UK: Official Update of Medical Devices (Amendment) (Great Britain) Regulations 2023

ARQon
Jun 22, 2023
2 min read

In the previous blog, the Medicines and Healthcare products Regulatory Agency (MHRA) proposed for timeline extension for CE-marked medical devices in the hope to smoothen the transition to the new regulatory framework. The Medical Devices (Amendment) (Great Britain) Regulations 2023 were later formally adopted and enforced on July 1, 2023.

The timeline extension involves general medical devices, in vitro diagnostic medical devices, and custom-made devices that comply with the EU MDR can continue to be placed in Great Britain’s market as per the proposed legislation.

Class I and IVD medical devices can generally be placed on the market only if the EU MDR or IVDR requires Notified Body intervention. Custom-made medical devices compliant with EU MDD or EU AIMDD are not allowed to be placed on the market. Addition into the legislation, Class I medical devices with aseptic or measurement functions are allowed to be on the market until 30 June 2028 with a valid MDD certificate.

Besides, the amended regulations also allow self-declared CE-marked Class I medical devices to be on the market until 30 June 2030 with conditions:

The medical devices are self-declared against EU MDR requirements until 30 June 2030, or
The medical devices are self-declared against MDD requirements before 26 May 2021 with the involvement of a notified body (not required by MDD), if require under EU MDR, the extension will be valid until 30 June 2028.

The extension timeline of the CE-marked medical devices placement can be found in the infographic provided here. The government also will enforce post-market surveillance in order to ensure the regulatory transition able to improvise the patients’ safety.

Source: Medicines & Healthcare products Regulatory Agency