European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas.

At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone to be implanted in thousands of women. French manufacturer Poly Implant Prothese SA, known as PIP, was liquidated in 2010 after French authorities banned the company’s implants, responding to complaints that they were leaking industrial silicone inside plants. Investigating authorities determined that a supplier, warned in advance of an impending inspection, had substituted a medically approved gel for the industrial variety when officials visited the plant, and then returned to use of the industrial-grade product.

Understanding the growing concern among US manufacturers requires a brief summary of the European bureaucratic oversight proposed for high-risk medical devices.

The controversy and call for action which accompanied the breast implant scandal led to passage of a much-debated “compromise amendment” by the ENVI Committee, which would apply to Class III medical devices and implantable devices, among others. For the impacted medical devices, a proposed “conformity assessment procedure” would include the intervention of specialized, notified bodies designated by the European Medicines Agency on the basis of specific staff qualifications and training. These agencies would be required to notify the European Commission of any applications for conformity assessment received from manufacturers concerning high-risk medical devices. The Commission would then be required to promptly transmit the notification and related document package to a yet-to-be-created “Assessment Committee for Medical Devices”. Assuming the Assessment Committee is created, funded, organized and implemented, it would then provide an opinion on the “preliminary conformity assessment”, and most particularly on the reliability of clinical data related to the medical devices “on a case-by-case basis and taking into account … cases of novel devices or devices for which a novel technology is being used.”

American medical device manufacturers view these developments with concern including but certainly not limited to product safety and funding, and their concerns are shared by European manufacturers as well. Traditionally, American manufacturers have relied upon a less-demanding European approval process to permit evaluation of product performance, and development of clinical data, which would eventually support their subsequent requests for approval in the United States – the world’s most profitable health care market. By one estimate, roughly one-fourth of all devices submitted for approval by the US Food and Drug Administration are either rejected by the FDA or withdrawn, at a cost of millions of dollars to their sponsoring manufacturers. With tighter regulations governing the foreign approval process, US manufacturers worry that the funding sources for high-risk medical devices may also become more conservative in their approach to a more closely regulated marketplace. On a related note, the European Medical Technology Industry Association (EUCOMED) reacted to the proposed legislation – which remains subject to further debate later this year – by stating that the Committee “voted in favor of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralized pre-marketing authorization system.”

In summary, it appears likely that the European approval process for high-risk medical devices will be impacted and tightened by new regulations at some point in the future, but the growing chorus of manufacturers – foreign and domestic – upset with the proposed new bureaucracy may yet influence the measures ultimately approved by the European Union.

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