Medical Device Link.

Originally Published MDDI June 2003

NEWSTRENDS

Jeanette Marchant

Participants in Eucomed’s Technical Forum included (from top to bottom) Maurice Wagner, Eucomed director-general; Richard Moore, scientific director; and Dario Pirovano, regulatory affairs director.

Medical device makers that sell combination products in Europe can breathe a sigh of relief. A European Union (EU) decision not to regulate these products as drugs was one of several developments reported at a recent European Confederation of Medical Devices Associations (EUCOMED) Technical Forum. Still up in the air is the classification status of certain medium-risk devices.

The device industry group’s forum took place on April 30 in Brussels. 

Eucomed’s director-general, Maurice Wagner, delivered the good news about combination products. The European Commission recently published an updated proposal for a new regulatory framework for drugs. A previous version had failed to make a distinction between a product’s “ancillary” and “primary” modes of action. 

This could have meant that products ranging from disinfectant wound dressings to antibiotic-coated urinary catheters would have been regulated as drugs rather than medical devices. However, the Commission has clarified the scope of the new rule. It will apply only to products that have pharmacological effects as their primary intended mode of action. It thus excludes devices in which a drug is secondary to the main mode of action. 

The Commission also rejected an amendment introduced by the Parliament that would have given the European Medicines Evaluation Agency the power to determine the scope of the proposed drug directive. The revised proposal was adopted on April 3, 2003.

The Commission’s draft drug regulation will eventually go back to the Parliament for a second reading. Its passage will be watched closely by the European medical device industry. For the time being, however, it appears that combination devices will continue to be regulated under the Medical Devices Directive. The device directive itself is undergoing major review. A revised version should be ready for review this month; new legislation may be proposed as early as 2004. 

One of the more complicated issues being addressed is reclassification of devices. The directive’s mechanisms for reclassification have never been used. Although breast implants were reclassified into Class III, this was done under the directive’s safeguard clause. Now, there is a request from the UK and France to reclassify total hip joint replacements. Speaking at the forum, Quintiles Consulting’s Mika Reinikainen explained that this new effort will create a precedent for working within the framework of the directive. Reinikainen is chairman of the Eucomed task force on reclassification. 

The proposed reclassification would move total joint replacements from Class IIb (medium- to high-risk devices) to Class III (high risk). The UK has also proposed placing all central nervous system (CNS) devices in Class III. Under this proposal, no distinction would be made for devices used transiently (less than 60 minutes) or short term. 

Reinikainen said the request has to be “duly substantiated.” Reclassification, he added, should be done on a case-by-case basis. “There has to be a safety problem for something to be reclassified,” he explained. “Reclassification has to provide a solution to the problem.” In the hip joint case, he argued, reclassifying all total joint replacements will not help. “To impose systematic design dossier examination on these products will not reveal the kinds of problems that we have had.” For example, he said, manufacturing and sterilization problems would not be found through the design evaluation required of Class III products. 

Furthermore, Eucomed’s Dario Pirovano pointed out that reclassifying hip joints would be costly for manufacturers, especially if they have to change their notified body. In Italy, for example, there is only one that can handle Class III products. 

Better differentiation between Class IIa, IIb, and III devices is needed, said Pirovano. “If we are able to give a reasonable, intelligent way to deal with Annex II for Class IIb products, we are likely to be less involved in the systematic reclassification of products.” At the same time, he said, confidence in CE marking would increase.

Reinikainen urged makers of CNS devices used transiently to help Eucomed’s task force argue for reclassification to be done on a case-by-case basis. Although the law provides the industry with little power, the task force plans to push for the process at the next Commission meeting on June 24. 

Other issues discussed at the Technical Forum included early-stage plans for regulating tissue products and the need for greater openness in European device regulation. For more details, visit www.devicelink.com/emdm. 

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