UK Declaration of Conformity
Navigating UK Medical Device Regulations: Understanding UKCA Marking and Compliance Requirements
The MHRA's current medical device and IVD regulation in the UK is based on the previous Directives, such as the Medical Devices Directive (MDD) 93/42/EEC.
When the MDR came into effect, the UK had already incorporated the MDD into its national law alongside other EU member states. However, following the UK's withdrawal from the EU, the MHRA is now developing its own updated legislation for medical devices and IVDs. This new legislation will solely apply to Great Britain, as Northern Ireland will continue to require CE marking.
In the meantime, since the UK Medical Device Regulation is based on the old Directives, manufacturers can follow the requirements as outlined in the above EU Declaration of Conformity – MDD/AIMDD/IVD section, with the following amendments.
EU Docs amendments for UK Labels:
Replace the referenced legislation with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002) instead of the MDD/AIMDD/IVDD.
Use UKCA marking instead of CE marking.
Refer to the UK Responsible Person instead of a European Authorized Representative.
Identify the UK Approved Body rather than the EU Notified Body.
Regarding harmonized standards, the current UK list still refers to EU standards.
Medical devices placed on the Great Britain market must have a UKCA marking or a CE marking, depending on which legislation the device has been certified under.
Where relevant, the number of the Approved Body or Notified Body must also appear on the label.
Devices can have both the CE and UKCA markings present on the labeling. However, the name and address of the UK Responsible Person, where applicable, needs to be included on product labeling or the outer packaging, or the instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).
Do you have questions regaring the UKCA duedates? Check more information in this blog!