News New medtech regulations Newsletter

New version of the European Commission’ IVDR/MDR rolling plan

Posted on 28.02.2019

Implementation Rolling Plan was published on 19 February and provides updated timing and next steps for the development of implementing regulations and other actions/initiatives.

1) MDR Annex XVI products without an intended medical purpose: Q1 2019’ is the new date for the Commission’s informal consultation on the draft text of the common specifications. The December version indicated ‘by beginning 2019’. Also target date is moved from November 2019 to Q1 2020.

2) ‘Scientific bodies’ (i.e., expert panels, EU reference laboratories and expert laboratories): For the various implementing acts the surveys are now marked as ‘finalised’ (as in December 2018). Only change: the move into drafting stage for the act on expert panels.

3) Eudamed: drawing up of functional specifications – EUDAMED for PMS and clinicals may be only partly available or not at all by the date of application.

4) Communications campaign: The new dedicated website and first updated library are live. New factsheets have been published in January 2019. Release of existing factsheets in some major non-EU languages has also started. Social media campaign under preparation.

5) Medical Device Coordination Group (MDCG) subgroups: the evaluation of the applications is still ongoing, and that the new MDCG subgroups are expected in Q1 2019.

6) EU Medical devices nomenclature – the Commission is currently finalising its assessment in the view of a final decision to be taken by Q1 2019.

7) Notified Body designation: 42 applications received by the EC, 3 further joint assessments scheduled (apart from the 25 already carried out).