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UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument for the Windsor Framework published

The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…
admin
March 24, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA request to engage earlier for safety issues

MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…
admin
March 17, 2023