News New medtech regulations

Updated MDR/IVDR Implementation Rolling Plan

Posted on 30.01.2019

Last month, the European Commission published an updated version of its MDR/IVDR Implementation Rolling Plan – click here. This document provides timing and next steps for the development of implementing regulations and other actions/initiatives.

Please find below a list of changes compared to the original version, which was published in October:

  • MDR Annex XVI products without an intended medical purpose: ‘Beginning 2019’ is the new date for the Commission’s informal consultation on the draft text of the common specifications.  The original version of the rolling plan gave ‘Q3 2018’ as the estimated timeline.
  • ‘Scientific bodies’ (i.e., expert panels, EU reference laboratories and expert laboratories): For the various implementing acts covering these bodies, the original version of the rolling plan referred to an ‘ongoing’ survey of MDCG members and stakeholders.  This survey is now marked as ‘finalised.’
  • Communications campaign:  The original version of the rolling plan indicated that more factsheets were scheduled to be produced by Q4 2018.  The new version captures that these additional factsheets were published in November 2018.
  • Medical Device Coordination Group (MDCG) subgroups: The new version of the rolling plan indicates that the call for stakeholder applications expired on 15 November, and that the new MDCG subgroups are expected to be established in Q1 2019.