News - May 24, 2019

MDR: EUCOPE’s concern shared in latest Politico report

With almost one year to go before the implementation of the Medical Devices Regulation (MDR) 2017/745, the Brussels-based edition of Politico reports on the main problems for related stakeholders, whilst the European Commission is scrambling to get things in order before May 2020.

Representing EUCOPE in his capacity of co-chair of our Regulatory and Medical Devices Working Group, Jörg Plessl highlighted the specific needs of small and mid-sized companies, in his quote:

  “Even if there were 20 notified bodies available at the end of the year, this would still be less than half the number of what was available [previously] — with more work to do and less than six months left until the MDR becomes applicable. I’m afraid that this looks to me like being too little too late.”

Stressing the alarmingly low number of Notified Bodies designated so far, Jörg pointed out in his final quote for the article that “there will be a “high competition for limited capacity, possibly leading to an unlevel playing field for smaller companies or companies with specific products”.

The full report can be accessed here (paywall).

For further information on the above, please contact Laurent Louette, EUCOPE’s Communications and Public Affairs Manager.