The Medical Devices (Amendment) (Great Britain) Regulations 2023
Overview
In an effort to safeguard the health of patients and ensure a seamless transition to the post-EU exit UK Conformity Assessed (UKCA) marking regime for medical devices, the Medicines and Healthcare products Regulatory Agency (MHRA) has introduced the Medical Devices (Amendment) (Great Britain) Regulations 2023. These regulations provide additional time for the UK medical devices sector to adapt to the new marking regime, thereby ensuring the availability of safe and high-quality medical devices in Great Britain (GB).
The primary objective of the Medical Devices (Amendment) (Great Britain) Regulations 2023 is to extend the period during which manufacturers and importers can place CE marked medical devices on the GB market. By allowing the continued acceptance of CE marked devices, these regulations aim to ensure the continuity of supply and availability of medical devices, minimizing any potential disruptions that may arise during the transition period.
Furthermore, the regulations amend the existing UK Medical Devices Regulations 2002, which were made under the European Communities Act 1972. They incorporate changes necessary to address the deficiencies arising from the UK’s exit from the European Union and the repeal of Directives 90/385/EEC, 93/42/EEC, and 98/79/EC. These amendments provide clarity on the validity of certificates issued under EU legislation and establish transition periods for the acceptance of CE marked devices.
Since January 1, 2021, manufacturers have had the option to use either the UKCA route or comply with EU legislation to place medical devices on the GB market. The Medical Devices (Amendment) (Great Britain) Regulations 2023 extend the acceptance of CE marked devices until June 30, 2030, allowing the UK medical devices sector sufficient time to prepare for the future UK regulatory regime. This ensures a smooth transition and minimizes any disruption to the availability of medical devices in the market.
The Medical Devices (Amendment) (Great Britain) Regulations 2023 were made on the 9th of June 2023 and came into force on the 1st of July 2023.
The Medical Devices (Amendment) (Great Britain) Regulations 2023 fall under the jurisdiction of national authorities in the following countries:
- Great Britain;
- England;
- Scotland; and
- Wales.
Do the Medical Devices (Amendment) (Great Britain) Regulations 2023 affect my business?
The Medical Devices (Amendment) (Great Britain) Regulations 2023 play a crucial role in ensuring the continuity of supply and availability of medical devices in Great Britain. By extending the acceptance of CE marked devices and providing transitional periods, these regulations enable the UK medical devices sector to adapt to the post-EU exit UKCA marking regime. Patient safety remains a priority, and these regulations contribute to maintaining the high standards of quality and safety in medical devices. Through diligent implementation and continued collaboration between regulatory authorities, manufacturers, and healthcare professionals, the UK medical devices sector is well-equipped for a seamless transition to the new regulatory landscape.
Do I need the Medical Devices (Amendment) (Great Britain) Regulations 2023 in my ISO Compliance Register?
You will need the Medical Devices (Amendment) (Great Britain) Regulations 2023 in your ISO Compliance Register if you are:
- Manufacturing;
- Marketing; or
- Supplying,
Medicines or Medical Devices, including Human Medicines, Veterinary Medicines, Medical Devices.
Legislation related to the Medical Devices (Amendment) (Great Britain) Regulations 2023
Legislation related to the Medical Devices (Amendment) (Great Britain) Regulations 2023 include:
- Medicines and Medical Devices Act 2021
- The Medical Devices Regulations 2002
- Regulation 2017/745/EU on medical devices
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices
More information
Visit the Medical Devices (Amendment) (Great Britain) Regulations 2023 article on the legislation.gov.uk website.
Create an account in the ISO Compliance Register App and add this article (in which you will find the Medical Devices (Amendment) (Great Britain) Regulations 2023) to your Register.
