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European Parliament's Internal Market Committee publishes opinion report on device regulation
The opinion report of the European Parliament's Internal Market Committee (IMCO) on proposed changes to cross-border medical device regulations has supported the general principle of EU-level assessment procedures for high-risk devices.
Explaining her support, Lead IMCO Rapporteur Nora Berra MEP (European People’s Party, France) stated, “If we are serious about strengthening the mechanisms governing the placing of medical devices on the market, it is essential that a given type of device should be required to undergo the same assessments, based on the same requirements, anywhere in the Union. This is difficult at present, however, given that there are few if any common assessment methods (guidelines) which manufacturers and notified bodies can employ… Your rapporteur thus endorses the principle of clinical assessment at EU level for high-risk devices which are not covered by common guidelines.”
However, there remains a difference of opinion between the Committee on the Environment, Public Health and Food Safety (ENVI) as to how such centralised assessment might occur. The ENVI committee favours assessment by a special committee of the European Medicines Agency (EMA), while Ms Berra proposes remit be given to a proposed ‘medical device coordination group’ overseen by the European Commission.
As currently constituted, medical device assessment for market is conducted by national bodies, with approval by one body conferring a European-wide ‘CE’ mark, which should be recognised by all member states. This has led to concerns that not all national bodies apply the same rigour in assessment procedures and it is possible for such regulatory gaps to enable unsafe products coming to markets.
The issue of medical device regulation has been a subject of public focus as a result of the high profile Poly Implant Prothèse-breast implant scandal in France and the European Commission published proposals for improving assessment, authorisation and traceability systems in September …
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