Back in January, Jeff Shuren, M.D., the Director of the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA), made headlines when comparing the European Union’s (EU) regulation of medical devices to FDA’s. When asked by a reporter whether proposed changes to FDA’s 510(k) premarket clearance system were aimed at lessening industry’s premarket burden (more consistent with the European approach), Dr. Shuren quoted a plastic surgeon as saying, “Under the EU system, the public are being used as guinea pigs.” He then added, “we don’t use our people as guinea pigs in the U.S.” While his remarks sparked outrage on the part of his European counterparts, Dr. Shuren’s point has not fallen on completely deaf ears across the pond.
On September 26th, the European Commission released its long-anticipated proposed regulation aimed at overcoming the flaws and gaps in the EU existing regulatory framework, the Medical Device Directive (MDD). One of the system’s flaws stems from the lack of a centralized government approval process. In the United States, if a company wants to bring a medical device to market, it must meet FDA’s requirements – including, in the case of most Class II and Class III devices, obtaining premarket clearance or approval from FDA that its device is safe and effective for its intended use. Conversely, in the EU, if a company wants to bring a medical device to market, it pays a notified body (i.e., a private company certified by a European Member State) to conduct a conformity assessment and review documentation demonstrating the device’s safety and quality.
It is not so much that the company pays for the notified body’s services – as even in the US, companies have been paying user fees for FDA to review their applications for years – it is that notified bodies do not consistently interpret and apply the standards set forth in the MDD. In addition, the competent authorities in each Member State are not necessarily aware that a device has received a CE-mark from a notified body before the product reaches their market. If a safety concern arises once the device is on the market, a coordinated response across Member States is not easy to organize.
One of the benefits of the European regulatory framework is that notified bodies are numerous and, therefore, generally able to perform their premarket duties faster than FDA. This fact, coupled with a lower approval standard for high risk devices, has led some to characterize the European system as more supportive of innovation and patient access to novel products. However, according to FDA, there is a price to pay for faster approvals supported by less clinical data, and that price is paid by European patients. See Unsafe and Ineffective Devices Approved in the EU that were Not Approved in the US, FDA (May 2012).
The European Commission’s proposed Regulation includes several features intended to further strengthen patient safety and respond to criticism of the current regulatory framework. With respect to premarket requirements, several reforms have been proposed, including:
- Stronger supervision of notified bodies by competent authorities;
- Additional authority for notified bodies (e.g., unannounced facility inspections, sample testing);
- Manufacturer submission of a safety and effectiveness summary to a public EU-wide database; and
- Creation of a Medical Device Coordination Group (MDCG) authorized to review notified body preliminary conformity assessments for high-risk devices before such products receive a CE-mark and enter the market.
It is this last “scrutiny mechanism” that has the best chances of catching unsafe, high-risk devices before they harm patients. While the proposal steers clear of creating a centralized government approval process, by establishing the MDCG, the European Commission has attempted to address potential safety concerns and increase collaboration among Member States.
Of course, that is only one side of the story. According to industry, the scrutiny mechanism will only deter innovation and slow patient access to novel technologies. As the proposed Regulation is just now entering the legislative phase with the European Parliament and Council, it remains to be seen how the EU will ultimately balance the safety of its patients with the concerns of its manufacturers.