You are trained and skilled in the practice of safe clinical procedures. Are you aware however that the safety of the medical devices, which includes medical equipment, that you use routinely in your clinical working day have been designed to be safe for both you and for patients? This is a legal requirement of the Medical Device Regulations by which manufacturers of medical devices and medical equipment are required to design and manufacture their products. That they conform to these regulations is designated by the CE Mark that has to be displayed on the product or on its labelling. This article will outline the legislative requirements of the regulations with which manufacturers have to comply.
European Commission1990Active Implantable Medical Devices Directive 90/385/EECEC Official Journal L189 of 20/7/90
2.
European Commission1993Medical Devices Directive 93/42/EECEC Official Journal L169 12/7/93
3.
European Commission1998In-vitro Diagnostic Medical Devices Directive 98/79/ECEC Official Journal L331 of 07/12/98
4.
European Commission2000EC Directive 2000/70/EC amending Directive 93/42/EEC regarding medical devices incorporating stable derivatives of human blood or plasma and modified by 2001/104/ECEC Official Journal L313 of 16/11/00 and L6 of 10/01/02
5.
European Commission2003a EC Directive 2003/12/EC on the reclassification of breast ImplantsEC Official Journal L28 of 04/02/03
6.
European Commission2003b EC Directive 2003/32/EC regarding medical devices utilizing tissues of animal originEC Official Journal L105 of 26/04/03
7.
European Commission2005EC Directive 2005/50/EC Reclassification of hip knee and shoulder joint replacementsEC Official Journal L 210 of 12/08/05
8.
European Commission2007EC Directive 2007/47/EC revision to the Active Implantable Medical Devices Directive and the Medical Devices DirectiveEC Official Journal L247 of 21/09/07
