For a time-limited period, UK would continue to recognise the CE Mark on medical devices.
” The UK will comply with all key elements of the Medical Devices Regulation (MDR) and the in vitro diagnostic Regulations (IVDR), which will apply in the EU from May 2020 and 2022 respectively.
“UK-based Notified Bodies would, in a ‘no-deal’ scenario, no longer be able to assess the conformity of medical devices for devices to receive the CE mark and enter the EU market.”
“..MHRA would continue to perform national post-market surveillance of medical devices on the UK market, and able to take a national decision over the marketing of a device in the UK, regardless of the position of the European regulatory network, or any decision of the CJEU.”
Notice of 6 August: CE marking during implementation period as part of Withdrawal Agreement (until December 2020)
“CE marking will continue to be used and recognised for both the UK and EU markets, and UK-based manufacturers will not require an authorised representative established in the EU.”
“UK notified bodies will continue to conduct third-party conformity assessment in the UK and the results of these tests will continue to be used and recognised for both the UK and EU markets.”
The document also states that the MDR will be fully applied in the UK between May and December 2020. We will keep you informed when the planned UK MDR Guidance documents are published.