Medical devices encompass some 10 000 types of products, ranging from simple bandages and spectacles, through life-sustaining implantable devices, to the most sophisticated diagnostic imaging and minimally invasive surgical equipment. Around 7 000 European companies, employing about 350 000 people, are active in this sector. The European Parliament, the Council, and especially the companies within the sector, had asked for a revision of the numerous and complex legislative texts which currently apply to medical devices.

The Directive adopted on 29 March 2007 updates some of the existing texts, including a Directive of 20 June 1990 on active implantable medical devices and a Directive of 14 June 1993 concerning the movement, the placing on the market, and the bringing into service of medical devices throughout the internal market. The new legislation will clarify essential elements concerning the safety of medical devices, such as clinical evaluation and conformity assessment. It will also introduce new, positive, provisions such as those aimed at increasing transparency.

Among the major improvements which will be introduced by the new Directive are:

• stricter rules for the use of potentially toxic materials, for which adequate labelling will be required;
• enhancement of the safe single use of devices;
• production of a Commission study examining the issue of reprocessing devices and, if necessary, proposing the adoption of additional legislation; and
• inclusion of specialised medical software within the scope of the new Medical Device Directives.