As the COVID-19 (Coronavirus) pandemic continues to grip Europe and the MedTech industry faces increasing challenges in trying to meet the unprecedented demand for necessary resources and technologies to fight the pandemic, the European Commission announced yesterday that it is working on a proposal to postpone the date of application of the Medical Device Regulation (MDR).
Delayed to 2021?
The MDR which will make significant wide sweeping changes to the existing regulatory system for medical devices was due to be implemented in 2 months on 26 May 2020 and the European Commission proposes to delay that date by a year.
The European Commission intends to submit such postponement proposals by the start of April and called upon the European Parliament and Council to accelerate the adoption of this postponement.
Commissioner for Health and Food Safety, Stella Kyriakides, reinforced that the rationale for the postponement is to ensure that “Vital devices needed to treat #COVID19 patients” remain available on the EU market during this pandemic.
It is expected that this proposal by the EU Commission will be welcomed not only by the MedTech industry (who had previously called for a 6-month postponement to commence after this crisis had passed) but also by national health and regulatory authorities whose attention is focused on grappling with the current crisis. However, the postponement may still face some opposition from some Member States, and we will continue to keep you updated as this develops.
In Vitro Diagnostic Regulation to be delayed?
MedTech Europe has also called upon the European Commission to delay the date of implementation of the In Vitro Diagnostic Regulation (IVDR) as despite its implementation date not being until 26 May 2022, they argue that preparations which would have already been underway to ensure compliance by this date are being disrupted as their “capacity is focused on the critical task of keeping diagnostic tests available despite the challenges the pandemic is creating for their production and distribution”.
The European Commission is yet to comment on this request for a delay in the implementation date of the IVDR.
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