MHRA Publishes Draft Guidance on Vigilance Systems for Joint Implants.

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This guidance document gives advice to manufacturers on the notification of adverse incidents involving joint replacement implants under the Medical Devices Vigilance System. It is intended to facilitate the uniform application and implementation of Medical Devices Directive 93/42/EEC and Directive 2005/05/EC. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System and the Medicines and Healthcare products Regulatory Agency’s Directives Bulletin 3 ‘Guidance on the operation of the EU vigilance system in the UK’ . This guidance sets out the Medicines and Healthcare products Regulatory Agency’s (MHRA) views on the interpretation of the Medical Devices Regulations . It should not be considered to be an authoritative statement of the law in any particular case as it is intended as guidance only. Manufacturers and others should consult the legislation referred to, making their own decisions on matters affecting them in conjunction with their lawyers and other professional advisers. The MHRA does not accept liability for any errors, omissions, misleading or other statements in the guidance whether negligent or otherwise. An authoritative statement could be given only by the courts.

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