Laws and regulations on individual orthopaedic adaptations  

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

Neskrid 4Allbrands individual orthopaedic footwear adaptations, abbreviated OVAC, 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 footwear adaptations 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 adaptations to footwear and therefore not available.

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

The work or safety footwear in which Neskrid applies the 4Allbrands individual orthopaedic adaptations to footwear is a personal protective equipment and as such certified according to Regulation EU/2016/425 for Personal Protective Equipment (PPE). Within the framework of this PPE Regulation, the occupational footwear in which 4Allbrands individual orthopaedic adaptations to footwear are applied is tested and approved at an accredited European body on the basis of harmonized standards for:

  • EN-ISO 20347 for occupational footwear without a protective toecap
  • EN-ISO 20345 for safety footwear with toe cap

The occupational footwear in which Neskrid the 4Allbrands has made individual orthopaedic adjustments to footwear and is certified as a combination retains the original CE mark of the manufacturer of the occupational footwear. In addition, the occupational footwear shall bear an additional CE marking on the insole in accordance with MDR Regulation EU/2017/745 for Medical Devices.