The new UKCA marking is required after July 1, 2023.
Manufacturers should start acting now to ensure the deadline is met.
When affixing the UKCA marking, the manufacturer takes full responsibility for the product’s conformity with the requirements of the relevant legislation - Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
The cases in which the self-declaration of conformity can be used for UKCA marking are similar to those of the CE marking, such as for Class I devices and IVD general. The information required on the Declaration of Conformity is largely the same as what was required on an EU Declaration of Conformity. The manufacturer will need to list the relevant UK legislation (rather than EU legislation).
For higher risk classes it requires a mandatory third-party conformity assessment and the conformity assessment has been carried out by a UK conformity assessment body.
We recommend to contact your Notified Body as soon as possible and inquiry if they will be able to provide the service as a UK conformity assessment body. At the moment these are the recognized UK approved bodies.
Join our Seminar on the UKCA marking to learn more.