Postponement of the medical device regulation (MDR) – chances and challenges
by Franz-Josef Binmöller
On 3 April 2020, the European Commission (EC) submitted a proposal to postpone the implementation of the Regulation (EU) 2017/745 (MDR) by one year to 26 May 2021 following the outbreak of COVID-19 . The current pandemic presents an unprecedented challenge to Member States and is a high burden for national authorities, health institutions and economic operators. Among these, Medtech companies are under additional strain, as they simultaneously have to consider the upcoming MDR implementation, deal with the effects of the outbreak on their organizations and meet an unprecedented demand for personal protective equipment, diagnostics, ventilators and other devices. Therefore, the European Parliament adopted the European Commission proposal on 17 April 2020 by emergency procedure, allowing the Medical Devices Regulation to be postponed by one year until 26 May 2021 . The delay was made official by the publication in the Official Journal of the European Union on 24 April 2020.
The delay of the MDR application will take the pressure off notified bodies, national agencies, device manufacturers and other parties and allow to focus on urgent solutions of the health crisis associated with the COVID-19 pandemic. Manufacturers now have extra time to prepare for the stricter requirements of the MDR – which is four times longer and contains five more annexes than the previously applying medical device directive (MDD).
Under the MDR, the regulatory requirements to place a new medical device on the EU market are significantly higher, especially apparent in an increase of the level of detail for the technical documentation, labelling and clinical data. Manufacturers will also have to comply with the increased requirements for post-market activities, particularly related to Post-Market Surveillance (PMS), i.e. the continuous collection and review of clinical data. Finally, some manufacturers may also be on the brink to a reclassification of their devices to a higher risk class, and therefore require careful planning, review and re-implementation of their products and necessary data to comply with the new requirements.
The extension of the transition timelines allows device manufacturers to still place new devices on the market under the current Directives 90/385/EEC and 93/42/EEC (Medical Device Directives, MDDs), as new certificates can still be issued and existing certificates can be renewed. Devices placed on the market prior to 26 May 2021 can be made available on the market and put into service until 26 May 2025 under the MDD. The delay also gives manufacturers an additional year to comply with the MDR requirements related to Post-Market Surveillance, Market Surveillance, Vigilance, and registration of Economic Operators. For example, manufacturers now have the chance to prepare and collect necessary clinical data, while the full impact of the MDR is postponed and their devices are still authorized. The European Commission’s proposal has opened many opportunities and last-minute chances for medical device professionals – make sure you make the most of them!
You want to make sure you navigate the rapidly changing medical device landscape in the best possible way and benefit the most for your product strategy? Biopharma Excellence has extensive experienced in the development of drugs and devices in both the EU and the US. We understand the unique challenges of medical device development programs and know how to manage and solve them in a constantly evolving environment. Please don’t hesitate to contact us and benefit from our knowledge.