With 26th May fast approaching, the Medical Device Co-ordination Group (MDCG) has published three new guidances, two updated guidances and an implementation/preparedness plan for the incoming Medical Device Regulation (MDR).
Member states and the European Commission (EC) have been working together to ensure that the new MDR legislation is operational from 26th May 2020. Their implementation/preparedness plan outlines their key objectives and priority areas for action including establishment of the EUDAMED database, increasing the number of notified bodies, medical device shortages, legacy devices and other implementing acts.
In addition to the implementation/preparedness plan, the MDCG have released a guidance to provide clarification on the changes to a legacy device that should be considered significant in terms of design or intended purpose, under MDR article 120(3).
Furthermore, they have recently released guidance offering more details for firms and notified bodies on clinical evaluations (MDR) and performance evaluations (IVDR) for medical device software. A new guidance has also been published on class I transitional provisions under Article 120 (3 and 4) – (MDR), outlining information on the Declaration of Conformity which should be provided by manufacturers of class I devices, for which MDR certificates are required by 26th May 2024.
Finally, the MDCG has published its third update to a guidance on BASIC UDI-DI and changes to UDI-DI, and a second update to the guidance on implant cards required under MDR.