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ESC Policy Conference makes recommendations for new EU medical device legislation
Date:5/16/2011

74 Notified Bodies (NBs) in Europe dealing with medical devices, many of which are independent commercial organizations. Once the NB has reviewed the technical dossier submitted by the manufacturer and completed its evaluation of the application, it then issues a certificate that permits the manufacturer to affix a CE mark and to market the device throughout the EU. For devices in Class III, the manufacturer must conduct some human clinical investigations, but it is not compulsory that these are randomised clinical trials.

"This process has given rise to suspicions that companies may go "forum shopping" to select the NB that will conduct the least burdensome or the fastest review," write the authors of the paper, adding that no systematic audit of NBs has ever been published.

The paper also cites a number of well publicised failures of cardiovascular devices that may relate to limited evaluation prior to approval. Publication of the consensus document in the EHJ coincides with a series of articles looking at the regulation of medical devices in the British Medical Journal and also a TV Programme in the UK, Dispatches: The Truth About Going Under the Knife on Monday 16 May at 8pm on Channel 4.


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Contact: Jacqueline Partarrieu
press@escardio.org
33-492-947-756
European Society of Cardiology
Source:Eurekalert

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