MHRA consultation on proposed changes to the EU medical device directives (UK)

Something other than wine for device suppliers to be mulling over the Christmas holiday season: the MHRA’s consultation about proposed changes to the European medical device directives closes on 21 January 2013. The MHRA “has been engaging with the Commission to influence its proposals as they have been developed over the last four years. We are pleased to see that they include measures that will improve the transparency, traceability, vigilance, and governance of the system, as well as the performance of notified bodies. However there are also areas of concern in the proposed regulations, notably those provisions which place additional burdens on industry and healthcare systems without a credible evidence base of the public health benefit.” For more information start here, then go here.

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