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This article was originally published in The Gray Sheet

Executive Summary

Adverse incident reporting would be required for all medical devices, including low risk products placed in Class I, according to the European Community Council of Ministers' "common position" for a "medical devices" directive. Previous drafts of the directive would have required reporting for only Class IIa, Class IIb, and Class III devices. The common position, which was agreed to in February, calls for EC member states to process "any information brought to their knowledge" regarding adverse incidents involving a "Class I, IIa, IIb or III device." The medical devices directive outlines a regulatory program for nonactive (nonelectrical) medical devices and nonimplantable active medical devices. A seventh draft of guidelines for a reporting or "vigilance" program was recently released. The guidelines currently apply only to devices subject to the active implantable medical devices directive, which went into effect Jan. 1. Reporting time frames outlined in the most recent draft differ from early versions of the guidelines ("The Gray Sheet" Sept. 23, 1991, p. 11). The seventh draft states that all adverse incidents must be reported in 10 days and that "near incidents" must be reported in 30 days. The Council's "common position" was referred to the European Parliament on March 9 for a second review. After the Parliament considers the directive, it will be returned to the Council for final approval, which is expected in late 1993. The document is slated to go into effect on Jan. 1, 1995, with a five year transition period during which manufacturers can either comply with the directive or with existing requirements of member states. Expansion of incident reporting requirements was one of several revisions the Council made to a directive proposed by the EC Commission in July ("The Gray Sheet" Oct. 12, p. 7). The modifications will be spelled out in Commission and Council reports on the directive that should be delivered to Parliament in the next several weeks. A clause affecting reimbursement for devices was among the provisions modified by the Council. The common position deletes language intended to encourage uniform reimbursement practices by EC member states that was strongly supported by the medical device industry. The language eliminated said that "Member States may determine which categories and types of devices are eligible for reimbursement under...public health and sickness insurance schemes, but once those categories and types of device are determined, all devices within those categories or of those types which comply with the provisions of this present directive should in principle be reimbursable under such public health and insurance schemes." No substitute language was included in the common position. In addition, the directive revises the provision covering combination products in which the device and drug components form a "single unit." The latest version states that such products will be covered primarily by the pharmaceutical directive, 65/65/EEC, with the device directive applying "as far as safety and performance related device features are concerned." The previous version of the device directive stated that the device component would be covered by the device directive, the drug component by the pharmaceutical directive. The directive also refines the definition of a single unit hybrid product, stating it is a product in which "the device and medicinal product form a single integral unit which is intended exclusively for use in the given combination, and which is not reusable." Two other types of combination products are covered by the directive: those in which "a device is intended to administer a medicinal product," and those in which "a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product...and which is liable to act upon the body with action ancillary to that of the device." The document exempts products derived from human and most animal tissue from regulation under the directive. Specifically, the directive states that requirements will not apply to "transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin." Also exempted are "transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue." The document also eliminates provisions calling for creation of an EC device directive register. Plans for a register "containing the necessary information for consistent implementation of" the device directive had been included in earlier versions. The directive also moves diagnostic x-ray equipment from Class IIa to Class IIb, the same class as therapeutic x-ray devices. The National Electrical Manufacturers Association does not support the change. It believes that Class IIb is overly stringent for diagnostic x-ray products. NEMA says the provision is not likely to be change before the directive is finalized.

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