The European Commission has adopted a proposal to postpone the application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May 2020. The decision means that the MDR will now apply one year later than originally planned, and will be effective from 26 May 2021. The new effective date falls after the end of the UK’s agreed transition period with the EU, which is due to end on 31 December 2020.
The MDR aims to improve the traceability features and safety management of medical devices sold within the EU. As a result, it places stricter requirements on manufacturers of certain medical devices to conform to the MDR’s standards by carrying out lengthier conformity assessments. Once the assessments have been carried out, manufacturers can place a CE mark on their product to show the requirements have been met.
The postponement of the MDR comes as a direct result of the Covid-19 pandemic and aims to ensure that member states can address medical device shortages resulting from the coronavirus, as there has been huge pressure on member state health services. In its press release on 3 April, the Commission made this clear, stating; “Our priority is to support member states to address the coronavirus crisis and protect public health as powerfully as possible – by all means necessary. Any potential market disruptions regarding the availability of safe and essential medical devices must and will be avoided.” It is hoped that the postponement of the MDR will avoid shortages that would have arisen if medical equipment were to be delayed for non-compliance or due to capacity limitations of the authorities assessing compliance.
This will have been welcome news to many, and indeed there were industry calls to postpone the application of the MDR from trade associations, and also from medical device industry group MedTech, which has also called for a delay in the application of the In Vitro Diagnostic Medical Devices Regulation (IVDR). MedTech welcomed the MDR delay, stating that it “will allow the medical industry to maintain maximum focus on helping healthcare systems to combat Covid-19.” The industry will now benefit from an additional year to bring their products in line with the requirements of the MDR.
The application date of the IVDR has not been affected by this decision, however, and it will still be applicable from 26 May 2022.
In addition to postponing the application of the MDR, the Commission’s proposal also partially amends some of its provisions. Article 59 grants competent authorities from member states the power to allow medical devices that have not met the requirements of the MDR to be placed on the market in that member state, if it is in the interest of public health or patient safety. In exceptional cases, the Commission also has the authority to extend the validity of a national derogation from conformity assessment requirements for a limited period to the rest of the EU. The postponement regulation makes Article 59 applicable immediately, including in relation to decisions taken under the current Medical Devices Directive.
The Commission’s decision to postpone the MDR means that it will now come into force after the UK-EU transition period. Currently, by virtue of the Withdrawal Act 2018, the Medical Device (Amendment etc) (EU Exit) Regulations 2019 bring the MDR into UK legislation. They are due to come into effect on 31 December 2020, at the end of the transition period, which is now prior to the effective date for the EU MDR. The UK Government has acknowledged this potential issue and is set to provide guidance in due course, which will take into account Government decisions on the future of UK regulation.
The postponement demonstrates the international effort to combat Covid-19 and a pooling of resources to expedite the process. The Commission recognises that resources of manufacturers, national authorities and other stakeholders are temporarily redirected, and as a result has given the industry much needed breathing space during the pandemic to tackle coronavirus-related priorities. The MDR makes important amendments to the medical devices industry, helping to harmonise processes across the EU and increase protection for citizens. Whilst industry has welcomed the break, it is simply a postponement due to current exceptional circumstances and those affected should not take their eye off the ball with what is a complex and beneficial piece of legislation.
We will continue to monitor developments. If you wish to discuss the requirements of the new regulations or the impact of Covid-19 on your business, please contact Rachel Bradley in our life sciences team.
This article has been co-written with trainee solicitor Ebi Oni.