EC MEDICAL DEVICE DIRECTIVES' TRANSPOSITION INTO NATIONAL LAW

EC MEDICAL DEVICE DIRECTIVES' TRANSPOSITION INTO NATIONAL LAW is the step in the European Community's push to harmonize its regulations that manufacturers need to watch most closely, Mika Reinikainen, with the D.C. law firm Hogan & Hartson, advised companies attending an Oct. 5 session of the Regulatory Affairs Professionals Society conference in D.C. To date, much of the focus of the harmonization effort has been on the development of directives, which contain procedures to be followed for placing a device on the market. Commenting that the three directives that address European regulations governing medical devices -- the active implantable medical devices, medical devices and in vitro diagnostics directives -- are important to understand because they form the foundation for the system, Reinikainen said they are not the "determinant" texts. "While, ostensibly, [the directives] are the texts that you must follow in order to reach the blessed state of having a CE marking, this is merely not enough because the way the system works...these texts actually have to be transposed into national legislation" with which a product must comply in order to gain market entry, he told RAPS. From the legal standpoint, Reinikainen said, it is the national legislation that manufacturers will be following to get the CE mark, not the directives. To further muddy the regulatory waters, the national laws -- as transposed from the directives -- "will be subject to change and interpretation," Reinikainen said. "Be sure that you interpret these texts correctly, that your interpretation is agreed [to] by the notified body" conducting the assessment of a product for the CE mark. Also be aware that "if you agree with the notified body but you have together made a mistake then...it's very possible that the member state will use the safeguard clause and take your product off the market," he cautioned. Manufacturers must also take into account what technical standards apply to the product being marketed. "That's a further complication and you have to make sure that the standards that you use are up to date," he said. The latest document to clear the European Community Council of Ministers is the medical device directive, adopted in June. Member countries must transpose the directive into national law within six months of the directive's January 1995 effective ("applicable") date. Among the changes made in the final version of the directive is a broadening of the definition of "medical device." The revised text states that a "'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings [emphasis added] for the purpose of: diagnosis, prevention, monitoring, treatment or alleviation of disease, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, investigation, replacement or modification of the anatomy or of a physiological process, [and] control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means." Earlier versions of the directive stated that a medical device is used "on human beings" [emphasis added]. The change reportedly was made to make the definition compatible with the one used in the forthcoming directive on in vitro diagnostics. The IVD directive is slated for adoption in late 1995, or early 1996, with applicability expected in 1997. The first directive to have been adopted by the Council of Ministers was the active implantable medical device directive -- in July 1990. It became applicable this past January. RAPS meeting participants also were updated on the movement toward mutual recognition agreements between the EC and U.S. regarding medical devices. Charles Ludolph, director of the Commerce Department's Office of European Communities Affairs, said that the EC "has preliminarily approved the United States, Canada, New Zealand, Australia and Japan as priority countries for the negotiation of mutual recognition agreements" in various sectors. He added that the EC also "has expressed interest in, among other sectors, medical devices" as a "priority" area for negotiations. Ludolph noted that from the U.S. perspective, the first step toward a mutual recognition agreement is the "successful" completion of the ongoing effort by the U.S., EC, Japan and Canada to develop a harmonized guidance on medical device quality systems ("The Gray Sheet" Feb. 1, p. 3). A draft of the guidance is expected to be unveiled at the Nov. 9-12 Global Medical Device Conference in Tokyo. The second step, Ludolph said, is conducting "a confidence building exercise" toward complete mutual recognition that would involve reaching separate agreements on "blocks" of conformity assessment, such as testing and registration to ISO 9000. With the achievement of these smaller-scale pacts, "confidence is built" that can lead to "mutual recognition of full product approval," Ludolph maintained.