Full article reprinted from "The Gray Sheet" - July 14, 2007
EU medical device regulation news: Find out why some in the device industry are pushing back against strong suggestions from the European government that it may move toward more aggressive, centralized oversight of medical devices.
The device industry is pushing back against strong suggestions from the European government that it may move toward more aggressive, centralized oversight of medical devices.
The European Commission hinted at this move in a 2005 communiqué to the European Parliament and Council - "Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment" - in which it agreed to simplify four of the nine legal texts governing the safety and performance of medical devices in the European Union.
Nevertheless, many stakeholders were caught off guard when the Commission suggested, in the form of a May 8 public 1questionnaire seeking "2Revamping The Medical Devices Directives" input on several questions and proposals, a recast of the entire framework of Directives governing devices (see chart).
Although the EU executive branch does not see any major changes being finalized in the next five to ten years, the Commission says it is reviewing responses from the questionnaire and will decide on possible future measures after the summer break.
The official deadline for responding to the questionnaire was July 2, but a Commission spokesman told "The Gray Sheet" it will accept responses until the end of the month.
The First Step Toward Pan-Euro Device Regulation?
Devices sold in the European Union are currently governed by three core Directives for active implantable devices, medical devices and in vitro diagnostic devices, plus six modifying or implementing Directives. The EU leaves it up to each of the 27 member states to create their own laws based on the goals of the Directives, resulting in some wide variations from state to state.
Many, particularly within the Commission, have been campaigning for a pan-European device agency. Despite rumors of changes to come, few expected the questionnaire to appear so soon after the EU finalized its first round of revisions to the Medical Devices Directives in 2007.
By comparison those revisions were minor, mostly tightening up provisions, including some relating to device design and clinical trial oversight, product classifications and information-sharing between member states (3"The Gray Sheet" June 4, 2007, p. 9).
"The competent authorities were surprised," said Ekkehard Stösslein, deputy head of the medical devices department at the Federal Institute for Drugs and Medical Devices (BfARM), Germany's competent authority.
"Just when we've got all this legislation into force, and I mean within a few months of getting this legislation into force, the community decided to pose a new modification that has caused a great deal of debate in the European community," added Elisabethann Wright, a life sciences attorney in Hogan & Hartson's European bureau, speaking at a regulatory affairs meeting in Irvine, Calif., in June.
Euro Drug Agency Would Review High-Risk Devices
Modernizing and simplifying what some view as an outdated, unruly collection of legislation will be a difficult and lengthy process, Stösslein and Wright agree. The May 8 questionnaire is just a first information gathering step, and an opportunity to gauge where industry and EU member states stand on several key issues.
In particular, the Commission asks stakeholders whether pre-market approval of high-risk devices, such as coronary stents, pacemakers and HIV tests, should fall under a medical device committee within the existing European Medicines Agency (EMEA).
Further, it suggests merging all nine texts into a single regulation, which, unlike the Directives, would be immediately enforced in all member states in precisely the same manner.
BfARM's Stösslein says he favors combining the various Directives into a single regulation. But the German regulator doubts that EMEA is the proper vehicle for centralized oversight of medical devices, and would support the creation of a brand new body responsible for medical devices only.
"It's more of a discussion of when it will be implemented than if it will be implemented," Stösslein said of a centralized reviewing institution at the June 11-12 regulatory affairs meeting.
The European device industry takes particular issue with extending EMEA's authority to certain medical devices because industry says it lacks device expertise and charges fees significantly higher than the current costs of medical device oversight, which is largely conducted through audits by non-governmental notified bodies within the member states.
Expanded EMEA oversight would apply to only a small subset of products, but "the way in which EU institutions receive power is starting with small steps," notes Linda Horton, a partner at Hogan & Hartson. "I think the European medical device industry groups know this well and see this as a threat."
Proponents say that EMEA has had success with pre-market review of drugs, and if properly funded, could buy the expertise to regulate devices as well.
If the proposal did go forward, EMEA "would need to be significantly restructured so that any medical device related function were autonomous and not subservient to the pharmaceuticals functions it already has," European trade association Eucomed said in its response to the Commission.
The current regulatory framework, however, is working fine, industry stressed in a joint position paper released July 2 by seven European trade associations representing 95% of the European device industry.
They called the recast "premature," suggesting the Commission should have waited to assess the impact of the 2007 revisions and full implementation of Eudamed, the European medical devices database in development for years, which should occur by 2012 at the latest.
"Eucomed had a good point when they said 'You're saying this revision is necessary for public health concerns; we just finished the last revision of the Medical Device Directives and there were no public health concerns raised then. Where have these public health concerns come from?'" Hogan & Hartson's Wright told "The Gray Sheet."
"Arguably, the Commission kind of got off on the wrong foot, first of all because they put one revision out so quickly following the other one. Second, this new revision - people had started discussing it before the previous revision had even been completed."
The EU Commission says that since 2005 there have been "a number of drivers" for going beyond strengthening a few Directives to "a strengthening of the whole legal framework to give as high a level of protection of public health as possible."
"The current system does not always offer a uniform level of protection of public health in the European Union," the Commission says in its preamble to the questionnaire. "New and emerging technologies have challenged the current framework, highlighting gaps and pointing to a certain scarcity of expertise."
Notified Body Reforms A Must
Industry is not opposed to every idea put forth in the questionnaire. Namely, companies support proposals to reform the way notified bodies are designated and monitored to ensure consistency across the entire European community.
The questionnaire suggests that notified bodies should be designated and monitored in a more standardized way. It seeks input on whether a unified interpretation of the notified body's tasks and more transparency into their activities, perhaps developing a system to share information between auditors and member states, is necessary.
According to Paul Brooks of the international notified body BSI, many notified bodies would favor this approach.
BSI agrees with industry that the regulations are largely working as is, but sees room for improvement in the spirit of better consistency between member states.
"The oversight of the notified bodies is the responsibility of the individual member states of the European Union, and the way the member states discharge those responsibilities don't seem to be consistent," Brooks said in an interview.
Proposals such as standardized accreditation and mandatory annual reports on notified body performance "would help raise confidence about the quality of the work being conducted by the notified bodies and the integrity of the work," he explained.
The reports would not likely share confidential information about individual manufacturers, but they could give insight into the types of reviews being conducted, the products being reviewed and the skill sets of notified body staff.
Standardized accreditation could be achieved either by establishing criteria that member states would use to designate and monitor notified bodies, or by designating a central oversight group to make recommendations about which notified bodies should be given the green light, Brooks suggests.
BSI also shares industry's concerns about delegating device oversight to the European Medicines Agency. "The device competence and expertise really doesn't exist within EMEA."
Notified bodies have developed extensive expertise in medical device oversight, which no other European agency possesses, Brooks notes.
But this may not be true across the board, notes Linda Horton of Hogan & Hartson. "On the high-tech end, the European system is challenging. Some of our clients don't have that many choices of notified bodies they can go to because of expertise issues," she said.
"If the product is novel or if the product is a combination, they can run into a difficulty finding a notified body that will agree that it has competence. Sometimes notified bodies assert they can competently review the technology, but then they kind of fall down on the job."
Government, Industry Want Global Harmonization
Ultimately, the European Commission's goal in restructuring the device directives would be not only to keep pace with increasingly complex technologies, but to harmonize its regulatory efforts with the rest of the world
Right now, "you have the European procedure, you have the U.S. procedure, you have the Japanese procedure," Wright noted. "They're all different; the obligations are different. Sometimes, the classification of the product is different. A product can be classified in the U.S. as a medical device and in the EU as a medical product - two completely different authorization procedures."
Diverse stakeholders, from industry to member states to the European Commission, favor closer alignment with international models of regulation, along the Global Harmonization Task Force model.
"Europe is only one of a number of big trading blocks in the world," Wright said. "The closer that the legislative approach to medical devices ... can become harmonized between the major trading blocks, the better it is for everyone."
- Jessica Bylander
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