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4 May 2012
IBMS has responded to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on Guidance for Notified Bodies on the regulation of IVDs for self-testing.
The MHRA is carrying out a consultation on guidance for notified bodies on the regulation of IVDs for self-testing as part of their Guidance on the EC Medical Devices Directives. The MHRA is an agency responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.
The MHRA consultation sought the views of the IBMS on how notified bodies might best asses the suitability of IVD devices for self-testing.
The IBMS has been able to access expert advice from our Scientific Advisory Panel on the aspects of the consultation pertaining to biomedical science. The experience and expertise of our panel members means that the IBMS is well placed to comment on this consultation.
The MHRA have received the IBMS’ response and will keep you updated on any future developments.