MHRA is delaying the UK MDR 2002 for one year. That means CE marked MedicalDevices (under MDD/IVD/AIMDD/MDR/IVDR) can still be sold in the UK under the CE mark until July 1 2024 – instead of 2023. After that (still not finally confirmed) date the UKCA (under the UK MDR 2002) becomes mandatory.
See the attached WTO announcement from the MHRA (which we received from our well-informed UK partner Ian Sealey).
Important: Non-UK manufacturers require a UK RP (responsible person) to register all medical devices (under both CE/UKCA regulations) already today. See our UK-RP, CE-REP and CH-REP services.
Disclaimer: This announcement states „We will be updating our guidance page shortly to reflect the changes“ – until the guidance page is updated we are not certain about the exact meaning of the extension. The above-stated is our interpretation. Refer to the MHRA webpage for the applicable guidance.
