EU regulators propose one-year delay on Medical Device Regulation to allow sector to focus on tackling COVID 19
By Marie Gavin and JP Gilmartin
26 March 2020
Regulation 2017 /745 on Medical Devices (“MDR”) came into force on 26 May 2017. The primary objective of the MDR is to establish a robust and transparent regulatory framework for medical devices which ensures a high level of patient safety whilst supporting innovation. The MDR aims to allow greater legal certainty in the rules relating to medical devices that are applied across EU member states by placing stricter requirements on clinical evaluation and post-market clinical follow-up and requiring better traceability of devices through the supply chain.
In order to afford manufacturers, notified bodies, regulatory authorities and all other affected parties a significant lead time to ensure that devices, documentation, procedures and systems comply with the new requirements, the MDR provides for a staggered transitional period over three years with full application of the MDR due to come into effect on 26 May 2020.
Even before the Covid-19 global crisis, the medical device industry had expressed concern about the ability to ensure compliance with MDR by 26 May 2020 given the limited number of Notified Bodies that have received accreditation and the delay in implementation of the European database on medical devices (Eudamed). Whilst various submissions have been made to the European Commission seeking delay of full MDR implementation for these reasons, the response of the European Commission to date has been that the timeline was realistic and achievable with no indication being given of any proposed delay.
Earlier this week, the trade association MedTech Europe requested a postponement of full implementation of MDR until six months after the present crisis has passed (as declared by the World Health Organisation) given that the industry was “working relentlessly to provide personal protective equipment (PPEs), diagnostics, respiratory devices and other critical medical equipment to patients, healthcare workers, and hospitals on the COVID19 frontline” and that this severely disrupted the ability of healthcare stakeholders to implement the MDR within the fixed transition timeline.
The Socialists and Democrats in the European Parliament (including Mairead McGuinness vice-president of the European Parliament) have also written an open letter to the European Commission this week seeking delay of the full implementation of MDR in order to allow the industry to divert resources to focus on the "essential and urgent work" of tackling Covid-19 specifically citing the need for the industry to focus on meeting demands for medical devices such as ventilators.
Facing increasing mounting pressure to delay, a spokesperson for the European Commission confirmed yesterday that the European Commission is putting together a proposal to postpone full implementation of the MDR by one year in light of the Covid-19 pandemic and indicating that necessary work was being undertaken to submit this proposal in early April. Given the impending MDR deadline policymakers are calling on the European Parliament and the Council to adopt the proposal quickly in order that the industry can re-deploy resources as soon as possible. The European Commission hope that this will relieve pressure on national authorities and industry and will allow them to focus fully on urgent priorities related to the Covid-19 crisis.
In an unprecedented week that has seen Italian doctors make decisions about who lives and who dies based on the availability of ventilators, news of the proposed MDR implementation delay will be welcomed from an industry that is grappling to meet rocketing demand and will allow the focus to remain on expanding production lines and implementing timing efficiencies in supply chains over the coming weeks.
For more information on the content of this insight please contact:
JP Gilmartin, Partner | E.firstname.lastname@example.org | T. +353 91 895343
Marie Gavin, Solicitor | E.email@example.com | T. +353 91 895332