Orthopaedic Footwear

We have been testing and certifying everything to do with foot protection for almost 40 years.

Orthopaedic footwear is a medical device designed for the prevention, control,
treatment or attenuation of a disease, to compensate for a wound or handicap.

The safety of orthopaedic footwear must be evaluated by identifying the dangers
and estimating the associated risks, according to the procedures defined in ISO 14971.

How to proceed

The product must comply with the provisions of Regulation (EU) 2017/745. Our laboratories verify conformity according to the following standards:

UNI 11533

Mass-produced orthopaedic footwear designed for foot orthotic – Safety and performance requirements and test methods

EN ISO 10993-1

Biological evaluation of medical devices: Evaluation and testing

EN ISO 10993-5

Biological evaluation of medical devices: in vitro cytotoxicity testing

EN ISO 10993-10

Biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity

EN ISO 10993-18

Biological evaluation of medical devices: Chemical characterization of medical device materials within a risk management process

When testing is complete, you will have to:

  • prepare the technical file in compliance with Annex II to Regulation (EU) 2017/745
  • apply the CE marking on the Medical Device
  • prepare the EU declaration of conformity (conforming to Annex IV to Regulation (EU) 2017/745), complete with an indication of the SRN (supplier’s unique code) and UDI D (device’s unique code)
  • register with the Database of the Ministry of Health and the European EUDAMED

Intervention from a notified body is only required if the footwear is designed to come into contact with broken skin (Category IIa).

Keep the EU declaration of conformity and the technical file for 10 years from when the Medical Device is placed on the market.

For complains, claims or notifications, fill in form M33 and send it to qualita@cimac.it.

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