Personal Protective Equipment (PPE)

To sell personal protective equipment (PPE) in the European Union, your products must comply with the Personal Protective Equipment Regulation.

Most importantly, the PPE Regulation falls under the scope of the Market Surveillance Regulation. This implies that manufacturers must have an economic operator based in the EU, such as the authorised representative.

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Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.