The General Product Safety Regulation (GPSR) is a comprehensive framework designed to ensure the safety of consumer products sold within the European Union. One of the key requirements under the GPSR is the compilation of a technical file for products. This article explores whether a technical file is required for general products to achieve GPSR compliance.

What is a Technical File?

A technical file is a collection of documents that provide detailed information about a product’s design, manufacturing process, and safety features. It serves as evidence that the product meets the necessary safety standards and regulations. The technical file typically includes:

• General description of the product and its essential characteristics
• Risk analysis and mitigation measures
• Test reports and toxicological assessments (if applicable)
• List of relevant European standards followed (if any)
• Labels and Instructions for Use (IFUs)

Why is a Technical File Important?

A technical file is crucial for several reasons:

1. Regulatory Compliance: It demonstrates that the product complies with the GPSR and other relevant regulations.
2. Safety Assurance: It ensures that the product has undergone thorough safety assessments and meets quality standards.
3. Market Access: It is a mandatory requirement for placing products on the EU market.
4. Consumer Trust: It enhances consumer confidence by showing a commitment to safety and quality.
5. Legal Responsibility: The manufacturer or importer is legally responsible for maintaining the technical file and making it available to market surveillance authorities.

Who Needs a Technical File?

Any manufacturer, importer, or distributor of general consumer products intended for the EU market needs to compile a technical file. This includes products that are not covered by specific regulations or directives. Examples include furniture, gym equipment, and children’s products.

Conclusion

In summary, a technical file is indeed required for general products to achieve GPSR compliance. It is a critical component that ensures products meet safety standards, facilitates market access, and builds consumer trust. Manufacturers and sellers must ensure that their technical files are comprehensive, up-to-date, and readily accessible to comply with the GPSR.

If you need assistance with creating a technical file or ensuring GPSR compliance, consider reaching out to experts in regulatory compliance, such as ASTA Certification, who can provide specialized services to help you navigate the requirements.