ESIP argues for no delay in application of the MDR

At the end of May 2017, after long and intensive political debate, the new European Medical Device Regulation (Regulation EU 2017/745; MDR) entered into force. Its main goals are to increase the safety of medical devices placed on the market, to raise the requirements for the clinical evaluation of high-risk devices, to establish transparency by implementing a central database that is at least in part publicly accessible, and to harmonise the quality of Notified Bodies throughout Europe.

Furthermore, the new Regulation will allocate several medical devices to a higher risk-class. This reform is necessary to adapt the classification rules of the old medical devices Directive from 1993 to today’s state-of-the-art of technologies such as medical apps that might influence treatment decisions for conditions such as heart failure or depression. In ESIP’s view, the new MDR is an important and overdue step towards improving patient safety and the quality of treatments using medical devices. 

  • First and foremost, ESIP strictly opposes any postponement to the date of application of the new Regulation.
  • Since the Regulation came into force, Member States and the European Commission have been working intensely on its implementation and creating the necessary structural framework conditions.
  • It could be foreseen that compliance with the new quality standards in terms of personnel and infrastructure would be challenging for many existing Notified Bodies, resulting in a smaller number of such bodies at least in the short term.
  • As of May 2019, 47 of the existing 59 Notified Bodies have applied for renewed notification, 26 bodies have already been scrutinised by the so-called “Joint Assessment” and seven more assessments were scheduled by the end of May[1]. The European Commission expects that about 20 bodies will be notified by the end of 2019 and will resume their work.
  • In our view, there was – and still is – enough time for manufacturers, authorities and Notified Bodies to prepare for the application of the new medical device Regulation in a timely manner. The current application date of 26 May 2020 must be upheld to ensure improved patient safety.


[1] Dr. Martin Renhardt, Sozialministerium Österreich; EUNetHTA-Workshop, Wien, 28.05.2019., Seite 14. Zugriff am 08.08.2019.