Medical Device Link.

Originally Published MDDI January 2002

NEWS & ANALYSIS

Several European conformity assessment bodies active in the medical device and diagnostics sector have formed a trade association. The European Association of Notified Bodies for Medical Devices (EA NB-MED) made the announcement on November 6 and hopes to be fully operational by April 2002. At the time of writing, 23 testing and certification organizations, representing more than 80% of worldwide medical device certification activity by notified bodies, had agreed to join the association.

There are approximately 60 such organizations that conduct audits in accordance with the three medical device directives and authorize manufacturers to affix the CE mark to their devices.

One of the aims of the organization, which will be headquartered in Brussels, is to improve communications among the European Commission, industry, the competent authorities (which designate and oversee the notified bodies), and user groups by acting as a focal point and a single voice for its members. EA NB-MED also lists among its primary objectives the protection of the legal and commercial interests of its member groups and the promotion of high technical and ethical standards.

The latter has been a bone of contention with industry, which has questioned the technical competence of some notified bodies to evaluate properly a broad range of devices. Documentation requirements and certification procedures that vary from one organization to the next have also been a concern in the past. Chris Jepson, product certification manager at the UK-based notified body SGS Yarsley and a member of the provisional management team of EA NB-MED, believes that the association can be an effective mechanism for resolving such issues.

It's premature to provide any specifics, says Jepson, "but we would certainly encourage robust auditing of the notified bodies." The association could serve as a forum when the different technical approaches to a question are resolved, he adds. "We all want the notified bodies to set high standards, to be consistent, and to avoid situations in which one notified body is in the position of handing out a certificate whereas another is not. That is part of the rationale of the association," he says.

Jepson concedes that EA NB-MED will not succeed in signing up all of Europe's notified bodies. "There are a few that work in very specialized areas. They feel that they don't have much in common with the others," he says. "And there are some that are effectively state-run organizations, which might feel uncomfortable belonging to a commercial association." Nevertheless, Jepson feels that the association can legitimately make the claim that it "easily represents the majority of [medical device certification] activity."

The new EA NB-MED should not be confused with the Notified Bodies Coordination Group, a tripartite forum in which testing and certification organizations, regulators from the European Commission, and industry convene to draw up technical recommendations. "The tripartite forum is very useful for reaching a consensus, and we do not wish to undermine it in any way," explains Jepson. "But it is not a forum that deals with issues specific to notified bodies organizational problems or questions of legality, for example. Other stakeholders in the medical device industry have their organizations, such as EUCOMED, and it has been felt for some time that testing and certification organizations should have a similar body," says Jepson.

Under EA NB-MED's current provisional structure, Françoise Schlemmer of Qua Sys (Liège, Belgium) is president and operates the secretariat. Jepson is joined by Eugenie Husebye (DNV; Høvik, Norway), Werner Kexel (Eurocat; Darmstadt, Germany), and Gero Viola (TÜV; Berlin) on the provisional management team.

Norbert Sparrow

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