Published 21st June 2023
The UK Parliament has recently published SI 2023 No. 627, known as The Medical Devices (Amendment) (Great Britain) Regulations 2023.
This amendment brings changes to the existing Medical Devices Regulations 2002 (S.I. 2002/618) in the UK. The primary purpose of this amendment is to extend the period during which medical devices with a CE mark can be placed on the market in Great Britain (GB).
The extension of these periods is a response to the European Union’s decision to prolong the validity of certain certificates related to the Medical Devices Directive (MDD 93/42/EEC) and Active Implantable Medical Devices Directive (AIMDD 90/385/EEC). In addition, the amendment also allows a manufacturer to leverage CE certificates under the Medical Devices Regulation, EU 2017/745 (MDR) and the In Vitro Medical Devices Regulation, EU 2017/746 (IVDR). This extension ensures the uninterrupted supply of medical devices in the EU market, which in turn guarantees continued access to these devices in GB and aids in the transition to the future regulatory framework.
Under the new amendment, medical devices with a valid CE certificate can now be placed on the GB market based on the following timelines:
This amendment provides benefits to manufacturers of medical devices with a valid CE mark under EU legislation who intend to distribute their devices in the GB market. It offers additional time for transitioning to the GB framework. The acceptability of EU MDD and AIMDD certificates is contingent upon their extension as outlined in Regulation (EU) 2023/607, dated 15 March 2023. Extension of these certificates is subject to specific conditions, such as compliance with MDR requirements related to Vigilance, Post-Market Surveillance, and Registration for Economic Operators. The devices should continue to adhere to MDD/AIMDD requirements, maintain the same design and intended purpose without presenting any unacceptable risks to user/patient health and safety.
Manufacturers are also expected to have a MDR-compliant Quality Management System (QMS) in place by 26 May 2024 and submit a formal MDR conformity assessment application to a Notified Body before the same date. Additionally, a written agreement between the manufacturer and the Notified Body regarding the conformity assessment must be in place before 26 May 2024. You can read more about Regulation (EU) 2023/607 here.
Manufacturers utilising this amendment to place devices on the GB market must ensure compliance with GB post-market surveillance and vigilance requirements in addition to possessing a valid CE certificate.
While this amendment is a positive development, manufacturers should be mindful of the strict requirements associated with extending MDD and AIMDD certificates. Notably, it is reassuring to see that the Medicines and Healthcare products Regulatory Agency (MHRA) will accept EU MDR and IVDR certified medical devices until 2030.
By staying informed about the requirements and conditions associated with extending MDD and AIMDD certificates, you can make the most of this positive development.