Short answer
Regulation (EU) 2023/988, the General Product Safety Regulation, entered into force on 30 May 2023 and has applied to products placed on the EU market since 13 December 2024. It replaced Directive 2001/95/EC.
The practical shift for anyone importing massage devices is accountability. A non-EU manufacturer must have an EU-based economic operator, and if none is designated, the importer or distributor assumes legal responsibility for compliance. That is the sentence worth reading twice before you place an order.
A separate point that is widely misunderstood: the responsible person is a regulatory contact and documentation holder, not the party liable for consumer compensation. Liability for a defective product still rests with the manufacturer under Directive 85/374/EEC — unless you brand the product, in which case you may meet the definition of producer yourself.
Why private label changes your position
If you buy a factory-branded unit and distribute it, you are a distributor with documentation duties. If you put your own brand on the same unit, you can meet the definition of producer under EU law, and the liability analysis changes accordingly.
This is not an argument against private label. It is an argument for making sure the technical documentation is genuinely in order before your logo goes on the housing, because at that point the brand on the product is the name a consumer and an authority will both look for.
What the technical file must contain
Article 5 requires an internal risk analysis and technical documentation demonstrating conformity. The documentation is not a certificate; it is a file you must be able to produce on request.
For a massage device the hazard categories that matter are mechanical, thermal and electrical, plus chemical via the materials in contact with skin. A heated product needs the thermal analysis to address the maximum surface temperature and the behaviour of the temperature control if it fails.
| File element | What it must cover | Who normally supplies it |
|---|---|---|
| Economic operator identification | Manufacturer, authorised representative, importer, responsible person | Importer and factory jointly |
| Product description | Function, essential safety characteristics, composition, intended user age | Factory |
| Applicable standards list | Harmonised standards used, plus REACH and sector legislation | Factory with importer review |
| Hazard assessment | Mechanical, chemical, thermal, electrical, hygiene, radiation | Factory, validated by importer |
| Risk categorisation | Severity ranking and mitigation measures taken | Importer with factory input |
| Labelling and instruction review | Adequacy of warnings in each market language | Importer |
| Test reports | Evidence against the standards claimed | Factory or third-party laboratory |
Labelling obligations under Article 9
Article 9 requires a type, batch or serial number or other identifier that is clearly visible and legible on the product, and the manufacturer's name, registered trade name or trademark with a postal and email address.
Instructions and safety information must be in a language understood by consumers in each member state where the product is made available. That is a per-market requirement, not a single English manual, and it drives packaging artwork and print lead time.
QR codes and digital labels may complement these requirements but cannot replace the physical labelling. Several buyers have planned a digital-only approach and had to reprint.
- Product carries a visible type, batch or serial identifier
- Manufacturer name and postal plus email address present
- Instructions in the language of each destination member state
- Warnings and safety information on the product or packaging, not only online
- Article 19 also requires manufacturer details, product identification and warnings in the online listing
Incident reporting and the two-day clock
GPSR strengthened market surveillance through the EU Safety Gate, and it set a reporting expectation measured in working days rather than weeks: serious product safety risks must be notified within two working days.
That timescale only works if your supplier can trace a unit to a production batch quickly. Ask how batch traceability is implemented before you need it. A supplier who cannot tell you which batch a serial number belongs to cannot help you meet a two-day clock.
Great Britain is a separate exercise
GPSR applies to the EU market and Northern Ireland. Great Britain operates its own regime with UKCA marking, so a buyer serving both needs to confirm which marks and documentation each destination requires.
Treat them as two compliance files that share most of their technical content rather than as one file with two logos. The underlying test evidence is usually common; the conformity route and labelling are not.
What to request from us
We manufacture in Wenzhou and Anlu and hold FDA, UL, CE, RoHS, UKCA, KC and ISO 9001 certification across the massager range. For an EU programme, ask us for the model-specific test report, the material declarations, the UN38.3 test summary for the cell in your build, and the batch identification scheme we will apply to your order.
Where a certificate number exists, we give it to you so you can verify it independently — our EMS facial device carries CE certificate 00460AX0533CE, for example. We would rather you check than take a logo on trust.
Frequently asked questions
When did GPSR start applying?
Regulation (EU) 2023/988 entered into force on 30 May 2023 and has applied to products placed on the EU market since 13 December 2024, replacing Directive 2001/95/EC. Products compliant with the old directive and placed on the market before that date may continue to be made available.
Do we need an EU responsible person if we import directly?
A non-EU manufacturer must have an EU-based economic operator. If no authorised representative is designated, the importer or distributor automatically assumes legal responsibility for compliance. If you are the EU importer, that role can be yours, which means you hold the technical documentation and act as the contact point for authorities.
Is the responsible person liable if a consumer is injured?
Generally no. The responsible person or authorised representative is a regulatory contact and documentation holder. Liability for damage caused by a defective product rests with the manufacturer under Directive 85/374/EEC, unless another operator meets the definition of producer — which can happen if you brand the product as your own.
Does a CE mark mean the product is GPSR compliant?
Not by itself. A CE mark relates to the specific directives or regulations it was applied under. GPSR requires an internal risk analysis and a technical file covering foreseeable hazards and mitigation. Conformity with harmonised standards gives a presumption of conformity for the risks those standards cover, but you still need the documentation.
Does GPSR apply in the United Kingdom?
GPSR applies to the EU market and Northern Ireland. Great Britain has its own product safety regime using UKCA marking. If you serve both, plan two compliance routes that share technical test evidence but differ in conformity marking and labelling.
What do you supply for an EU compliance file?
Model-specific test reports, material declarations, the UN38.3 test summary for the lithium cell in your build, declared electrical and thermal parameters, and the batch identification scheme applied to your order. Request these at the quotation stage so artwork and documentation run in parallel with production.
Sources
- Regulation (EU) 2023/988 on general product safety (full text) — Applies from 13 December 2024
- EUR-Lex summary — General Product Safety Regulation — Accessed 7 October 2026
- European Commission — obligations for businesses (Safety Gate) — Accessed 7 October 2026
- European Commission — liability for defective products — Accessed 7 October 2026
- UK Government — medical devices conformity assessment and the UKCA mark — Accessed 7 October 2026
This article is general information, not medical advice. A therapeutic massager is intended to relieve minor muscle aches and pains; it does not diagnose, treat, cure or prevent any disease. Consult a qualified healthcare professional about your individual circumstances.