ESIP views in light of the EC proposal amending the Medical Devices Regulation

In May 2017, Regulation (EU) 2017/745 on medical devices (Medical Devices Regulation - MDR) entered into force with the goal to increase the safety of medical devices, raise the requirements for the clinical evaluation of high-risk devices, harmonise assessment by Notified Bodies throughout Europe and increase transparency via a central database on medical devices available on the EU market (EUDAMED). ESIP supports the MDR as an important step towards improving patient safety and the quality of treatment using medical devices.

In light of the recent European Commission’s proposal amending the MDR and extending the transition period, we acknowledge hurdles concerning the limited capacity of Notified Bodies (NB) and difficulties in accessing those, in conjunction with stricter requirements and timelines. We understand concerns about possible supply disruptions from market withdrawals, leading to shortages and reduced competition.

In this context we present our recommendations to ensure availability of medical devices, while preserving the highest safety and quality standards, for the benefit of patients:

  • Avoid blanket extensions of the transition period and prefer targeted derogations under well-defined conditions e.g. that an application for an MDR conformity assessment is submitted before 26 May 2024, and provided that the respective medical device does not present unacceptable health risks
  • Adopt transparent and harmonised EU measures to address and prevent withdrawals of medical devices, especially for very rare conditions, avoiding market fragmentation through separate marketing authorisations at national level
  • Increase overall transparency, about devices at serious risk of withdrawals, reasons for withdrawals, as well as products authorised on the national level
  • Further support non-legislative solutions to strengthen the capacity of NB, building on the recommendations of the Medical Devices Coordination Group

Find more in the ESIP statement on the implementation of Regulation (EU) 2017/745 on medical devices.