Own-brand PPE declarations and instructions
Match the declaration, English instructions and protection claims to the exact PPE model and chosen conformity route. Supply the declaration or information showing where it can be accessed, and check the finished pack before release. Cambridge China Bridge can coordinate factory document collection through its staff in China.
Fix the market, model and route
This guide concerns supply into Great Britain. An own-brand business that has PPE manufactured and markets it under its name or trademark is the manufacturer. Start with our medical devices and PPE guide for classification and certificate checks; here, the task is turning the agreed route into a consistent user pack.
Record the product identifier, intended protection, risk category, chosen marking and supporting assessment evidence in a release checklist. GOV.UK requires the relevant assessment before placement on the market and a UK declaration for UKCA marking or an EU declaration for CE marking. Match the declaration to the route actually completed.
Prepare the declaration against the evidence
The declaration must identify the specific product and give the manufacturer’s name and address, plus the authorised representative’s details where applicable. Treat these as starting fields, not a complete template. Check the full declaration format for your chosen route before signing.
Ask the person preparing the declaration to reconcile the model description, applicable requirements, standards, certificate references, assessment bodies where relevant, and signature details against the underlying file. Flag copied factory names, different model codes and unsupported standards. Use our technical compliance file guide to organise the supporting records.
Write usable instructions and protection limits
PPE must be accompanied by instructions and safety information that are clear, legible and in easily understandable English. Use our supplier instructions guide for the general manual workflow. For this PPE pack, ask a competent reviewer to check that the product-specific information is complete.
Build the review checklist around fitting and adjustment, use, storage, cleaning, maintenance, servicing, disinfection, compatible accessories and replacement parts. Explain symbols and markings. Describe protection using the actual test evidence, including relevant levels or classes, and state excluded uses, conditions that reduce protection and signs that the item should be replaced. Do not invent a service life or turn a limited test result into a general safety claim.
Make the correct declaration accessible
GOV.UK says the declaration must accompany the product, or information showing where it can be accessed must accompany it. For a web-based approach, put the declaration’s web address in the user-information pack. As a practical safeguard, use an address that leads to the correct model’s declaration rather than a general sales page.
Open the printed address from the finished artwork on a device without a company login. Check that the document loads, matches the supplied model and remains readable when downloaded. Keep previous declaration versions identifiable if the product changes, so a later website update does not leave earlier batches pointing to unrelated paperwork.
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Approve the pack with the production sample
Compare a packed production sample with the approved declaration, instructions and artwork. Check model identifiers, claimed protection, accessories, language, leaflet inclusion and the printed web address. Ask the factory for photographs of the actual packed contents and retain the approved files together with the batch record.
Manufacturers must retain the declaration and technical documentation for ten years after the PPE is placed on the Great Britain market. Keep an internal release record showing which document versions accompanied each batch. Ask Cambridge China Bridge’s staff in China to collect factory documents and check packing against your approved pack; assign declaration approval to a named person in your business.
Frequently asked questions
Can I use the factory’s PPE declaration under my brand?
Do not assume it covers your launch. An own-brand business having PPE made and marketing it under its name is the manufacturer. Reconcile the declaration and supporting evidence with your company and exact model.
Do I need a UK or EU declaration for PPE sold in GB?
GOV.UK specifies a UK declaration for UKCA-marked PPE and an EU declaration for CE-marked PPE. Match the document to the marking and conformity route actually used.
Can I provide the PPE declaration through a website?
Yes. GOV.UK allows the declaration to accompany the product or accompanying information showing where it can be accessed. Put the address in the user pack and test that it opens the correct declaration.
What protection limits should PPE instructions explain?
Use the actual test evidence to describe protection. Explain excluded uses, conditions that reduce performance, fitting needs and replacement signs. Ask a competent reviewer to check completeness for the specific PPE.