MDR/IVDR Second Corrigenda published

The second corrigenda for the European Medical Devices Regulation (MDR, 2017/745) and In Vitro Device Regulation (IVDR, 2017/746) were published in the Official Journal of the European Union on 27 December 2019, although the ‘New Regulations‘ page of the Commission website has not yet been revised to indicate their availability.

The MDR corrigendum is available from this link, and the IVDR corrigendum from here.

MedTech Europe, the pan-European industry Association for the medical device industry, has published a ‘High-level Analysis‘ of the corrigenda, in which it is explained that the main change is the introduction of a four-year grace period for Class I devices under the MDR that will, as a change from compliance with the preceding Medical Devices Directive (MDD, 93/42/EEC), require the involvement of a Notified Body in the conformity assessment process.