The European Commission says it will move ahead with plans to overhaul the European Union's medical device regulatory framework next year, and hopes to impose a "modern set of rules" by 2015.
Last summer, the commission unveiled controversial plans to rework and centralize the European framework of medical device regulation, contained in several legal texts collectively termed the Medical Device Directives (MDD).
The commission received hundreds of comments on its proposal (1"The Gray Sheet" July 14, 2008, p. 5). To the relief of the device industry, implementation was ultimately postponed. Nevertheless, there is momentum in the European body to pursue the so-called "recast," though under a new administration.
European citizens will vote this week for new members of the European Parliament, who will begin their five-year terms at the beginning of 2010. The legislators play a role in appointing members to the executive-branch European Commission.
"We will eventually deliver, under the new commission, a broader revision of the medical devices regulations in Europe," Georgette Lalis, director of the European Commission consumer products and industry division, affirmed May 26 at an international device industry meeting in Rome.
Lalis says the current administration is urging the new guard to see that "by the end of 2015, Europe will have a modern set of rules in medical devices to support the innovativeness and competitiveness of our industry while assuring the highest possible level of public health and patient safety."
The recast is necessary to address fundamental weaknesses in the current system, Lalis said. "It's now time, we think, to fix them."
European device trade association Eucomed, meanwhile, is drafting its own proposed framework for an MDD overhaul, which it intends to discuss with the commission before public release, Chief Executive John Wilkinson told "The Gray Sheet."
A Single Device Directive, Almost
Devices sold in the European Union are governed by three core directives: for active implantable devices, medical devices and in vitro diagnostic devices, plus six subsidiary directives.
Each of the 27 EU member states then creates its own laws based on the provisions of the directives.
Under the current system, Lalis said, there is too much variation in how notified bodies - the third-party entities responsible for regulatory oversight of devices - evaluate high-risk and novel technologies.
According to the commissioner, the recast will improve the designation and monitoring of notified bodies, and improve the oversight of higher-risk devices throughout Europe - without necessarily requiring pre-market review of all high-risk devices, Lalis stressed.
"We are looking for a mechanism whereby we will be able to guarantee that, throughout Europe, notified bodies evaluate those devices in the same way."
In the interest of simplicity, the recast will merge the different directives texts, excluding the IVD directive, which will be updated separately.
Several of the directives underwent some changes in 2007, but the IVD directive has not been revised since 1998. The 2007 changes were largely "housekeeping" fixes, Lalis said. Member countries must implement those reforms no later than next March (see sidebar: "2In the Meantime...").
Devices Will Not Be Viewed As Drugs - Official
The European Commission intends to centralize device regulatory authority in Europe, though logistical questions remain. Commissioners cannot create a brand new agency, and so are considering expanding the current European Medicines Association (EMEA) to include devices.
"This has created a lot of unrest," Lalis acknowledged. "People felt that we were dangerously converging towards pharmaceuticals in the medical device industry," or that devices would be reviewed by drug experts, "which is not the case."
Aside from fears about blurring the ines between drug and device regulation, industry also worries that devices will not get enough attention under the EMEA scheme, Eucomed's Wilkinson said.
Lalis said the devices branch would be "a separate foot of the agency, equal to the other, with specific resources, with a specific secretariat and a committee composed of medical device experts from member states."
The recast will also address regulatory jurisdiction of combination products, and will decide whether certain unregulated aesthetic implantable devices should be included in the MDD scope.
"We will create a separate definition and separate control mechanisms" for these, Lalis added.
The commission says it is still open to suggestions from industry on how to shape the final recast.
- Jessica Bylander (j.bylander@elsevier.com)
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