Laws and regulations

Laws and regulations

4Allbrands solutions are medical devices and are worn in conjunction with personal protective equipment. There are therefore two types of Regulations with which we must comply.

PPE

Orthopaedic insoles (also called orthotics or podiatric insoles) and semi-orthopaedic insoles worn in conjunction with work footwear or safety footwear are considered personal protective equipment (PPE). This means they must comply with the European Personal Protective Equipment Regulation EU/2016/425. To ensure that all 4Allbrands insoles comply with this, they are tested and approved by an accredited testing institute in accordance with the standards EN-ISO 20345:2022 for safety footwear or EN-ISO 20347:2022 for work footwear without a safety toe cap.

MDR

Orthopaedic and semi-orthopaedic insoles are medical devices because they help prevent or address various foot issues. As a result, they must comply with the European Medical Devices Regulation EU/2017/745 (MDR). This is why all 4Allbrands insoles are certified in accordance with this regulation.

All our 4Allbrands solutions are also registered as medical devices in the European registration system EUDAMED with their own SRN registration number. This registration number can be obtained by contacting our staff.

Use of (semi-)orthopaedic insoles in protective footwear

Did you know that it is not just permitted to replace insoles in work or safety shoes? The combination of the shoes and the new insoles no longer meets the legal requirements in the field of health and safety. To ensure that such a combination does comply with the regulations, it must comply with European Regulation EU/2016/425 (safety) and EU/2017/745 (health).

Are you curious about how this legislation exactly works and how 4Allbrands (semi-)orthopaedic insoles comply in combination with all models of brands of work and safety shoes? MAAK lawyers have prepared an extensive document explaining the legislation and how the use of (semi-)orthopaedic insoles in protective footwear is permitted within the regulations.


The (semi-)orthopaedic insoles of 4Allbrands have also been tested and approved by the Dutch Labour Inspectorate and the German Bavarian Trade Inspection. Would you like to read more about this?

What can we offer you?

We have extensive knowledge and expertise in testing, certification and orthopaedics. By combining these strengths, 4Allbrands is able to offer safe and certified solutions to (preventively) deal with foot issues. Want to know what 4Allbrands can offer you, your customer or your employees? Then complete the contact form. One of our employees will contact you as soon as possible.