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Brussels, 20 May 2005

Medical devices: Commission consults public to improve public health and safety

Medical devices comprise any instrument, appliance, software, etc. used for the purpose of disease prevention (e.g. vaccine-delivery devices), screening (e.g. mammography for breast cancer), diagnosis (e.g. use ultrasound system) or treatment or alleviation of disease. Recent public concern about breast implants, dialysers etc. shows that the medical devices sector represents a high profile activity and that the public expects enhanced safety standards. Consequently, a coherent EU regulatory framework and an effective implementation is crucial to maintain the highest level of public confidence. The European Commission has now invited the public to comment on its draft proposal to amend the rules on medical devices (MDD)[1] and on active implantable medical devices (AIMDD)[2] . The Commission is considering to relax confidentiality to allow certain information on all devices to be publicly available, thus improving transparency.

Commission Vice-President Günter Verheugen stated: “The medical device sector is an area where society and citizens directly benefit from innovation and technological progress. Our proposal aims to improve coherence, transparency and effectiveness of the relevant legislation. We invite all interested parties to suggest possible improvements to the draft proposal.”

In the report on the functioning of the Directives on Medical Devices of 2002, the Commission’s Medical Device Experts Group (MDEG) concluded that whilst the Medical Devices Directives (see below) provide an appropriate legal framework, there was room for improvement in implementation of the directives by all interested parties, including industry.

For example, the proposed amendments are intended to improve:

  • clinical evaluation, through clarification of the requirements,
  • post market surveillance, to increase transparency for the general public,
  • consistency between the medical devices and the active implantable medical devices directives,
  • the decision-making process, by allowing binding decisions in case of conflicting national interpretations on whether or not a product is a medical device.

Medical devices are currently regulated under three main Directives covering respectively active implantable medical devices (AIMD), medical devices (MDD) and in vitro diagnostic medical devices (IVDD). Due to technical differences between the three directives, the Commission has decided against a merger of the directives. At the moment, better regulation will therefore be achieved through regulatory clarifications to ensure consistency of interpretation and implementation.

The European market for medical device technology is the world’s second largest (US: 37%, EU-15: 26%, Japan: 15%) and was valued at € 41 billion in 2002. The industry comprises more than 7,000 individual business entities, 70% of which are SMEs and employs more than 300,000 people. In recent years, the sector has suffered losses in world market share and employment, mainly due to market consolidation and significantly lower European expenditure on healthcare (5.7% of GDP in EU-15 compared to 13.9% in the US and 7.1% in Japan).

Comments should be submitted via e-mail. The period for consultation will remain open until 25th of June 2005.

The on-line consultation:

[1] Directive 93/42/EEC

[2] Directive 90/385/EEC

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