Clinical evidence under the EU Medical Device Regulation: More firework on the way.

fireworkThe EU Medical Device Regulation (MDR) and the In Vitro Diagnostic device Regulation (IVDR) entered into force, local governments published guidance how to deal with the new medical device regulations, there is debate on the implementation of the MEDDEV 2.7/1 Rev. 4, and yet the number of posts from my end in 2017 have been minimal. I am afraid this is only symptomatic of what is happening in the clinical environment of medical devices in Europe: the demand for qualitative and manufacturer owned clinical evidence is rising, and medical device companies have only 2 years left to perform a gap analyses AND to address any gaps in their clinical data.

A snap shot of some key events from clinical perspective in 2017:

April 5, 2017 the EU adopts the new MDR and IVDR taking effect 2020 and 2022 for the MDR and IVDR respectively,

May 5, 2017 the final versions of the MDR and IVDR are published,

May 2017: UL publishes a white paper on medical device clinical investigations and ISO 14155,

May 25, 2017, the MDR comes into force

June 2017, EMA announces delay of the application of the clinical trial regulation until 2019 due to challenges with the EU portal.

August 2017, TUV SUD announces extension of the implementation timeline of MEDDEV 2.7/1 Rev 4.

Throughout 2017: several posts on the impact of the GDPR taking effect in May 2018, one includes a comparative table EU vs US you can find here,

December 12, 2017: Dutch Health Ministry and Health Inspection publish guidance on key changes for medical devices,

December 18, 2017, MHRA updates guidance on EU regulations for medical devices and in vitro diagnostic devices.

In short, one can only conclude that 2017 has been an exciting year for medical devices reflecting an environment of change with more firework to come, especially when looking at it from clinical evidence perspective: Changes that concentrate around a more thorough (premarket) clinical evaluation (refering to my previous blog post on that topic) with a more solid clinical evidence base, and a better, stricter postmarket surveillance program that includes Postmarket Clinical Follow-up studies. Medical devices companies better prepare themselves, and if not started at this point in time, perform a clinical evidence gap analysis and start collecting their own clinical data where needed NOW!

Please feel free reaching out in case of any questions regarding this post, or when you are looking for support with your medical device clinical evidence strategy.



About Annet Muetstege

My name is Annet Muetstege and I am a clinical research expert, based in The Netherlands, with over 25 years of experience in all aspects of clinical evidence planning and execution especially in medical devices. I am the co-founder of Applied Clinical Services.
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