In the four pages position paper, MedTech Europe underlines that the industry has significant concerns about the implementation status of the MDR and IVDR which will be applicable on 26 May 2020 and 26 May 2022 respectively. The position paper stresses that:
“the industry’s ability to keep products on the market beyond the 26 May 2020 and 26 May 2022 deadlines, could be seriously jeopardized by the slow progress in putting into place the critical infrastructure that will enable the new regulatory systems to work.
In the event of insufficient time between the establishment of the system and the (re-) certification of products before the dates of application, products will not be allowed on the market anymore. Consequently, they will be no longer available for patients and healthcare systems.”
In the document, Medtech Europe questions the ability of notified bodies to be designated in time for transitioning medical devices companies to the MDR and IVDR but also the notified body’s current resources and expertise to deal with workload created by the new Regulations and the transitional periods.
Brexit could also impact the transition of the industry to the MDR and IVDR and the availability of medical devices on the EU market. Medtech Europe underlines that between 30 and 40% of medical technologies in the EU are CE marked with the involvement of UK notified Bodies. In case of a hard Brexit, these UK notified bodies may lose their rights to conduct conformity assessments and the CE Certificate of Conformity that they issued to manufacturers may lose their validity. Such situation would lead
The document also stresses that implementing acts, guidance, standards or common specifications still need to be adopted to ensure application of the new Regulations.
MedTech European proposes three options to address the issues raised by the timeline for the application of the new Regulations:
a) A ‘stop the clock’ mechanism, that freezes the remaining transition time for both Regulations until full readiness of the system has been achieved;
b) An extension of the critical dates of 26 May 2020 and 26 May 2022, for all products;
c) An extension of the critical dates of 26 May 2020 and 26 May 2022, for legacy products only.
Please do not hesitate to contact us should you have any question concerning the above development related to the MDR and IVDR.
Authored by Fabien Roy