Will Europe’s incoming Medical Device Regulation improve evidence standards and transparency?
Evidence requirements and transparency of evidence for medical devices will probably improve under the incoming EU Medical Device Regulation, but will continue to fall short of the standards applied to medicines, a paper published by the British charity HealthWatch has found.
Issues covered in the paper:
Strengths and weaknesses of the Medical Device Regulation
Third party regulation through ‘Notified Bodies’
Evidence requirements for medical devices
The challenges of designing clinical trials for medical devices
Transparency and integrity of assessment processes
Transparency of evidence on device benefits and harms
The EUDAMED database and registration of device trials
Post Brexit medical device regulation in the UK
Recent regulatory initiatives from around the world
The paper formed the basis for a symposium on medical devices held in London in June 2019. All symposium materials are available on the HealthWatch website.
Note: HealthWatch commissioned TranspariMED founder Till Bruckner to write the paper cited above in a personal capacity. HealthWatch, which itself receives no industry funding, has in the past funded some of TranspariMED’s work, as disclosed on the TranspariMED website.