June 19, 2023
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has updated guidance delaying the future implementation of medical device legislation. In addition, a Statutory Instrument has now been published, as proposed in Jan 2023, to ensure that compliance with the EU medical device legislation supports the ongoing safe supply of medical devices by continuing to grant access to the UK market.
Since the reforms were initially announced in 2021, there have been some delays. The most newsworthy is that the UK now intends for their future regime to apply starting July 1, 2025 – a further delay of one year from the currently proposed dates (announced in Oct 2022) of the summer of 2024. There is also a slight delay in the Statutory Instrument for Post-Market Surveillance (PMS).
Revised MHRA guidance
Included with the newly revised MHRA guidance are infographics which present the deadlines for both medical devices and IVDs.
On June 14 the UK government released Statutory Instrument 2023 No. 627 “Medical Devices (Amendment) (Great Britain) Regulations 2023” to amend the UK Medical Devices Regulations (MDR) 2002, which will come into force on June 30 (Regulations 1 to 4) and July 1 (Regulations 5 to 10). The amendment was the commitment to revise the “standstill date” of June 30, 2023. The explanatory note further states 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.” The dates for continued compliance are until June 30, 2030, depending on device classification and applicable legislation.
Deadlines for medical devices with CE Marking
Manufacturers can leverage an EU Medical Devices Directive (MDD) 93/42/EEC CE marking certificate from a Notified Body or compliance to the MDD to the following dates:
- For Class III or Class IIb implantable device until December 31, 2027.
- For Class IIb, Class IIa, Class I sterile and Class I measuring device until June 30, 2028.
- For MDD Class I self-certified, upclassified by the MDR, until June 30, 2028.
Manufacturers of all devices can leverage compliance to the MDR until June 30, 2030.
Deadlines for IVD devices
Manufacturers can leverage an EU notified body In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC CE marking certificate or compliance to the IVDD to the following dates:
- For Annex II, List A, Annex II, List B, and self-testing until May 26, 2025.
- For IVDD self-certified, upclassified by the IVDR, until June 30, 2030.
Manufacturers of all IVDs can leverage compliance to the IVDR until June 30, 2030.
The UK government is still committed to strengthening PMS. Legislation on PMS was previously expected in the summer 2023 with implementation of winter 2023/early 2024, though now it is expected “later in 2023” with expected applicability in mid-2024.
The infographic visually provides great data on the timelines for when EU compliance will be accepted in the UK.
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