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