EU Medical Device Regulation (MDR) 2017/745
The application of the MDR, which was due to complete transition on 26th May 2020, has been deferred by 1 year to 26/05/21.
Following months of rumour and speculation, the official deferral announcement was published by the Official Journal of the European Union. 23 April 2020. Medical device companies had been under significant pressure to meet the 26th May deadline for ensuring that their products met the often more stringent MDR requirements. Although a key factor in the deferral decision was the significant delay in the EU designating ‘Notified Bodies’ to audit to the MDR, Brexit had added complication for those Notified Bodies based in the UK. The global impact of the Covid-19 pandemic, particularly on EU member states, had placed further stress on the medical device community and regulatory bodies, hence the sensible decision to delay its implementation.
KEY IMPACT: This means that manufacturers will have an additional year to meet the MDR requirements, with one year extensions to MDD certificate validity for devices already on the market –meaning that some MDD certificates will remain valid up until 2025. A subtle but important rewording to Article 120 paragraph 3 has been incorporated within the amendment that clarifies an extension up to 2024 for Class I devices that will become up-classified under the MDR.
The official EU text can be found at:
Extracts from EU text explaining the decision:
(5) In order to ensure the smooth functioning of the internal market, a high level of protection of public health and patient safety, to provide legal certainty and to avoid potential market disruption, it is necessary to defer the application of certain provisions of Regulation (EU) 2017/745. Taking into account the COVID-19 outbreak and the associated public health crisis, its epidemiological development, as well as the additional resources required by Member States, health institutions, economic operators and other relevant parties, it is appropriate to defer the application of those provisions of Regulation (EU) 2017/745 by one year.
(6) The application should be deferred for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from 26 May 2020. To ensure the continuous availability of medical devices on the Union market, including medical devices that are vitally important in the context of the COVID-19 outbreak and the associated public health crisis, it is also necessary to adapt certain transitional provisions of Regulation (EU) 2017/745 that would otherwise no longer apply.
By Avril McCarthy, D4D MedTech Theme Lead,