Laws and regulations

Laws and regulations

The solutions provided by 4Allbrands are medical devices that are frequently used in combination with Personal Protective Equipment (PPE). For this reason, our products comply with the requirements of both relevant Regulations.

PPE

Work and safety footwear fall under the category of personal protective equipment. Wearing (semi-)orthopaedic insoles in such footwear may affect the protective properties of the shoe. As a result, the full combination of insole and work or safety footwear must comply with the European PPE Regulation EU/2016/425.

To ensure your safety and official certification, 4Allbrands insoles are tested by an accredited institute in accordance with the applicable standards for the relevant footwear. Whether you use safety footwear (EN-ISO 20345:2022) or work shoes without a safety toe cap (EN-ISO 20347:2022): 4Allbrands offers maximum comfort without compromising the legal protection required in the workplace.

MDR

Orthopaedic and semi-orthopaedic insoles are medical devices that provide (preventative) support for a wide range of foot complaints. To guarantee safety and quality, all 4Allbrands insoles strictly comply with the European Medical Device Regulation EU/2017/745 (MDR).

Furthermore, our solutions are officially registered in EUDAMED. Our unique SRN registration number is available upon request through our advisors.

Use of (semi-)orthopaedic insoles in protective footwear

Did you know that you cannot simply replace the insoles in work or safety shoes?

As soon as the original insole is replaced, the combination of the shoe and the new insole often no longer complies with statutory health and safety requirements. To ensure regulatory compliance, the combination must be certified according to European Regulations EU/2016/425 (Personal Protective Equipment) and EU/2017/745 (Medical Devices).

Are you curious about how these regulations work and how 4Allbrands (semi-)orthopaedic insoles can be used in compliance with the rules in combination with all models of work and safety shoe brands?

MAAK Advocaten (MAAK Attorneys) has drafted a comprehensive legal document. This document clearly explains the legislation and how the use of our (semi-)orthopaedic insoles within protective footwear is officially permitted under the regulations.


Furthermore, 4Allbrands (semi-)orthopaedic insoles have been tested and approved by the Netherlands Labour Authority and the German Bayerische Gewerbeaufsicht. Would you like to learn more about this?

What can we offer you?

Do you have specific questions regarding our certified solutions or the application of current regulatory standards? Please complete the contact form. Our specialists will get in touch shortly to provide expert advice tailored to your requirements.