UKCA mark or CE mark?
UK CA mark
If your device is a UKCA (UK Conformity Assessed) labelled product, the details of your UK representative (UKRP) must be registered immediately after appointment.
CE Mark
In case your device is CE marked and is entitled to the extended UK marketing arrangements (see below), the UKRP details need not be added to the device labels till then. The MHRA will accept a CE certificate issued under European Regulation (EU) 2017/745. If your medical device product has a CE mark issued by the EU Notified Body accredited under the EU MDR regulations, it can be placed in the Northern Ireland market.
Future Acceptance of CE Marking
The revised timeframes in which CE Marked devices may be marketed in Great Britain are:
| Device class | Final acceptance date | Exception |
| MDD/AIMDD CE Marked legacy devices | 30 June 2028 | Unless The device no longer qualifies as a legacy device under MDR Article 120 |
| IVDD CE Marked legacy devices | 30 June 2030 | Unless the device no longer qualifies as a legacy device under IVDR Article 110 |
| MDR/IVDR CE Marked devices | 30 June 2030 | Unless the CE Certificate expires |