Guidance on the vigilance system for CE-marked Medical Devices

Guidance on the vigilance system for CE-marked medical devices (Joint replacement implants)

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. It is supplementary to, and should be read in conjunction with, the European Commission Guidelines on a Medical Devices Vigilance System.

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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