An updated EU regulatory framework for medical devices was adopted in 2017 in order to address the shortcomings of the previous regime which has been in place for over 25 years as well as to capture the developments in medical technologies that has taken place in that time. The new framework consists of two new EU regulations, the Medical Devices Regulation 2017/745 ("MDR") and In Vitro Diagnostic Regulation 2017/746 ("IVDR"), which were adopted in April 2017.
The Regulations have a staggered transitional period which originally anticipated full application of the MDR from May 2020 and full application of the IVDR from May 2022. However, as we discuss in our previous Insight, in the context of the unprecedented challenges posed by the outbreak of the Covid-19 pandemic, it was decided to extend the relevant periods for implementation of this new regime.
The updated timeline envisaged that by 26 May 2024 all devices placed on the market must be in compliance with the MDR. However, as this deadline draws nearer, medical and industry associations have expressed fears that the more stringent regulatory regime, which requires all devices to be re-certified, would lead to delays in approval of vital medical devices.
At a meeting of the EPSCO Council on 9 December 2022, the EU Health Commissioner Stella Kyriakides further cited the impact of Russia's war against Ukraine on the availability of raw materials and delays in the designation of notified bodies, which are responsible for the assessment and approval of medical devices, as strains on market readiness for full implementation of the MDR. In order to mitigate the risk of EU-wide shortages in supply of life-saving medical equipment, Commissioner Kyriakides proposed amending the MDR to further extend to the deadline for compliance with its provisions (the "Proposal").
The Proposal will introduce staggered deadlines based on classification of devices according to their risk, extending to 2027 in respect of high risk devices and 2028 in respect of medium and low risk devices. Importantly, it is proposed that qualification for the extension would be conditional on satisfying certain conditions as to safety. Further, in order to prevent the discarding of safe medical devices, it is proposed to abolish the deadline of 26 May 2025 for the "sell off" of products lawfully placed on the market under the previous regulatory regime.
The Proposal will be formally tabled before the European Parliament and the Council of the EU in January 2023. Its approval would go some way to alleviating the significant challenges to manufactures of medical devices in seeking to adapt to the new requirements under the MDR.
Matheson’s EU, Competition and Regulatory Group continue to closely monitor developments in this area and we are on hand to offer our guidance and advice. If you have any queries in relation to the above, please contact Kate McKenna, Simon Shinkwin or Neringa Juodkunaite.