On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023 No. 627 amends the Medical Device Regulation 2002 to extend the period to place certain medical devices on the Great Britain market. Consequently, in line with the EU’s transitional period extension for legacy devices, the UK Government recognises the extension granted for CE marking.
This UK Statutory Instrument is coming into force on 30 June, for Regulations 1 to 4, and on July 1 for the rest (Regulations 5 to 10).
MHRA timeline for placing devices on the GB market
Today, the Medicines and Healthcare products Regulatory Agency (MHRA) also issued an infograph clarifying the deadlines for placing CE marked IVDs and medical devices on the Great Britain market. The timeline depends on the class of the device under the Directive/Regulation. Class I devices that are EU MDR compliant or Class A devices that are EU IVDR compliant can be marketed on the GB market until 30 June 2030. Class IIb devices can rely on the extended CE MDD Certificate in the UK until 30 June 2028 (if conditions for extension apply in the EU) and until 30 June 2030, if covered by a valid CE MDR Certificate. While, Class III devices can be marketed on the GB market until 31 December 2027 with their MDD CE Certificate (if conditions for extension apply in the EU) or until 30 June 2030, if covered by a valid MDR CE Certificate.
Image 1&2: Timelines for placing CE marked devices on the GB market
Source of images: MHRA, GOV.UK
You can find all relevant documents in the UK & Switzerland MDR and IVDR sections!
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