UK: Timeline Extension of CE-Marked Medical Devices for the UK Market

ARQon
Jun 16, 2023
1 min read

The permitted of CE-marked medical devices in the UK under the regulations of Medical Device Regulations 2022 (UK MDR) will end on 30 June 2023. The UK government is outlining the reformation of the regulatory framework in order to prevent disruption of medical device supply and maximize the system utilization to support the healthcare system.

Hence, the Medicines & Healthcare products Regulatory Agency (MHRA) proposed the timeline extension and planning to lay out the legislation before 30 June 2023. Together with approval from Parliament, this effort may help to smoothen the transition process and ensure the safety of medical supplies to the market. Below is the proposed new timeline for CE-marked medical devices that are permissible to be in the UK market.

30 June 2028 or the certification expiry date: Applicable for any valid declaration with CE marking general medical devices that comply with EU MDD or EU AIMDD
30 June 2030 or the certification expiry date: Applicable for any IVDs medical devices that comply with EU IVDD
30 June 2030: Applicable for general medical devices, custom-made devices that comply with EU MDR, or, IVDs medical devices that comply with EU IVDR

However, custom-made medical devices that comply with EU MDD or EU AIMDD will not be permissible in the UK market after 30 June 2023. This regulation also applies to Class I medical devices that are authorized under EU MDR or EU IVDR with the presence of notified bodies only.

Source: MHRA