The Pharmaceutical Journal
Vol 280 No 7502 p588
17 May 2008

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Regulation of medical devices

Plans to modernise and simplify EU legislation on medical devices have been put forward for public consultation.

The European Commission is suggesting that the current regulatory framework for medical devices could be strengthened by merging the numerous directives pertaining to such products under one legal text.

The EC also raises the idea of extending the competence of the European Medicines Agency to include evaluation of high-risk medical devices, such as coronary stents, pacemakers or HIV test kits, in the interest of public health.