Medical devices face tougher premarket testing under new EU lawsBMJ 2017; 357 doi: https://doi.org/10.1136/bmj.j1870 (Published 13 April 2017) Cite this as: BMJ 2017;357:j1870
- Deborah Cohen
- The BMJ
The European Parliament has passed new legislation to tighten regulation of medical devices that will require high risk devices, such as hip implants, to undergo more premarket testing and assessment.
European device regulation has come in for criticism after a series of high profile failures—including hip replacements, breast implants, and pelvic meshes—that have resulted in harm to patients.
MEPs voted in a raft of changes detailed in a 600 page dossier that has taken over five years to agree. At the heart of the updated legislation is the need for more clinical evaluation before and after a device is put on the market. Manufacturers of high risk devices will have to perform clinical investigations, and the results of these will have to be published on an accessible database.
If a company is to …