In writing and set in stone with the publication on the Official Journal of the European Union.
On Friday, April 17, 2020, the European Parliament approved to delay by one year the EU Medical Device Regulation with 693 votes in favor, 1 against and 2 abstentions. A great support!
HOWEVER, the proposal now has to be approved by the member states and published in the Official Journal before taking effect. This should only be a formality.
The delay is due to the COVID-19 fight but it will be beneficial for others as well. Here is the European Parliament press release.
The 12 month delay is just a short period considering that the Importer will now request MDR compliant products. This special issue will be covered by our Webinar.
The European Commission adopted a proposal to postpone the implementation of the EU Medical Device Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions.
Here is the full proposal.
Medtech Europe asked the Commission to delay the MDR. Here is the Press release.
German association supports the initiative and it seems that the German Ministry of Health is responding to this positively.
Peter Liese MEP who was one of the lead Parliament member for the implementation for the MDR and IVDR is communicating that he believes it is necessary that the MDR must be postponed. Here is his twitter post.
MDSS certainly supports such initiative for the sake of the patients affected by the current situation and our clients during this difficult times. A delay will release resources to cope with the current situation as well important products which may have been banned due to the MDR requirements can still be placed on the market.
Here is the College meeting of 25/03/2020 video