After Britain leaving the EU, there have been many changes in the regulations regarding medical devices. An example of this is the UK’s Declaration of Conformity.UK Declaration of Conformity (DoC) is a technical document that products with UKCA marking should possess. The information needed on the Declaration of Conformity (DoC) is largely the same as what was required on an EU Declaration of Conformity. According to UK’s guidance on UKCA marking, manufacturers are recommended to keep a separate UK DoC even if their product already has an EU DoC. Moreover, this document should be available to authorities on request.
Contents of UK Declaration of Conformity
The information contained in UK Declaration of conformity resembles that of the EU Declaration of Conformity. See the article on EU Declaration of Conformity. The differences lie in the regulations followed in United Kingdom.
A DoC should have the following details in it.
- Name and Address of the manufacturer or that of the appointed Responsible Person.
- Product’s serial number, part number, model, or type identification.
- Statement declaring full responsibility of the device/product.
- Identification of product allowing traceability (This can include an image).
- Details of the approved body (if applicable).
- Applicable legislation based on which the product complies, along with any designated standards.
- Name of manufacturer and signature.
- Declaration issue date along with the expiry date if mentioned.
- Additional / supplementary information (if applicable)
UKCA marking allows manufacturers to easily market their medical devices within Great Britain (England, Wales, and Scotland). UKCA marking applies to almost all devices that were previously ‘CE marked’.
The UKCA marking is in force from 1 January 2021, but businesses can market CE marked products until 1 January 2023.After which products will also need UKCA marking.