How do you check that an exoskeleton complies (CE marking)?

The answer in detail

CE marking means the manufacturer declares its product complies with the requirements of the European texts that concern it. It is not a label issued by an authority: in most cases the manufacturer affixes it itself, after assessing its product.

For an exoskeleton, everything depends on the applicable text. INRS states that it is not personal protective equipment, and that the Machinery Directive concerns only robotized models. The pages of our Hypershell, Hapo and Dnsys products mention CE marking, with different references.

What you can check yourself

• Marking: present on the product, the label or the packaging, legible and unaltered.
• Declaration of conformity: a manufacturer's document, naming the directives or regulations applied.
• References: Hapo pages cite Directive 2006/42/EC; Hypershell mentions CE, RoHS and FCC.
• Medical status: only medical use falls under the medical devices regulation, with classes I to III.

The European medical devices regulation, described by ANSM, also requires tracking through the EUDAMED database. Read our question on medical device status.

Step-by-step instructions

1. Look for the CE marking on the product and in the documentation.
2. Ask the manufacturer for the declaration of conformity, in writing.
3. Check that the texts cited match the type of product.
4. Check the name, address and contact details of the manufacturer or importer in the European Union.
5. Keep the declaration with the invoice, useful in a dispute or for professional use.

Limits and precautions

• CE marking is a manufacturer's declaration, not an independent test.
• A product can bear a marking without the declaration being produced: ask for it.
• A CE marking says nothing about the claimed effectiveness, and even less about comfort.
• For professional use, the employer must follow the framework of its own sector.

The workplace framework is presented in our article on exoskeleton regulation.

Common mistakes

These confusions are common because the CE symbol inspires trust without being a guarantee of performance.

• Confusing CE marking with a quality label or independent certification.
• Confusing CE, RoHS and FCC: they are three different references, covering distinct subjects.
• Accepting a simple logo on a web page without having asked for the declaration of conformity.
• Forgetting to check that the seller is actually located in the European Union.

Key takeaways

To check an exoskeleton's compliance, look for the CE marking then ask for the manufacturer's declaration of conformity, checking the texts cited. The marking remains a manufacturer's declaration and proves neither effectiveness nor safety in all circumstances. If in doubt about a medical use, ask a professional: this is not medical advice. To compare models, read our buying guide.

Sources

• ANSM: key points of the European medical devices regulation (in French)
• INRS: exoskeletons, frequently asked questions (in French)