Exoskeleton Regulation at Work: What Employers Need to Know

Introduction: a regulatory framework made of several pieces

Is a work exoskeleton personal protective equipment? A machine? A medical device? The answer depends on the product and on what its manufacturer claims. There is no single "exoskeleton law": employers rely on general prevention rules, plus a few texts and standards depending on the type of device.

This article summarizes what official sources say, in particular INRS (France's national research and safety institute). It is not legal advice: if in doubt, contact your occupational health and prevention service. Some of the sources cited date from 2018; texts evolve, so always check their current status.

 

Chapter 1: the texts that may apply

• The French Labour Code, first. Employers must assess risks and record the result in the single occupational risk assessment document (articles L4121-1 and following). The Code also sets general prevention principles, including giving priority to collective protection measures over individual ones.

• EU machinery law. According to INRS, only robotized exoskeletons fall under the Machinery Directive 2006/42/EC; non-robotized models built only from mechanical elements (springs, elastics) do not. Regulation (EU) 2023/1230 replaces that directive and applies from January 2027.

• Personal protective equipment (PPE). In its FAQ, INRS stated that work exoskeletons were not PPE, for lack of demonstrated effectiveness against a specific risk. The manufacturer must state in its declaration of conformity which texts it places its product under.

• Medical devices. An exoskeleton with a medical purpose (rehabilitation, compensating a disability) falls under Regulation (EU) 2017/745, a very different certification route.

• Voluntary standards. They are not mandatory but serve as a reference: see chapter 3.

 

Chapter 2: what the employer must do

According to INRS, an exoskeleton used at work must be included in the occupational risk assessment and recorded in the single risk assessment document. In practice:

• Start with workstation design. Before equipping workers, favor technical, organizational and collective measures (handling aids, reorganization, workstation layout). An exoskeleton does not replace prevention at the source.

• Define the goal. The employer defines and clearly communicates what the equipment is expected to achieve, putting workers' health ahead of productivity gains.

• Involve the right people. The occupational health and prevention service and staff representatives should be involved.

• Monitor over time. Assess effects in the short, medium and long term: health indicators, user acceptance, comfort, maintenance.

 

Chapter 3: the NF X35-800 standard (2023)

Published in August 2023, the French standard NF X35-800 describes an integration method for physical assistance devices of the exoskeleton type: needs definition, selection, design, evaluation and deployment. It targets user organizations as well as designers and integrators, in all sectors.

Two limits to keep in mind: it is a voluntary standard, and it covers professional use only. It does not cover medical, sport or leisure uses, and it is not a quality certification of exoskeletons.

At the international level, ISO 13482 sets safety requirements for personal care robots, including non-medical restraint-type exoskeletons. Researchers have noted that it does not address every use case: compliance does not rule out all risk.

 

Chapter 4: the risks specific to exoskeletons

INRS reminds us that an exoskeleton can itself create risks: the usual machine risks (mechanical, electrical, thermal, noise and vibration for powered models), but also constraining postures, stress, cognitive fatigue, proprioceptive disorders, and loss of balance or falls. Hence the importance of a trial at the real workstation before any deployment.

 

Chapter 5: what to ask the manufacturer before buying

• The declaration of conformity and the texts or standards the product is placed under.

• The intended scope of use: which movements, which loads, which body types.

• The manual and training for use, plus maintenance instructions.

• The on-site trial conditions before purchase.

• The available data on effectiveness: ask for the source, and compare it with INRS's reservations about the lack of scientific proof of a reduction in musculoskeletal disorders.

On our product pages, the certifications shown (CE, etc.) are those stated by the manufacturers: we do not verify them independently (see our methodology).

 

Frequently asked questions

Is an exoskeleton required or recommended by law?

No. No text requires an exoskeleton. The law requires employers to assess and prevent risks; an exoskeleton is only one possible solution, to be considered after collective and organizational measures.

Does it need to be recorded in the single risk assessment document?

Yes. According to INRS, an exoskeleton used at a workstation must be included in the risk assessment and recorded in that document.

Is an exoskeleton PPE?

According to INRS's FAQ (2018), work exoskeletons were not considered PPE for lack of demonstrated effectiveness against a defined risk. Ask the manufacturer under which regime it classifies its product.

Is the NF X35-800 standard mandatory?

No, it is a voluntary standard. It provides an integration method for professional settings, but does not certify a product.

Does an exoskeleton prevent musculoskeletal disorders?

INRS pointed out in its FAQ the lack of established scientific proof of a reduction in musculoskeletal disorders. An exoskeleton can relieve a specific movement, but it does not replace improving the workstation.

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Sources

• INRS: Exoskeletons, frequently asked questions (French)
• INRS: Exoskeletons, key takeaways (French)
• INRS: 10 misconceptions about exoskeletons, ED 6295 (French)
• INRS: NF X35-800, exoskeleton integration method (French)
• EU-OSHA: Regulation (EU) 2023/1230 on machinery

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