BMJ: Medical device regulation not strong enough

Proposals for the European Union to change the way it regulates medical devices do not go far enough to ensure safe and effective patient care, according to a commentary published online on 7 May in the British Medical Journal (BMJ).

Within Europe, regulations require manufacturers to obtain a CE Mark for a new device from any of the many "notified bodies" throughout the EU. But the amount of clinical evidence needed for CE Marking is typically small -- and recent events such as the Poly Implant Prosthèse breast implant scandal show that the process does not go far enough, according to Dr. Bruce Campbell and colleagues at the National Institute for Health and Care Excellence (NICE) in London (BMJ, May 7, 2013).

Data gathering is still not happening as it should, Campbell's team wrote. The group suggested solutions such as device tracking to help trace patients and recall devices; improved coding for new procedures; use of registers and data linkage; and better postmarketing surveillance.

In a related commentary also published in BMJ, a research group led by Edmund Neugebauer, PhD, at Herdecke University in Germany argues that Europe needs "a central, transparent, and evidence-based regulation process for devices."

Neugebauer's team has submitted a petition to the European Commission, European Parliament, and European Council asking these bodies to enforce the rigorous clinical evaluation of medical devices.

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