EU medical device regulation - The Countdown

by Callum Moore

Since joining RMG, I have enjoyed delving into the medical market in an effort to broaden my knowledge base. One thing I have noticed is over the past few decades the regulation of the safety of medical devices has remained somewhat unchanged. With product innovation at an all-time high and several notable product failings over the past few years (Johnson & Johnson, Intuitive Surgical, Bayer) highlighting serious weaknesses in the current regulatory system, a strong case for modernising medical device ruling was made and it is pleasing to see that, following several years of negotiation, new legislation was agreed by all member countries in June 2016 and will become law in late 2019/early 2020

The requirements of the medical devices regulation coming into play in 2019/2020 :

The medical devices regulation requires increased inspection of medical device products before they enter the market and also tighter monitoring once they are in use on patients. Medical device products also require the formation of a unique device identification (UDI) system to ensure full compliance and traceability, this will make it a lot easier for businesses to recall products with issues and to help fight against deception in devices.

In terms of device product types, the approved legislation will seek to:

What effects can I see coming into the market?

I expect to see lots of changes in the market for the better, in my opinion strengthening guidelines and regulations can only mean a safer usage for patients but with these regulations now coming into place, I look forward to seeing how our clients at RMG continue to innovate whilst working under the such defined guidelines.

SourceImproving the safety of medical devices

Fiona Maini - Director, Healthcare and Life Sciences
Sarah Chan - Senior Manager, Risk Advisory, Life Sciences

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