On April 27th, 2023, the UK Government published a draft amendment to the UK Medical Device Regulations 2002 which is the first statutory instrument released in the process towards a new regulatory framework. This future regulatory framework will introduce a substantial reform of the current legislation for medical devices (The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) in the UK. This statutory instrument addresses the transitional provisions and reflects an intended extension to acceptance of CE marked medical devices on the Great Britain market beyond 30 June 2023, the end date initially incorporated into the UK MDR 2002 (as amended).
2023 No. MEDICAL DEVICES The Medical Devices (Amendment) (Great Britain) Regulations 2023
Currently, in accordance with the UK MDR 2002 (as amended) validly CE marked medical devices and IVDs can be placed on the Great Britain market until 30 June 2023. A valid CE marking is a CE marking that enables the medical device to be placed on the EU market. However, subject to Parliamentary approval, the UK Government intends to introduce measures before 30 June 2023 which will allow CE marked medical devices and IVDs an extended access to the Great Britain market as per the following timelines:
- General medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (AIMDD) with a valid declaration of conformity and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028.
- In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (IVDD) can continue to utilise their CE certificate or declaration of conformity to place devices on the GB market until 2030, as long as the CE certificate or declaration of conformity was dated prior to new date of application, or until expiry of the certificate.
- General medical devices including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
While the draft statutory instrument removes the current date of application of UKCA marking (1 July 2023) from the UK MDR 2002 (as amended) it does not indicate a replacement date. For this new date we refer to the MHRA document that was issued at the same time as the draft statutory instrument, “Standard Implementation of the Future Regulations” which indicates as possible date of application 1 July 2025.
Comparison
Transition to new UK Legislation for UKCA marking | Prior understanding | New understanding |
Date of application (DoA) | 01 July 2023 (In October 2022 MHRA extended the standstill period until 01 July 2024) | Unknown Date of Application has been removed in the draft statutory instrument, however documents from MHRA mention 01 July 2025* |
Transition for CE IVDD products | 5 years from the Date of Application of the new legislation if CE Certificate or Declaration of Conformity (DoC) was dated before new Date of Application (01 July 2024) or until expiry of certificate, whichever comes first | Can continue to utilise CE certificate or DoC to place on the Great Britain (GB) market until 30 June 2030 as long as Certificate is dated before the Date of Application of the new legislation (Date To be confirmed*) or until expiry of certificate, whichever comes first. |
Transition for CE IVDR products | 5 years from the Date of Application of the new legislation. Date of CE certification or DoC does not have an impact on eligibility of transition window (as long as the certificate or declaration is valid in EU) | 30 June 2030 Date of CE certification or DoC does not have an impact on eligibility of transition window (as long as the certificate or declaration is valid in EU) |
Transition for CE MDD or AIMDD | 3 years from the Date of Application of the new legislation if CE DoC was dated before new Date of Application (01 July 2024) or until expiry of certificate, whichever comes first | Can continue to utilise CE certificate or DoC to place on the Great Britain (GB) market until 30 June 2028 as long as certificate or DoC is dated before Date of Application of the new legislation (Date To be confirmed*) or until expiry of certificate, whichever comes first. |
Some important considerations:
- For self-certified CE IVDD products that remain self-certified under IVDR (class A) the transition timelines do not apply: UKCA regulation applies from the Date of Application of the new legislation (Date To be confirmed*)
- The transitional regime for CE (IVDD/ IVDR) is dependent on EU documentation being valid: Eg. For a “general” IVD under the IVDD which up-classifies to Class D the IVDD DoC ultimately expires 26 May 2025. A new UKCA certificate will thus be needed from 27 May 2025 to place the IVD on the GB market.
The government also intends to introduce legislation later in 2023 that will bring into force strengthened post-market surveillance requirements ahead of the wider future regulatory regime. This reflects the government’s priority of improving patient safety as part of the future medical device regulations. These post-market surveillance requirements are expected to apply from mid-2024. Currently, we have been informed that it is the UK governments intent to release a first draft of the future legislation by the end of 2023.
It is expected that this draft law will be approved in the coming month, we will keep you informed if anything changes.
What does this mean to you?
This draft UK statutory instrument is of importance for all device manufacturers that want to bring medical devices and IVDs to the Great Britain market as it can impact your product release strategy.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.
