Commission consults public on medical devices
In the light of recent public concern about breast implants and dialysers, and in a bid to improve public health and safety, the Commission has launched a public consultation on medical devices. Medical devices cover any instrument, appliance or software used for the purpose of disease prevention, screening, diagnosis or treatment, or alleviation of disease. Such a high profile activity requires enhanced safety standards and a coherent EU regulatory framework, together with effective implementation. This is crucial to maintain public confidence. The European Commission is therefore inviting comments on its draft proposal to amend the rules on medical devices (MDD) and on active implantable medical devices (AIMDD). 'The medical device sector is an area where society and citizens directly benefit from innovation and technological progress,' stated Commission Vice-President Günter Verheugen. '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,' he added. The European market for medical device technology, valued at 41 billion euro in 2002, is the world's second largest with 26 per cent of the market share compared to 37 per cent for the US and 15 per cent for Japan. The industry comprises more than 7,000 individual business entities, 70 per cent of which are small and medium-sized enterprises (SMEs). Medical devices are currently regulated under three directives. The Commission has however decided against a merger of the directives on account of technical differences between them. The aim of the amendments is therefore to clarify the regulation to ensure consistency of interpretation and implementation. The consultation is open until 20 June.