Proposed Medical Device Regulation Too Lax, Say NICE and German Researchers

May 8, 2013 – 10:45 am

Citing the relatively limited amount of clinical evidence needed to CE mark a medical device and lessons learned from the Pip breast implant scandal, Bruce Campbell and colleagues from the National Institute for Health and Care Excellence (NICE) are calling for a more robust regulatory environment in the current issue of BMJ. In particular, they recommend a rigorous device tracking system, improved coding for new procedures, effective use of registers and data linkage and more invasive postmarketing surveillance to fill what they perceive to be gaps in the proposed device regulation that is currently before the European Parliament.

Data acquisition is a primary concern of the authors. “Developing the systems we have described [in the article] would go a long way towards producing observational data that would enhance the safety of devices and procedures and facilitate decisions about their place in healthcare,” they write in BMJ.

In an accompanying commentary, a research group led by Edmund Neugebauer at Herdecke University in Germany takes it a step further by calling for a “central, transparent and evidence-based regulation process for devices.” In April, the group petitioned European institutions to enforce rigorous clinical evaluation and centralise regulatory oversight through a “new public body similar to the European Medicines Agency.”

Many of these suggestions are anathema to the medical device industry, which has strongly cautioned legislators by way of associations such as Eucomed from abandoning the “new approach” to medical device regulations. To press the point, Eucomed has launched the “Don’t Lose the 3” campaign to draw attention to the fact that many medical devices are placed on the market in Europe, on average, three to five years sooner than in the United States.

Related content:

ENVI Committee Hosts Public Hearing on Proposed Medical Device Regulation

BVMed Suggests Immediate Action to Improve Medical Device Regulation in Europe

EU Court of Justice Rules on Definition of a Medical Device

 — Norbert Sparrow

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