In a major development for the EU medical device sector, the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) voted Wednesday (25 September 2013) in favor of a tougher new regulatory framework that would require some devices to go through a pre-market assessment process by the European Medicines Agency (EMA).

The Basics

The proposal would make several major changes to the way devices are now regulated in the EU. Currently, devices are regulated through a decentralized CE-marking system largely administered by notified bodies and overseen by individual EU member states.

Under the new system, medical devices would be subject to a system more similar in concept to the US Food and Drug Administration's Premarket Application (PMA) process. Most implantable devices would need to conduct randomized clinical trials, and high-risk medical devices would need to go through a premarketing authorization system administered by EMA.

Industry critics have questioned whether EMA has the capacity to regulate high-risk devices, of which hundreds are introduced onto the EU market each year. ENVI's proposal calls for an advisory board of experts to oversee their regulation, similar to EMA's current drug advisory boards (e.g. CHMP). A lack of regulatory capacity could lead to delays for devices entering the EU market, leading to a costlier development process.

The advisory board concept immediately received a sharp rebuke from some in industry. Device industry group Eucomed released a statement calling the committee "Kafkaesque," noting the involvement of more than 600 medical experts across 21 subcommittees. "No assessment has been made of any kind as to what real safety gains there would be, what delays it would cause for lifesaving devices reaching patients and what the exact cost of the added bureaucracy to European governments and industry will be," the group wrote.

For ENVI, however, the costs are worth the benefits. "We really needed to put patient safety first and to bring transparency to an industry that is quite unregulated," said rapporteur Dagmar Roth-Behrendt, who authored the draft of the proposal. She added that she hoped the European Commission, which must still approve the proposal, would not "dilute" the "improvements" made to the device directive in the form of hundreds of amendments. The commission is set to vote on the proposal on 22 October 2013 during a plenary session.

Also passed on Wednesday was a proposal to more tightly regulate in vitro diagnostics. While not going as far as the medical device proposal, it nevertheless calls for the involvement of ethics committees, informed consent provisions, and a ban on direct-to-consumer genetic testing with respect to IVDs.

Potentially Negative Effects

The changes were in response to a number of high-profile medical device failures in recent years, including metal-on-metal hips and deficient breast implants manufactured by now-defunct French manufacturer Poly Implant Prothese. Proponents of the rule said more stringent reforms would act to enhance device quality and efficacy, benefiting consumers.

Opponents of the changes, however, have been vocal in pointing out a number of perceived flaws. Device group Eucomed, for example, has cited the EU's competitive advantage relative to the US, noting that many devices launch in the former three to five years in advance of the latter.

In an updated statement released on 25 September, Eucomed reiterated those concerns, stating that the vote was "in favour of an extreme heavy bureaucratic procedure which combines a complex, unpredictable scrutiny process with a de facto case-by-case centralised pre-marketing authorization system. The proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe's 25,000 small and medium-sized device makers."

Erik Vollebregt, a widely-cited expert on EU medical device matters, also weighed in on the passage, saying the vote marked the passage of industry's "worst-case scenario."

"ENVI did today what only happens in your worst nightmare: take several compromises and mash that into a compromise of compromises that cannot possibly work effectively," Vollebregt wrote.

ENVI Statement

Eucomed Statement

Vollebregt Statement