Can I comply with GPSR without following a harmonised European standard?

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Jason van de Zande

You can comply with the General Product Safety Regulation (EU) 2023/988 (GPSR) without following a harmonised European standard, as long as you can demonstrate that the product is safe under reasonably foreseeable conditions of use. Harmonised standards are a common, efficient route because they can provide a presumption of conformity, but they are not the only route. The key is to build a defensible evidence package and be ready to provide it to authorities on request.

Can you comply with the GPSR without using a harmonised European standard?

Yes. Under EU product rules, harmonised European standards are generally voluntary, and GPSR compliance can be demonstrated through other appropriate technical solutions and evidence. Using a harmonised standard whose reference is published in the Official Journal of the EU can provide a presumption of conformity, but you can also demonstrate safety through alternative standards, test methods, and risk controls.

Two practical cautions matter. First, the presumption of conformity does not prevent authorities from acting if they have evidence that a product is dangerous. Second, some products are also subject to sector-specific EU harmonisation legislation (for example, certain electrical equipment), where standards are a common way to show compliance, but they are still not automatically mandatory in every case. The GPSR also acts as a safety net: it applies fully when no specific EU safety rules cover the same risks, and it applies to uncovered risks when other legislation exists.

What evidence do you need if you do not follow a harmonised standard?

You need evidence showing that your product is safe and that you manage safety throughout the product lifecycle. Without a harmonised standard, authorities will expect a clear, structured justification supported by documented risk assessment and test evidence, plus traceability and user information that matches the product and its intended use.

  • Product risk assessment covering hazards, foreseeable misuse, vulnerable users, and risk-reduction measures.
  • Design and manufacturing controls, including specifications, critical components, and quality checks.
  • Test reports to alternative standards or methods (for example, ISO, IEC, EN, ASTM, UL), with pass criteria tied to identified risks.
  • Accident and complaint monitoring, including how you evaluate safety signals and decide on corrective actions.
  • Traceability information, such as product identification, manufacturer details, and batch or serial controls where relevant.
  • Instructions and warnings in the languages required for the Member States where the product is made available.
  • Technical documentation that is complete, consistent with the product listing and labels, and ready to be provided to market surveillance authorities on request.

Also keep in mind that the GPSR requires a precautionary approach: if there is reason to doubt a safety impact, you should take preventive measures rather than waiting for harm to occur.

How do you choose alternative standards or test methods for GPSR compliance?

Choose alternatives by starting with the risks your product presents, then selecting standards and tests that address those risks at an equivalent or higher safety level. The goal is not to collect certificates; it is to create a reasoned, documented safety case that a market surveillance authority can follow and verify.

  1. Check whether sector-specific EU harmonisation legislation applies, and identify which risks it covers versus what the GPSR still covers.
  2. Identify relevant standards and guidance, including EN, ISO, IEC, and, where appropriate, national or industry standards such as ASTM or UL.
  3. Map each key hazard to a requirement and a verification method, then define a test plan with acceptance criteria.
  4. Use competent, preferably accredited, laboratories when third-party testing strengthens credibility or when methods are complex.
  5. Document equivalence, deviations, and engineering rationale, especially when you adapt a method or combine multiple standards.
  6. Maintain change control so that design changes, supplier changes, and software updates trigger a review of the risk assessment and evidence.

How does EARP help with GPSR compliance without harmonised standards?

We help you build a GPSR-ready evidence package even when harmonised standards are not the best fit for your product, or when no relevant harmonised standard exists. Our work stays focused on compliance, documentation readiness, and smooth communication with authorities.

  • Gap assessment against GPSR obligations and any applicable sector-specific EU rules.
  • Review of your risk assessment approach and the supporting evidence you plan to rely on.
  • Technical documentation checks for completeness, internal consistency, and marketplace-friendly presentation.
  • Secure documentation storage and fast retrieval for market surveillance requests.
  • EU Responsible Person support, and EU Authorised Representative support where applicable.
  • Liaison support with national market surveillance authorities, aligned with the Market Surveillance Regulation (EU) 2019/1020 (MSR) role requirements.

See our services, or contact us to discuss your product, your current evidence, and the quickest path to a defensible GPSR compliance file.

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