Gapfile

Product categories / Bicycle helmets

GPSR technical documentation for bicycle helmets — template and requirements

Bicycle helmets are category II personal protective equipment. That means EU type-examination by a notified body, a certificate valid for at most five years and testing to EN 1078 — on top of instructions, an EU declaration of conformity and marking.

Which rules apply?

The PPE Regulation (category II) governs the safety requirements, EU type-examination, technical documentation and CE marking. The GPSR covers what the regulation does not — above all the rules for online sales (Art. 19) and accident reporting (Art. 20).

LegislationRole
(EU) 2016/425
PPE Regulation (personal protective equipment)
Primary legislation
(EU) 2019/1020
Market Surveillance Regulation
Art. 4: economic operator in the EU
(EU) 2023/988
General Product Safety Regulation (GPSR)
Art. 19–20: online sales and accidents

Standards

  • EN 1078:2012+A1:2012 — Helmets for pedal cyclists and for users of skateboards and roller skates
    Harmonised under (EU) 2016/425 by Implementing Decision (EU) 2023/941. EN 1080:2013 covers helmets for young children.

Template: what the technical file must contain

This structure is the same as in the technical file generated by the tool. Requirements that only apply to some products show their condition.

Product details and economic operators

  • Economic operator in the EUCritical

    The product may not be placed on the market unless an economic operator established in the EU is responsible for it. Name and contact details must appear on the product, its packaging, the parcel or an accompanying document.

    GPSR Art. 16(1) / Reg. (EU) 2019/1020 Art. 4 · Information · Applies if “Is the manufacturer established outside the EU?” Yes

  • Description of the helmet and its intended useCritical

    The technical documentation must contain a complete description of the PPE and its intended use.

    (EU) 2016/425 Annex III(a) · Information

  • Manufacturer name and postal addressCritical

    The manufacturer's name, registered trade name or trade mark and postal address must be indicated on the helmet or, where that is not possible, on the packaging or in an accompanying document.

    (EU) 2016/425 Art. 8(6) · Information

Risk analysis and assessments

  • Risk assessmentCritical

    The technical documentation must contain an assessment of the risks against which the helmet is designed to protect.

    (EU) 2016/425 Annex III(b) · Document

Test reports and certificates

  • EU type-examination certificate from a notified body (Module B)Critical

    Category II requires EU type-examination by a notified body followed by conformity to type. A newly issued or renewed certificate is valid for at most five years.

    (EU) 2016/425 Art. 19(b), Annex V point 6.1 · Test report / certificate

  • EN 1078 test reportCritical

    Shows shock absorption, strength and effectiveness of the retention system, and field of vision. EN 1078:2012+A1:2012 is harmonised under the PPE Regulation.

    (EU) 2016/425 Art. 14; Implementing Decision (EU) 2023/941 · Test report / certificate

Declarations, instructions and procedures

  • Product listing with mandatory informationMajor

    The listing must clearly show: the manufacturer's name, postal and email address; the responsible person in the EU if the manufacturer is outside the EU; a picture and identification of the product (type and other identifier); and warnings and safety information in a language consumers easily understand.

    GPSR Art. 19 · Document · Applies if “Is the product sold through a webshop or marketplace (e.g. Amazon)?” Yes

  • Accident reporting procedureMinor

    The manufacturer must ensure that accidents caused by the product are notified without undue delay to the competent authority via the Safety Business Gateway.

    GPSR Art. 20 · Document

  • Conformity to type — internal production control (Module C)Major

    Documentation showing that manufacturing ensures the helmets conform to the type-examined model.

    (EU) 2016/425 Art. 19(b), Annex VI · Document

  • Instructions according to Annex II point 1.4Critical

    The helmet must be accompanied by the instructions and information in Annex II point 1.4, including manufacturer name and address, storage, cleaning, lifetime, level of protection, notified body name and number, and the web address of the EU declaration of conformity.

    (EU) 2016/425 Art. 8(7), Annex II point 1.4 · Document

  • EU declaration of conformityCritical

    Signed declaration following the structure in Annex IX. Must accompany the helmet or be available at a web address given in the instructions.

    (EU) 2016/425 Art. 15, Annex IX · Document

Marking and warnings

  • CE markingCritical

    The CE marking must be affixed visibly, legibly and indelibly. For category II no notified body number follows the CE marking.

    (EU) 2016/425 Art. 17 · Marking

  • Product identification (type, batch or serial number)Major

    The helmet must bear a type, batch or serial number or other element allowing its identification.

    (EU) 2016/425 Art. 8(5) · Marking

  • Marking according to EN 1078Major

    The helmet must be marked with, among others, the number of the standard, manufacturer, model, size or size range, weight and year and quarter of manufacture.

    EN 1078:2012+A1:2012 (marking) · Marking

Start the gap analysis for your product

Answer 2 questions — you'll see straight away which of the 14 requirements apply and what is missing.

Is the manufacturer established outside the EU?
If yes, an economic operator in the EU is required (importer, authorised representative or fulfilment service provider).
Is the product sold through a webshop or marketplace (e.g. Amazon)?
GPSR Art. 19 sets out what the product listing must show.
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Reviewed by an expert. Rule set version 2, last reviewed 2026-10-10. This page helps you find gaps and does not replace an assessment by an expert or test laboratory.