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 come into force on June 30 (Regulations 1 to 4) and July 1 (Regulations 5 to 10).
More information on SI 2023 No. 627 can be found here, including detailed guidance on the timelines for existing CE marked medical devices.
If you have any questions, please contact regulatory@bivda.org.uk.
