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PPE Application: From Product Inputs to the Required Route
Start an application with a controlled description and evidence plan, not a request to purchase an unexplained CE certificate.
Resolve the input before applying
Record the manufacturer and market, intended protective risks, model/configurations, user range and limitations. Check exclusions, category and applicable essential requirements. Article 19 ordinarily uses A for I, B+C for II, and B with C2 or D for III, subject to its specific exception.
For Module B, the manufacturer applies to one notified body with the required identity, declaration against a duplicate application, Annex III file and representative specimens. Confirm the body's actual tasks and ask for missing-input and specimen requirements rather than submitting inconsistent variants.
Case: a respirator file with only Module B
Hypothetically, an applicant prepares a respirator's type-examination application but plans sale immediately after receiving that document. Establish the actual protective risk and category. Where Category III's ordinary route applies, arrange the C2 or D production stage and its required application before relying on a type certificate as the complete route.
Keep the manufacturer’s declaration, marking, instructions and production evidence consistent with the assessed model. Record genuine findings and revisions, and hold release where required evidence or procedural outputs are missing.
Keep application support bounded
The applicant supplies genuine inputs; laboratories and bodies perform their particular tasks and decide their outputs; the manufacturer owns conformity. A submission receipt or sample delivery is not an approval or proof of compliant serial production.
For Kayra, specify the requested application activity and verify the permitted role and independence before acceptance. The next useful item is a model-specific initial file and responsibility list, without promised acceptance or invented test history.
Questions for this purpose
Is a submission receipt a type certificate?
No. It records submission, not a successful assessment decision.
Can a Category III type certificate replace C2 or D?
The ordinary route also requires the applicable production stage; examine the specific Article 19 exception if relevant.
May the same Module B application be lodged with several bodies?
The application requires a declaration that the same application has not been lodged with another body.
Official sources
- EUR-Lex — PPE Regulation, consolidated text 29 May 2026
- European Commission — PPE scope and resources
- European Commission — PPE harmonised standards references
- European Commission — notified bodies and actual tasks
- EUR-Lex — original PPE Regulation reference
- Your Europe — technical documentation duties
- EUR-Lex — PPE Regulation reference
PPE enquiry: product, risk and requested activity
Share the controlled product description, category basis and missing application inputs for clarification of a permitted activity.