Du coeur artificiel au pansement en passant par les prothèses, lentilles correctrices, fauteuils roulants ou appareils de radiologie, la notion de dispositif médical recouvre un vaste ensemble de produits ayant en commun leur finalité médicale et leur action qui n’est pas obtenue par des moyens pharmacologiques ou immunologiques ni par métabolisme. Les dispositifs médicaux ont été règlementés dans les années 1990 par des directives fondées sur les principes de la nouvelle approche (définition d’exigences essentielles et renvoi à l’harmonisation technique, place importante laissée aux acteurs professionnels et rôle limité conféré aux autorités publiques, évaluation de la conformité des produits par des organismes notifiés et absence d’autorisation de mise sur le marché). Malgré les avantages liés à leur souplesse, ces directives n’ont qu’imparfaitement réussi à garantir la sécurité des dispositifs médicaux, ainsi que cela a été rappelé dans le contexte de l’affaire des prothèses PIP : évaluation clinique, information et traçabilité des produits insuffisantes, contrôle par et sur les organismes notifiés limité, faible coordination entre les autorités, etc. Pour renforcer la sécurité des dispositifs médicaux européens, plutôt qu’une transposition du cadre juridique des médicaments ou des dispositifs médicaux américains, un cadre juridique sur mesure, adapté à leur niveau variable de risque, est à envisager. C’est ce que proposent les règlements qui seront prochainement adoptés. / From artificial heart to bandage through implants, corrective lenses, wheelchairs or radiology devices, the concept of medical device covers a wide range of products having in common their medical purpose and their action which is not obtained by pharmacological, immunological or metabolic means. Medical devices were regulated in the 1990s by directives based on the principles of the new approach (definition of essential requirements and reference to technical harmonization, important role for professional actors and limited role for public authorities, evaluation of the conformity of products by notified bodies and absence of marketing authorization). Despite the advantages of their flexibility, these directives have only partially succeeded in guaranteeing the safety of medical devices, as underlined in the circumstances of PIP implants scandal: limited clinical evaluation, information and traceability of products, limited control by and on notified bodies, lack of coordination between authorities, etc. To strengthen the safety of European medical devices, rather than transposing the legal framework of medicinal products or American medical devices, a custom-made legal framework, adapted to their varying level of risk, is to be considered. This is what the upcoming regulations put forward.

Introduction. This paper discusses the most topical issues of the Biocidal Products Directive (BPD) implementation, in particular, the impact on the social and health safety on various population groups, environmental safety, trade, manufacturing and their prospectives. The Aim of the Study – to evaluate the development of the biocides market and its participants in Lithuania. The Tasks – to evaluate the impact of the approximation of the laws of Lithuania and the European Union, concerning the placing of biocides on the market and its participants. Methods. Based on the "Methodology for impact of the regulatory laws assessment", the study identifies changes in the biocides market and the activity of its participants. A sample survey of manufacturers of biocides and of the users (personal health care institutions and preventive disinfection and disinfestation enterprises) was conducted. The analysis and evaluation of the available biocides database was also undertaken and SPSS statistics software was used to measure the statistical significance of the results. The market was assessed by the application of the criteria laid down in the BPD, in particular, the number of authorized biocides, distribution of product types, distribution of biocides according to categories of users, distribution of use of identified and notified active substances of biocides. Results. The study demonstrated that the Lithuanian biocides market has changed following the implementation of the BPD:... [to full text]