21.9.2007 Official Journal of the European Union L 247)21 DIRECTIVE 2007/47EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Commu- nity, and in particular Article 95 thereof, Having regard to the proposal from the Commission, Having regard to the opinion of the European Economic and Social Committee (1), Acting in accordance with the procedure laid down in Article 251 of the Treaty (3, Whereas: 1 Council Directive 93/42[EEC () requires the Commission to submit a report to the Council, no later than five years from the date of implementation of that Directive, concerning: (i) information on incidents occurring follow- ing the placing of devices on the market, (ii) clinical investigation carried out in accordance with the procedure set out in Annex VII to Directive 93/42/EEC, and (i) design examination and EC type examination of medical devices that incorporate, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in 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 (%) and which is liable to act upon the body with action ancillary to that of the device. The Commission brought forward the conclusions of that report in its Communication to the Council and the European Parliament on medical devices which, at the request of the Member States, was expanded to cover all aspects of the Community regulatory framework for medical devices. This Communication was welcomed by the Council in its Conclusions on medical devices of 2 December 2003 (°). It 0J C 195, 18.8.2006, p. 14. Opinion of the European Parliament of 29 March 2007 (not yet published in the Official Journal) and Council Decision of 23 July 2007. OJ L 169, 12.7.1993, p. 1. Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ L 284, 31.10.2003, p. 1). O] L 311, 28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council (O] L 378, 27.12.2006, p. 1). O] C 20, 24.1.2004, p. 1. was also discussed by the European Parliament which on 3 June 2003 adopted a resolution on the health implications of Directive 93/42/EEC (°). Following from the conclusions drawn in that Commu- nication it is necessary and appropriate to amend Council Directive 90/385/EEC (’), Directive 93/42/EEC and Direc- tive 98/8/EC of the European Parliament and of the Council (3). To ensure consistency of interpretation and implementation between Directives 93/42/EEC and 90/385/EEC the legal framework related to issues such as authorised representa- tive, the European databank, health protection measures, and the application of Directive 93/42[EEC as regards medical devices incorporating stable derivates of human blood or human plasma, as introduced by Directive 2000/ 70/EC (%), should be extended to Directive 90/385/EEC. The application of the provisions on medical devices incorpor- ating stable derivates of human blood or human plasma includes application of Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (19). It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Software for general purposes when used in a healthcare setting is not a medical device. Particular care should be taken to ensure that the reprocessing of medical devices does not endanger patients’ safety or health. It is therefore necessary to provide clarification on the definition of the term ‘single use’, as well as to make provision for uniform labelling and OJ C 68 E, 18.3.2004, p. 85. OJ L 189, 20.7.1990, p. 17. Directive as last amended by Regulation (EC) No 1882/2003. OJ L 123, 24.4.1998, p. 1. Directive as last amended by Commission Directive 2007/20[EC (OJ L 94, 4.4.2007, p. 23). Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/ EEC as regards medical devices incorporating stable derivates of human blood or human plasma (OJ L 313, 13.12.2000, p. 22). (19 OJ L 33, 8.2.2003, p. 30.