Medical Devices: Conformity Assessment and the UKCA Mark in the UK

1. Introduction to the UKCA Mark The UKCA (UK Conformity Assessed) marking is the product marking system used for goods being placed on the market in Great Britain (England, Scotland, and Wales). For medical devices, it demonstrates that a product complies with the UK Medical Devices Regulations 2002 (UK MDR 2002). Source: Medical devices: conformity assessment and the UKCA mark

2. Recognition of CE Marking and Transition Periods Although the UKCA mark is the long-term requirement, the UK government has introduced transitional arrangements to ensure continued supply and give manufacturers time to adapt.

EU MDD / EU AIMDD compliant devices: Can be placed on the GB market until 30 June 2028 or until the certificate expires, whichever is sooner.

EU MDR / EU IVDR compliant devices: Can be placed on the GB market until 30 June 2030. Source: Regulating medical devices in the UK

3. Conformity Assessment Routes The process to obtain the UKCA mark depends on the classification of the medical device (Class I, IIa, IIb, or III).

Class I (low risk): Manufacturers of non-sterile and non-measuring Class I devices can usually self-declare conformity.

Class IIa, IIb, and III (medium to high risk): Requires a mandatory third-party conformity assessment by a UK Approved Body. Source: Medical devices: conformity assessment and the UKCA mark

4. The Role of UK Approved Bodies A UK Approved Body is an organization designated by the Medicines and Healthcare products Regulatory Agency (MHRA) to conduct conformity assessments for the UK market. They assess whether the manufacturer’s technical documentation and manufacturing processes meet the UK MDR 2002 requirements before a UKCA certificate is issued. Source: Medical devices: conformity assessment and the UKCA mark

5. Northern Ireland Requirements The rules for Northern Ireland differ from Great Britain due to the Northern Ireland Protocol.

Medical devices placed on the Northern Ireland market must continue to bear a CE mark and comply with EU regulations (MDR/IVDR).

If a UK-based Notified Body is used for the assessment, the product must bear both the CE mark and the UKNI mark. Source: Regulating medical devices in the UK

6. Registration and UK Responsible Person (UKRP) All medical devices must be registered with the MHRA before being placed on the GB market. Manufacturers based outside the UK must appoint a UK Responsible Person (UKRP) based in the UK to assume responsibility for the device and act as a point of contact for the regulator. Source: Regulating medical devices in the UK