COVID-19: European Commission proposes delaying the May 2020 application of the EU Medical Devices Regulation (EU) 2017/745Tuesday, 31 March 2020
As the novel coronavirus known as COVID-19 continues to unsettle Europe (and the rest of the world), and disrupt medical device companies in their current manufacturing operations, the European Commission, on 25 March 2020, stated that it is putting together a proposal to request the European Parliament and Council to delay the implementation of Regulation (EU) 2017/745, or the new Medical Device Regulation (the MDR), by one year in light of the COVID-19 pandemic.
The MDR, together with Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), replace the three existing medical device Directives (93/42/EEC, 98/79/EC and 90/385/EEC), and came into force on 25 May 2017. The two new regulations will come into full application (i) on 26 May 2020 for medical devices, and (ii) in May 2022 for in vitro diagnostic medical devices, following a transition period to allow manufacturers, notified bodies and authorities to comply with the changes. Both regulations will directly apply in EU countries and do not need to be implemented into national law.
The MDR and the IVDR represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years. The new regulations aim to substantively change several areas to account for technological and scientific progress and to improve transparency and traceability of the regulatory system.
The COVID-19 pandemic creates new and enormous challenges for many medical device manufacturers in the context of the MDR, where the focus will now be on production of life saving medical equipment during this crisis, whilst unfortunately also experiencing disruption in their own supply chains, instead of preparing for the implementation of the MDR (and eventually the IVDR).
The move by the European Commission follows lobbying by representative bodies in the medical technology industry to postpone the implementation of the MDR on the basis that this could help safeguard healthcare systems as medical device companies work to tackle the COVID-19 pandemic. In a press release available here, MedTech Europe, the European trade association for the medical technology industry (including diagnostics, medical devices and digital health) called on the European Commission to pause the date of application for the MDR and resume it six months after the present crisis has passed (as declared by the World Health Association).
Additionally, in a letter, sent on 24 March 2020, to the European Commission President, Ursula von der Leyen, and Commissioner for Health and Food Safety, Stella Kyriakides, the Socialists and Democrats in the European Parliament said they are also open to proposals by the European Commission to make changes to the current Directives. A copy of that letter is available to view here.
EU spokesperson, Stefan de Keersmaecker, in a statement issued on 25 March 2020, confirmed that the European Commission is “working hard to submit this proposal in early April and call on Parliament and Council to adopt it quickly as the deadline to force is in May”. He continued by stating that the postponement of the MDR "will relieve pressure from national authorities and industry and allow them to focus fully on urgent priorities related to the coronavirus crisis." The full statement is available to watch here.
Questions about whether medical device companies would be ready for the implementation date of the MDR by 26 May 2020 have lingered since at least last year. As the COVID-19 pandemic continues to gain force and have far ranging consequences, it is likely to impact on current and future operations of medical device companies. A postponement of the MDR by the European Parliament and Council would certainly go some way to recognise the burden medical device companies are presently facing in helping healthcare systems all over the world to overcome this outbreak, whilst managing the effects of the pandemic on their business operations.
We will continue to monitor the landscape and we will provide further updates as the situation evolves.
Please note that the content of this summary does not amount to professional advice. Legal and tax advice should be sought in respect of specific queries. The COVID-19 situation is evolving rapidly and this update is provided on the basis of information available as at 31 March 2020.