Are exoskeletons medical devices?

Emely Nagel
Oct 6
3 min read

Exoskeletons are increasingly being used in various areas - from industry to rehabilitation. But the question arises: are exoskeletons actually medical devices?

Unser BionicBack Exoskelett — Our BionicBack exoskeleton is used in many sectors - from logistics to care.

When is an exoskeleton considered a medical device?

The categorisation of an exoskeleton as a medical device depends primarily on its intended use. While some exoskeletons are developed exclusively for industrial applications, there are others that are used specifically to support people with physical disabilities or for rehabilitation - and therefore fulfil the criteria for a medical device.

1. Definition depending on the intended use

Exoskeletons are classified as medical devices if they:

✔️ Specially developed for medical purposes (e.g. rehabilitation, support after injuries)

✔️ Provide targeted support for physical limitations

One example of this is exoskeletons that help patients relearn movements after a stroke or spinal cord injury.

2. Duthorisation and proof of safety required

Exoskeletons that are considered medical devices must undergo strict authorisation procedures. This includes proof of:

✔️ Safety for the user

✔️ Medical efficacy and benefit

This process ensures that the product fulfils the health and regulatory requirements and that the desired support is actually provided.

CE labelling in the EU

In the EU, exoskeletons that are classified as medical devices require CE labelling. This labelling confirms that the product:

✔️ Complies with the European directives for medical devices

✔️ Meets the specified standards for safety and performance

Our BionicBack bears the CE mark, which confirms its safety and quality - even though it is not classified as a medical device, but as a supportive aid for everyday working life.

Not all exoskeletons are medical devices

Exoskeletons developed for industrial or general physical support without a medical purpose are not considered medical devices. This includes, for example, exoskeletons used in logistics or the construction industry to reduce the physical strain of lifting and carrying.

➡️ Our BionicBack falls into this category - it is not used for medical treatment, but for the prevention of physical complaints and to improve working conditions.

Regulatory differences depending on the country

The categorisation of exoskeletons as a medical device also depends on the regulatory framework of the respective country. While CE labelling is decisive in the EU, the requirements of the FDA (Food and Drug Administration) apply in the USA, for example.

How the BionicBack helps

Although the BionicBack is not a medical device in the legal sense, it nevertheless has a preventive and supportive effect:

Reduction of strain on muscles and joints
Support for repetitive movements and lifting heavy loads
Improve posture and relieve strain on the back

The BionicBack contributes to the prevention of musculoskeletal disorders and to the long-term health of employees, particularly in the working environment.

The most important points at a glance

✅ Exoskeletons are considered medical devices if they are used specifically for medical purposes.

✅ Medical devices require authorisation and CE marking.

✅ Exoskeletons for industry and physical support without a medical purpose are not medical devices.

The BionicBack has CE labelling and has a preventive effect in everyday working life.

✅ The regulatory requirements vary depending on the country.

Conclusion

To cut a long story short: Some exoskeletons are medical devices, others are not. The decisive factor is the intended use. While medical exoskeletons are primarily used in rehabilitation, industrial exoskeletons such as our BionicBack specifically support physical performance and help to prevent overuse. Regardless of the classification, exoskeletons make a real difference - whether in rehabilitation or in the workplace.

Everything at a glance in our YouTube video: