Laws and regulations semi-orthopaedic insoles

Regulation EU/2017/745 for Medical Devices (MDR)

Neskrid 4Allbrands semi-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 semi-orthopaedic insoles have a CE mark according to MDR-Regulation EU/2017/745 for Medical Devices. In accordance with this MDR-Regulation, the declaration of conformity is available for 4Allbrands semi-orthopaedic insoles.

Regulation EU/2016/425 for Personal Protective Equipment (PPE)

Neskrid has for work and safety footwear the ultimate goal to create with 4Allbrands semi-orthopaedic insoles a safe and healthy work situation for users of the professional footwear.

What is special about Neskrid's semi-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 semi-orthopaedic insoles is that either the owner of the work footwear itself or a foot specialist hired by the owner applies the semi-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 semi-orthopaedic insoles.

Neskrid as manufacturer of the semi-orthopaedic insole wishes to make its semi-orthopaedic insoles as widely available as possible and thus achieve the ultimate 4Allbrands goal. Therefore Neskrid has chosen to support the professional footwear owner and foot specialist in their (legal) position through Neskrid's capabilities and knowledge.

Neskrid supports the owners of work and safety footwear or foot specialists. For example, we oversee the verification that the new combination of occupational footwear and semi-orthopaedic insoles comply with Regulation EU/2016/425 and harmonized standards. These harmonized standards are:

  • EN-ISO 20347 for occupational footwear without a protective toecap
  • EN-ISO 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 semi-orthopaedic insoles with a particular model of a manufacturer.

Preferably, Neskrid works together with the relevant manufacturers and importers of professional footwear for this purpose in order to achieve the 4Allbrands goal together. Meanwhile, a large number of manufacturers have joined the 4Allbrands concept. Hereby manufacturers and importers are also offered the possibility to develop and purchase semi-orthopaedic insoles as a Private Label for their brand for their work and safety footwear, in addition to the 4Allbrands semi-orthopaedic insoles.