Module 19: Regulation of In Vitro Diagnostic Medical Devices
28/03/2023
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Brexit & technical documentation
Despite changes to the Northern Ireland Protocol / Windsor Framework, NI will continue to follow EU legislation for medical devices and will accept the CE mark or the CE UKNI mark.
It is widely assumed that in Great Britain the new regulations will be based broadly around the existing IVDR, albeit with some significant changes.
Therefore technical documentation should continue to be based around EU legislation and guidance.
The Organisation for Professionals in Regulatory Affairs
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• … an international recognition framework, allowing the MHRA to capitalise on the expertise and decision making of trusted regulatory partners and provide patients with fast-track access to best-in-class medical products that have been approved in other countries.’ • Using the Agency’s pre-existing international partnerships … the first regulatory partners that the MHRA intends to build new recognition routes with are the FDA, in the USA, and with the PMDA, in Japan. • It has yet to be clarified what type of technical documentation would be required in Great Britain for FDA cleared or approved devices. Brexit & technical documentation https://www.gov.uk/government/news/mhra-to-receive-10m-from-hm-treasury-to-fast-track-patient access-to-cutting-edge-medical-products
The Organisation for Professionals in Regulatory Affairs
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