Bibliography
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Official Journal L 331, 07/12/1998:P. 0001 – 0037.
- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices Official Journal L 169, 12/07/1993:P. 0001 – 0043.
- Directive 98/8/EEC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market Official Journal L 123, 24/04/1998:P. 0001 – 0063.
- 2002/364/EC Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices Official Journal L 131, 16/05/2002:P. 0017–0030
- Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC, Official Journal L 396, 30/12/2006:P 0001 – 0849.
- Directive 2006/121/EC of the European Parliament and of the Council of 18 December 2006 amending Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances in order to adapt it to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency, L 396, 30/12/2006:P 0850 – 0856.
- Directive 2002/95/EC of the European Parliament and of the Council of 27 January 2003 on the restriction of the use of certain hazardous substances in electrical and electronic equipment, Official Journal L 037, 13/02/2003:P. 0019 – 0023.
- Regulation (EC) No 1774/2002 of the European Parliament and of the Council of 3 October 2002 laying down health rules concerning animal by-products not intended for human consumption Official Journal L 273, 10/10/2002:P. 0001 – 0095.
- Commission Regulation (EC) No 1877/2006 of 18 December 2006 amending Regulation (EC) No 878/2004 laying down transitional measures in accordance with Regulation (EC) No 1774/2002 for certain animal by-products classified as Category 1 and 2 materials and intended for technical purposes Official Journal L 360, 19/12/2006:P. 0133 – 0136.
- Commission Regulation (EC) No 2007/2006 of 22 December 2006 implementing Regulation (EC) No 1774/2002 of the European Parliament and of the Council as regards the importation and transit of certain intermediate products derived from Category 3 material intended for technical uses in medical devices, in vitro diagnostics and laboratory reagents and amending that Regulation Official Journal L 379 28/12/2006:P. 0098 – 0104.
- Council Directive 88/379/EEC of 7 June 1988 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 187, 16.7.1988, p. 14). Directive as last amended by Commission Directive 96/65/EC (OJ L 265, 18.10.1996, p. 15).
- Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ L 196, 16.8.1967, p. 1). Directive as last amended by Commission Directive 97/69/EC (OJ L 343, 13.12.1997, p. 19).
Websites
- http://ec.europa.eu/enterprise/newapproach/review_en.htm EUROPA website DG Enterprise and Industry, Review of the New Approach.
- http://www.ghtf.org/sg1/sg1-proposed.html Global Harmonisation Task Force (GHTF) work on classification and conformity assessment of IVDMD.
- http://ec.europa.eu/enterprise/medical_devices/meddev/index.htm EUROPA website DG Enterprise Guidelines in relation to medical devices Directive.
- http://www.ghtf.org/sg2/sg2.htm Global Harmonisation Task Force (GHTF) work on vigilance and post market surveillance.
- http://ec.europa.eu/enterprise/newapproach/standardization/harmstds/index_en.html EUROPA DG Enterprise and industry harmonised standards.
- http://ec.europa.eu/enterprise/medical_devices/guide-stds/abhs_n_65_snapshot_may_2007.pdf CEN standards under approval May 2007.
- http://ec.europa.eu/environment/waste/weee/pdf/era_study_final_report.pdf Review of Directive 2002/95/EC (RoHS) categories 8 and 9 September 2006.
- http://ec.europa.eu/food/food/biosafety/animalbyproducts/by_products_report_en.pdf Report on the functioning of Regulation 1774 European Commission 2005.
- http://ec.europa.eu/enterprise/reach/ ghs_en.htm EUROPA Enterprise and industry GHS.adopted proposal.
- http://www.edma-ivd.be/ Website for European Diagnostic Manufacturers Association (EDMA).