UK has recently published their amendments to the UK Medical Device Regulations.
CE marked devices compliant with MDR/IVDR will be accepted on the GB market until June 30th 2030.
The Medical Devices (Amendment) (Great Britain) Regulations 2023
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| The Medical Devices (Amendment) (Great Britain) Regulations 2023 |
| These Regulations amend the Medical Devices Regulations 2002 (S.I. 2002/618) ("the 2002 Regulations") to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain. The 2002 Regulations were made under section 2(2) of the European Communities Act 1972 (c. |
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Abi Bamigbade
Head of Quality and Regulatory Affairs
Kays Medical Ltd, UK.
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