Medical Device Link.

Oariginally Published EMDM May 2003

A NOTE FROM THE EDITOR

The regulation of medical devices will undergo changes on a number of fronts in the next year. A recent technical forum hosted by EUCOMED provided industry experts with an opportunity to debate some of these issues. Jeanette Marchant attended the event, held in Brussels on 30 April, but our production schedule precludes the publication of her complete report. A summary of her piece is printed below. I encourage you to view the full text of the article on our Web site at www.devicelink.com/emdm. 

Manufacturers of so-called “borderline” products can heave a sigh of relief, writes Marchant. An EU decision not to regulate these products as drugs was one of several developments reported at the forum. EUCOMED’s director-general Maurice Wagner applauded the European Commission’s move to clarify the scope of the proposed drug directive.

In a previous version of the draft, the European Parliament had failed to make a distinction between “ancillary” and “primary” modes of action. As a result, wound dressings with a disinfectant and antibiotic-coated urinary catheters would have been regulated as drugs rather than devices. The text now applies only to products with a primary pharmacological action. Devices in which drugs play a secondary role are exempt.
 
The draft directive will now be considered by the Council of Ministers in June 2003. Once the council has reached a common position, which is not expected until the second half of 2003, the document will go back to the Parliament for a second reading. Its passage will be watched closely by the European medical device industry. It appears, however, that borderline products will continue to be regulated under the Medical Devices Directive (MDD).
 
The directive itself is also undergoing a major review. (The MDD is reevaluated every five years.) The Commission’s first draft of the review is expected to be made available to member states, industry, and other stakeholders in June 2003. New legislation may be proposed as early as 2004. It was noted at the meeting that the Commission has already begun to address specific issues, such as transparency, through ad hoc task forces.
The UK competent authority was among the first to call for more transparency among regulatory bodies. Greater openness is deemed important to improve political and public confidence in the system.

“There is a . . . need to enhance public confidence in the regulatory system,” noted Roland Gérard (St. Jude Medical), a member of the ad hoc expert working group on transparency. “But member states recognize that there would be many difficulties in establishing an EU notified body public assessment report,” he added. Respecting confidentiality obligations is one of several issues that would need to be addressed.

A one-year pilot study of manufacturers’ public assessment reports intends to iron out some of these wrinkles. Details are sketchy, but it appears that the programme will be voluntary and limited to a few products, not necessarily only Class III devices. Breast and hip implants, cardiovascular and coronary stents, and one as-yet-unspecified active implantable are under consideration. The task force will decide on the content of the report and select the types of devices when it meets on 22 July.

“Do we really think that a report generated by manufacturers and checked by notified bodies is going to increase confidence?” asked Gérard. Users do not trust notified bodies, and information provided by manufacturers may not be viewed as objective. Unlike device information available on US FDA’s Web site, such data would not be checked by the authorities.

Any public assessment report should address the needs of the user, added Gérard. The user is more interested in clinical data than in CE marking, he stressed. Furthermore, industry is sceptical of the authorities’ motives. Transparency, say some, is simply a way to obtain more information on medical device products. Despite industry’s concerns, however, this reporting system may become mandatory.

Norbert Sparrow

Copyright ©2003 European Medical Device Manufacturer