Medical Devices Regulation: Amendment Defers Date of Application and Enables EU-wide Derogations
Posted on 06.05.2020
On 24 April 2020, Regulation 2020/561 was published, which amends the EU MDR. The amending Regulation took immediate legal effect, and made the following changes:
(1) The MDR’s date of application is postponed by 1 year, from 26 May 2020 to 26 May 2021. Until 26 May 2021, the former Medical Devices Directives remain in full legal application, and
(2) Article 59 of the MDR is brought into immediate legal effect. This means that, in exceptional circumstances like the present COVID-19 pandemic, ‘EU-wide derogations’ can temporarily be given to enable access of healthcare systems to critically-needed devices that have not yet undergone CE marking.
MedTech Europe welcomes this amendment to the MDR, which will allow the medical devices industry to maintain maximum focus on helping healthcare systems to combat COVID-19, and on addressing the pandemic’s impact on the whole healthcare ecosystem.
Nevertheless, MedTech Europe is continuing to call for the same measure to be implemented for the in vitro Diagnostic Medical Devices Regulation (IVDR). Since the COVID-19 outbreak, the EU’s IVDR implementation progress – which was already very limited – has come to a total halt. Moreover, it is regretful that the immediate possibility for EU-wide derogations granted to medical devices has not yet been granted to IVD, such as the new COVID-19 tests so badly needed right now across Europe.