- Sale of Medical Devices in the European Union: The Medical Device Directive
- May 5, 2003 | Author: Barbara Müller
- Law Firm: Fredrikson & Byron, P.A. - Minneapolis Office
Medical Devices certified by the European Union with a CE marking in any European Union member state gain access to one-third of the world market.1 The basic requirements a device must fulfill to receive the CE marking of conformity are contained in Council Directive 93/42/EEC from June 14, 1993, known as the Medical Device Directive. The MDD was enacted into national law in the EU member states. By having its device certified in any one of the 14 EU member states, a manufacturer gains access to the market in all of the states.
The MDD uses FDA certification procedures as a model, and compliance with FDA requirements may also satisfy the essential requirements for EU certification. Because certification in the U.S. generally takes two or three times longer than in the European Union, U.S. manufacturers may be able to first start selling their products in the European Union. Basic knowledge of the MDD and its requirements may have concrete effects on the balance sheet of the manufacturer who knows how to take advantage of the directive.
Conformity assessment procedures for CE marking are carried out by various bodies within the member states of the European Union. Since each member state must notify both the European Commission and the other member states of the bodies within its territory that it has designated for carrying out these tasks, they are referred to as notified bodies. One German notified body, the TÜV, has a subsidiary in Minnesota to facilitate certification procedures for medical device manufacturers in the Midwest.
Manufacturers who do not have a registered place of business in any member state of the European Union must appoint an authorized representative to place a device on the market. The authorized representative must submit medical device reports on behalf of the manufacturer and be available to interact with the manufacturer, the European authorities, and the notified body. The representative may even face liability claims from alleged product malfunctions.
Some manufacturers choose to appoint one of their European distributors as authorized representative. This has the advantage of using existing business relationships. However, problems may arise if the manufacturer wants to terminate its relationship with a distributor that also serves as authorized representative. Because the authorized representative's name must appear on the device's label, products carrying the distributor's name may be on the market long after that relationship has been terminated. Moreover, the appointment of one distributor might give rise to problems with distributors appointed for other European states who might perceive themselves as being second-class distributors.
Some manufacturers choose to work with independent companies that specialize in providing services as authorized representatives. These companies provide specialized expertise on the Medical Device Directive and cooperation with national and European bodies. However, manufacturers should pay specific attention to the contracts by which they appoint such a company as authorized representative. Provisions indemnifying the authorized representative from and against all claims and liabilities that might arise are generally included.
Manufacturers with a branch or subsidiary in a European Union member state do not have to appoint an authorized representative since they have a registered place of business in the European Union. Manufacturers must carefully balance the cost of establishing such an independent branch or a subsidiary with the cost of appointing an authorized representative, whether the manufacturer's distributor or an independent company.
Requirements for medical devices exported into the European Union vary according to whether they are intended for clinical investigation or sale.
CE marking is not required if the product is meant only for clinical investigation within the European Union. Instead, a statement is filed detailing the investigation plan, general description of the device, design drawings, and opinion of the relevant ethics committee. The competent authorities of the member states in which the investigations are to be conducted must also be notified.
The CE marking of conformity is required for medical devices that are neither custom made nor intended for clinical investigations before they can be placed on the market. Annex I to the directive details the essential requirements the medical device must meet. Annex II specifies the full quality assurance system for the design, manufacture and final inspection of the device. Annex III addresses the EC Type-Examination whereby a notified body ascertains and certifies that a representative sample of the production fulfills the relevant provisions of the MDD.
On May 18, 1998, representatives of the United States and the European Community signed the Agreement on Mutual Recognition which covers medical devices. The goal of this agreement is to achieve the mutual recognition of conformity assessment procedures. If a medical device received the CE marking because a notified body reached the conclusion that the device complied with all applicable provisions of the MDD, the FDA would accept or recognize the results. The agreement still needs to be ratified by the U.S. and the member states of the EU. When the procedures for entry into force of the agreement are completed, the U.S. and the European Union will exchange letters of confirmation. The agreement then will enter into force on the first day of the second month following the date on which these letters were exchanged. After a transition period of three years, the mutual exchange and endorsement of quality system evaluation reports and product evaluation reports will begin.
Understanding the Medical Device Directive is essential for the successful introduction of medical devices into the European Union. This article can provide only a very general overview of the directive and its requirements. Details must be discussed on a case-by-case basis.