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Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New Statutory Instrument to extend market access for Medical Devices in Great Britain

The UK Parliament have published Statutory Instruments 2023 No. 627 “The Medical Devices (Amendment) (Great Britain) Regulations 2023” to amend the UK Medical Devices Regulations (MDR) 2002 (S.I. 2002/618). The purpose of the amendment is “to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain.” This SI will…
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June 23, 2023
Membership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

UKCA statutory instrument published on implementation timelines

  The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain. BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We…
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May 5, 2023
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