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.
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PPE
Orthopaedic insoles (also called inlays or podiatric insoles) and semi-orthopaedic insoles worn in conjunction with work footwear or safety footwear are considered personal protective equipment. This means they must comply with the European Personal Protective Equipment (PPE) 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 standard EN-ISO 20345:2022 for safety footwear or EN-ISO 20347:2022 for work footwear without a safety .
MDR
Orthopaedic and semi-orthopaedic insoles are medical devices because they help (preventively) deal with 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 from our staff.
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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.