Laws and regulations for individual orthopaedic insoles
Regulation EU/2017/745 for Medical Devices (MDR)
Neskrid 4Allbrands individual orthopaedic insoles are certified as medical devices in accordance with Risk Class I of Regulation EU/2017/745 for Medical Devices (MDR). Within the framework of this MDR regulation, the manufacturer Neskrid and its 4Allbrands orthopaedic footwear solutions are mandatorily registered as medical devices in the European registration system EUDAMED under SRN registration number: NL-MF-000000434.
Neskrid 4Allbrands certified individual orthopaedic insoles have a CE mark according to MDR-Regulation EU/2017/745 for Medical Devices. In accordance with this MDR-Regulation, no declaration of conformity is possible for 4Allbrands individual orthopaedic insoles and therefore not available.
Regulation EU/2016/425 for Personal Protective Equipment (PPE)
Neskrid has for work and safety footwear the ultimate goal to create with 4Allbrands individual orthopaedic insoles a safe and healthy work situation for users of the occupational footwear.
What is special about Neskrid's individual orthopaedic insoles in the context of 4Allbrands is that they have been tested in combination with the work and safety footwear in which they can be used. This is because the reality in the market when using individual orthopaedic insoles is that either the owner of the occupational footwear itself or a foot specialist hired by the owner applies the individual orthopaedic insoles. In fact, therefore, either the owner or the foot specialist can thereby (substantially) modify the personal protective equipment, as a result of which these parties could formally become manufacturers of the new combination of occupational footwear and individual orthopaedic insoles.
Neskrid as manufacturer of the individual orthopaedic insole wishes to make its individual orthopaedic insoles as widely available as possible and thus achieve the ultimate 4Allbrands goal. Therefore Neskrid has chosen to support the owner of the professional footwear and the foot specialist in their (legal) position through the possibilities and knowledge of Neskrid.
Neskrid's support of the owners of occupational and safety footwear or the foot specialists sees, among other things, in verifying whether the new combination of occupational footwear and individual orthopaedic insoles comply with Regulation EU/2016/425 and harmonized standards. These harmonized standards are:
- NEN-ISO-EN 20347 for occupational footwear without a protective toecap
- NEN-ISO-EN 20345 for safety footwear with protective toecap
Within 4Allbrands, Neskrid carries out continuous testing for this purpose at an accredited European body to examine the compatibility and safety of the individual orthopaedic insoles with a particular model of a manufacturer.
Preferably, Neskrid works together with the relevant manufacturers and importers of occupational footwear for this purpose in order to jointly achieve the 4Allbrands goal. Meanwhile, a large number of manufacturers have joined the 4Allbrands concept. Hereby manufacturers and importers are also offered the possibility to develop and purchase, besides the 4Allbrands individual orthopaedic insoles, also individual orthopaedic insoles as Private Label for their brand for their work and safety footwear.