Orthopaedic Footwear:

Testing and Certifications

Orthopaedic footwear is a medical device designed for the prevention, monitoring, treatment, or alleviation of a disease, and the compensation for an injury or disability.The safety of orthopaedic footwear must be evaluated by identifying hazards and estimating their associated risks, according to the procedures defined in ISO 14971.

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Contact a CIMAC Consultant. Book a 15-minute slot with a technician.

HOW CERTIFICATION WORKS

Certification process: from sample to certificate

A clear 5-step process, estimated timelines, and required documents to achieve CE marking.

  • 1) Pre-assessment:
    Product and standards; category I/II/III and modules (B; C2/D). Testing plan, checklist, and timelines.
  • 2) Sample Submission:
    Representative samples + Bill of Materials (BOM), instructions, and forms. Fast-track intake.
  • 3) Testing/Verification:
    Tests according to current standards. Clear updates; targeted corrections if required.
  • 4) Reporting:
    Test and evaluation report; ready for the DoC and Technical File.
  • 5) Certification / Surveillance:
    EU Type-Examination Certificate (Module B) valid up to 5 years; annual C2 or D surveillance (Cat. III). Retain DoC and Technical File for 10 years.
Frequently Asked Questions
Frequently Asked Questions (FAQ)

For over 40 years, CIMAC has been testing and certifying safety footwear (PPE) in accordance with Regulation (EU) 2016/425 and current harmonised standards (e.g., EN ISO 20345/46/47).

We cover the entire range: safety shoes, firefighter boots, chainsaw-resistant footwear, foundry and welding boots, electrically insulating boots, motorcycling footwear, and chemical protection. Clear pathways, sample checklists, and technical support through to CE marking.

Validity of Certifications and Document Retention

Retain the EU Declaration of Conformity and technical documentation for 10 years from the date the PPE is placed on the market. The EU Type-Examination Certificate (Module B) has a maximum validity of 5 years from the date of issue, unless the reference harmonised standard is revised. Module C2 and Module D are subject to annual surveillance.

Orthopaedic footwear is generally classified as a Class I Medical Device under Regulation (EU) 2017/745 (MDR), as it is intended to prevent, treat, or alleviate foot pathologies and disabilities.

We support you in verifying the correct intended use and in preparing the EU Declaration of Conformity. Our goal is to provide constant assistance to validate the product in the shortest possible time.

Device safety must be evaluated by identifying every potential hazard (mechanical, chemical, or ergonomic) and estimating the associated risks for the user.

We assist you in applying ISO 14971 procedures, helping you document the measures taken to reduce risks to acceptable levels. We provide dedicated technical support to structure a robust and compliant analysis quickly.

In addition to clinical evaluation, it is essential to test the biocompatibility of materials in contact with the skin and the mechanical strength of components (soles, uppers, closure systems).

We perform specific tests to ensure the device maintains its corrective properties during prolonged use. We guarantee constant technical assistance to verify every performance requirement in the shortest possible time.

Custom-made devices follow a specific procedure requiring a detailed medical prescription and technical documentation identifying the individual patient.

We support you in creating the documentary management system needed to track the design and manufacture of the device, ensuring that every unique piece meets essential safety requirements and reaches the end user in the shortest possible time.

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