Technical File for UKCA Mark

A Manufacturer who is willing to place a device on the Great Britain market and its Authorized Representative must maintain technical documentation that demonstrates the conformity of the product with the regulatory requirements. These must be kept for up to 10 years after the product is placed on the market.

The content of the Technical File for UKCA is similar to that of Technical documentation prepared for EU MDR/IVDR with only minor differences in certain aspects.

What are the differences in Technical Documentation of EU MDR and UKCA?

1. The Declaration of Conformity must be signed and a copy of these legal statements should be included in the Technical documentation for the UKCA Mark
2. The UKCA’s Manufacturer Declaration and instructions should be in English.
3. For UKCA until the end of 2021, the Technical Documentation should include copies of third party declarations. Third party declarations can either be UKCA or CE Declarations.
4. Proof of tests or compliance shall be provided in the form of test results for design safety standards. 
5. For the UKCA “UK Designated Standards” should be referred which are the British Standards. Therefore, the Technical Documentation and Declaration of Conformity for the UKCA mark would use the British national BS pre-fix, for example BS EN ISO 13857. 

All the other contents of the Technical Documentation are the same for both the marking systems.
These technical documentation need to be submitted to UK Approved body to demonstrate compliance to UKCA for all classes of device except Manufacturers of Class I medical devices and general IVDs who can self-declare their conformity against the EU MDD or EU IVDD as transposed by the UK MDR 2002 (as amended), before affixing a UKCA mark and placing the device on the Great Britain market. However, Class I medical devices that are sterile or have a measuring function require approval from a UK Approved Body.

UK Declaration of Conformity

In this document, the manufacturer should:

1. Declare that the product conforms to the statutory requirements applicable to the specific product.
2. Name and Address of the manufacturer and/or the authorized representative along with the information about the product and the conformity assessment body. 

The information required on the Declaration of Conformity is nearly the same as required on an EU Declaration of Conformity. This can vary depending on the application legislation but generally should include:

1. Manufacturer’s name and full business address or that of your authorised representative
2. the product’s serial number, model or type identification
3. a statement, stating you take full responsibility for the product’s compliance
4. the details of the approved body which carried out the conformity assessment procedure (if applicable)
5. the relevant legislation with which the product complies
6. your name and signature
7. the date the declaration was issued
8. supplementary information (if applicable)

Additionally, one will need to list:

• relevant UK legislation (rather than EU legislation)
• UK designated standards rather than standards cited in the Official Journal of the European Union

The UK DOC should be available to market surveillance authorities on request.