(6) ‘companion diagnostic’ means a device specifically intended to select patients with a previously diagnosed condition or predisposition as eligible for a targeted therapy;

(6) ‘companion diagnostic’ means a device specifically intended for and essential to the selection of patients with a previously diagnosed condition or predisposition as suitable or unsuitable for a specific therapy with a medicinal product or a range of medicinal products ;

Community legislation on the manufacture of derived products intended for use as cosmetic products, medicinal products or medical devices comprises a comprehensive framework for the placing on the market of such products: Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products , Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products , Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member St ...[+++]ates relating to active implantable medical devices , Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (the specific Directives).

Community legislation on the manufacture of derived products intended for use as cosmetic products, medicinal products or medical devices comprises a comprehensive framework for the placing on the market of such products: Council Directive 76/768/EEC of 27 July 1976 on the approximation of laws of the Member States relating to cosmetic products , Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use , Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products , Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member St ...[+++]ates relating to active implantable medical devices , Council Directive 93/42/EEC of 14 June 1993 concerning medical devices and Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (the specific Directives).

(3) Technical measures for the type-approval, as separate technical units, of replacement catalytic converters to ensure both their emissions performance and, where appropriate, their compatibility with the on-board diagnostic (OBD) system of the vehicle for which they are designed, should be introduced.

The legislation does not apply to active implantable devices or those used for in vitro diagnosis, medicinal products for human use, cosmetics, human blood products or transplants, tissues or cells of human or animal origin, or personal protective equipment.