CHAPTER 29 Frederique Gouriet Faculty of Medicine, Aix-Marseille Université, Marseille, France The ANSM (Agence Nationale de Sécurité du Médicament et des produits de Santé’s) mission is to ensure the protection of health and safety to health products including those for in vitro diagnostic use. The European Directive 98/79/EC regulates in vitro diagnostic medical devices (IVDMDs) and allows the harmonization within the European Union contributing to the process of commercialization for these devices. Since June 7, 2000, the European Directive 98/79/EC of October 27, 1998 on IVDMD’s [1] came into effect and allows the free movement of such devices throughout the European Community. Prior to commercialization, the manufacturer must obtain the Conformité Européenne (CE) marking on the device, ensuring compliance with the essential requirements of the Directive. The scope of the devices covered by Directive 98/79/EC is defined in Article I of the Directive and integrates these features to an end medical diagnosis from a human sample. Thus, the scope of products covered by this Directive covers all medical devices related to in vitro diagnosis, including reagents, laboratory automation, sample tubes, and accessories specifically designed for in vitro diagnostic use. It also covers the self-tests and devices that may be used in the care or medical practice to carry out an analysis by a health professional. The principle of this Directive is based on the obligation of manufacturers to comply with the essential requirements of design, manufacture, and performance in order to obtain the CE mark for their devices. However, the procedure depends on the CE device. Thus, for the majority of IVDMDs, compliance with these requirements allows the manufacturer to obtain the CE marking under his sole responsibility. For others, including self-tests and devices listed in Appendix II (please refer to Chapter 31 for selected examples) of the Directive (mainly for transfusion or maternal–fetal infection), the manufacturer cannot certify their conformity by itself. They must obtain a certificate of conformity issued by a notified body chosen in a Member State of the European Union. It is up to the competent authorities in each country to identify and control these devices. In France, the competent authority (ANSM) will notify the LNE (Laboratoire National de Metrologie et d’Essais)/G-MED (Groupement pour l’évaluation des dispositifs médicaux) as the certification body in the medical field. In the certification process, the manufacturer may rely on existing standards, especially the harmonized European standards. When a product is designed, manufactured, and evaluated according to one or more harmonized standards, it is compliant with the essential requirements set out in the Directive. For the products listed in Appendix II A (please refer to Chapter 31 for some specific examples), there are specific performance evaluations called common technical specification standards; manufacturers are required to follow these, unlike harmonized standards, which are not mandatory. It should be noted that manufacturers that do not have their registered office in the European Union are required to appoint an agent with a registered office in an EU country. This office can then represent the manufacturer and address any issues from authorities and those in the European Community instead of the manufacturer directly. These are obligations and requirements of Directive 98/79/EC. The European Directive was enacted into French law by Order No. 2001-198 of March 1, 2001. The decrees implemented the European text and specify the rules for the commercialization of devices, and enforceability of manufacturer requirements with offices in France. The manufacturers based in other European countries are subject to the rules in their own countries resulting from the enactment and implementation of the directive into their national law. Under the decree of February 25, 2005 of the Code of Public Health, any operator in France that is a manufacturer, agent, distributor, importer, or subcontractor, has an obligation to declare their activity. French manufacturers and agents must register as responsible for the commercialization. Manufacturers, agents, and distributors outside France, that is to say, any manufacturer that brings IVDMDs into France, must declare their device to the ANSM. According to the European Directive, manufacturers assume the responsibility for the marketing of their devices. They ensure quality by using procedures that they implement in their design, in their manufacture, and the validation of their performance. The role of monitoring and controlling their product comes afterwards. Thus, besides its role in receiving information relating to the commercialization of products that are CE marked and according to the needs related to public health requirements, the ANSM may establish ad hoc requirements. For example, it may ask the manufacturer or any other subsidiary that has been documented to carry the CE marking, for any set of devices, to monitor the performance of the new device entering in the market, to provide additional quality control records or to provide proof of compliance to the requirements listed in the Directive. The manufacturer must also take into account international recommendations when they exist. Moreover, the ANSM organizes a national system of reported incidents called “reactovigilance”. The regulations require that industry, healthcare providers, and other users report any failure or deterioration of any IVDMD that may be fatal to human health. This system is enhanced by the further coordination of the regulatory process required at the European level. The ANSM also participates in various European groups, working on the development of texts, standards, criteria quality, and harmonization of working procedures between countries. Please refer to Chapter 31 for information related to Assessment Procedures and other information related to the European Union requirements for IVDMDs.
Clinical Microbiology In Vitro Diagnostic Medical Devices in France: Regulatory Requirements and Product Information
29.1 Regulatory requirements
29.2 European Directive 98/79/EC
29.3 Directive 98/79/EC in France
29.4 The implications of the regulatory level authorities
29.5 Assessment procedures
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