To respond to an Oral Question tabled by the ENVI Committee, the European Commission will provide answers on the implementation of the MDR during a debate in the plenary of the EP this Thursday 25 October. The debate will hopefully address many of the important elements for the implementation that COCIR has outlined in our publication “Implementing Medical Device Regulation - COCIR views on the way forward” at the beginning of this year. These include the timely designation of Notified Bodies, the establishment of the new database Eudamed, and the development of various implementing acts and guidance documents.
We would like to take this opportunity to highlight one of these essential elements: Harmonised Standards.
Medical device manufacturers have used Harmonised Standards to demonstrate compliance with the essential requirements of EU legislation for many decades. Harmonisation of standards is an essential element of the New Legislative Framework and its process is outlined in Regulation 1025/2012 on Standards. They ensure a level-playing field between manufacturers in the Market and serve as an important tool to facilitate placing on the market of safe and innovative medical devices.
Unfortunately, since 2010, there has been a huge decline in the percentage of Harmonised Standards for the Medical Device Directives referenced in the EU Official Journal - from 83% in 2010 to 12% in 2017. In fact, the MDR necessitates the harmonisation of some 300 standards. As of today, even the draft standardisation request has not been published and the European Commission only expects its publication in spring 2019. In addition, the proposed draft list includes a limited number of standards, not covering all devices in the scope of the MDR.
It is beyond doubt that the current process will not be able to deliver on time. Thus, medical device manufacturers will lose the presumption of conformity through compliance to these Harmonised Standards. Lack of Harmonised Standards for medical devices is very likely to jeopardize the ambitions of the MDR to provide the safest medical devices. It is also likely to result in longer time-to-market. The outcome will be decreased timely access to medical devices for patients, increased costs for EU healthcare systems, and an overall negative impact on the competitiveness of the EU Medical Devices industry.
We thus suggest that MEP’s ask the following question:
What concrete measures is the Commission putting in place to ensure timely availability of all necessary Harmonised Standards to be ready for the application of the Medical Device Regulation in May 2020?
COCIR Technical & Regulatory Affairs Manager