Entering the UK Market: UKCA

UKCA is the conformity mark for the Great Britain market (England, Wales, Scotland). The technical requirements come largely from the same root as EU legislation; the difference lies in the body carrying out the assessment and in the legal basis of the declaration.

The obligation lies with the manufacturer; for manufacturers outside the United Kingdom the importer placing the product on the market is the responsible party and puts its name on the product.

• The UK regulations and designated standards applied
• Test reports
• The technical file (accessible in the United Kingdom)
• The UK Declaration of Conformity
• A UK Approved Body certificate (where required)
• An English-language user manual

1. 01Scope DeterminationIt is determined which legislation and marking scope the product falls under in the target market. This step defines the entire process; getting it wrong wastes all subsequent work.
2. 02Determining Applicable StandardsThe standards accepted by the market and any national deviations are identified. The same IEC standard may apply with different deviations in different markets.
3. 03Establishing the Test PlanIt is assessed which part of existing test reports will be accepted; missing tests are planned. A CB Scheme report, if available, reduces retesting.
4. 04Local Party and RegistrationIf the market requires an established representative, importer or applicant, this party is designated and the necessary registrations are made.
5. 05Tests and Technical FileTests are conducted and the technical file is prepared. Some markets require testing to be performed within their own country.
6. 06Certification or DeclarationDepending on the market's regime, a manufacturer's declaration is drawn up or a certificate is obtained from the authorised body; a factory audit is carried out if required.
7. 07Marking and LabellingThe mark and label are applied according to the market's format and language rules. The language requirement is checked at customs in most markets.
8. 08Shipment and CustomsIf a pre-shipment document is required, it is obtained; the document set to be presented at customs is completed.

• An EU notified body certificate is not directly valid for UKCA
• Northern Ireland is subject to a separate regime
• CE acceptance continues for many product groups; confirmation is needed by product group
• The technical file is expected to be accessible within the UK

1. 01UKCA and CEThe essential requirements are largely the same; the distinction lies in the legal framework, the mark and the identity of the body. Test reports are reusable and the declaration is renewed.
2. 02Great Britain and Northern IrelandThe sets of obligations for the two regions can diverge; assuming that a single mark covers sales to both is incorrect and marking is established by region.
3. 03An EU notified body and a body designated in the countryUnder legislation requiring a body, the EU body's certificate is not valid; the file is resubmitted to a body designated in the country.
4. 04UKCA and UK MDRMedical devices are subject to their own national arrangement and depart from the logic of the general conformity mark; a responsible person established in the country and registration are required.

This page describes entry into the United Kingdom market. The scheme itself — its scope, process, validity period and required documents — is covered in detail on the certification page.

This section's content is being prepared. The roadmap specific to your product and target market at the quote stage in writing.