UK Consults on Neurostimulator Vigilance

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued draft guidance to manufacturers on the notification of adverse incidents involving neurostimulators. The guidance aims to “facilitate the uniform application and implementation” of medical devices directive 93/42/EEC, and is supplementary to the European Commission guidelines on the medical devices vigilance system and associated MHRA guidance. The consultation ends September 30 2009.

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