To be eligible for the Challenge Awards, proposals must focus on:
- Products with existing CE certificates (under the MDD/AIMDD/IVDD or MDR/IVDR). The expiry dates of the certificates must at least be valid until the 30 June 2023.
Please note that CE marking will continue to be recognised until 30 June 2023. From 1 July 2023 new devices placed on the Great Britain market will need to conform to the requirements for UKCA (UK Conformity Assessed) marking. UKCA marking will not be recognised in the EU, EEA or Northern Ireland and a CE mark would still be required for sale in these markets.
- Products currently undergoing CE-marking where evidence can be shown that the technical documentation has been submitted for Notified Body assessment, and whereby all of the mandatory testing has been completed.
- All proposals should indicate that the devices involved have been registered with the MHRA, or propose it as a deliverable in the project plan to ensure this is achieved before the end of the grace period permitted for your specific device, which is at the very latest the 31 December 2021. For further information read the government guidance on regulating medical devices in the UK (published on 1 September 2020).
Please note that this is in alignment with the extended government guidance on device registration requirements, whereby from 1 January 2021 (to the 31 December 2021 at the very latest, depending on device type and classification), any medical device, IVD or custom-made device will need to be registered with the MHRA before being placed on the Great Britain market.