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CE Marking for Medical Devices

In order to place a medical device on the EU market, it has to be CE marked.

Ensuring Quality and Safety in the
Medical Device Industry - CE marking

CE marking indicates that a medical device (incl. software as a medical device (SaMD)) complies with the applicable European Union (EU) legislation, particularly the Regulation (MDR) (EU) 2017/745 on Medical Devices (MDR) or the Regulation (IVDR) (EU) 2017/746 on In Vitro Diagnostic Devices (IVDR). It’s mandatory for all medical devices.

Key benefits of
CE marking

Access to the Entire EU/EEA Market

CE marking enables unrestricted medical device sales across all EU and EEA member countries without additional approvals.

Demonstrates High Safety and Quality Standards

It proves the device meets stringent EU safety, performance, and clinical requirements, building trust with users.

Builds Global Trust and Supports International Sales

Recognized internationally, CE marking supports easier global market entry and strengthens worldwide commercial opportunities.

Enhances Brand Reputation and Competitive Advantage

CE marking enhances brand credibility, demonstrating regulatory compliance and differentiating products from non-certified competitors.

Supports Legal Compliance and Reduces Regulatory Risk

It reduces regulatory risks by ensuring compliance with EU laws, preventing penalties, recalls, and market disruptions.

  • How to obtain the
    CE mark for medical devices

    1. Determine Device Classification:
      Based on risk: Class I (+ im, Is), IIa, IIb, III (MDR) or A, B, C, D (IVDR)

    2. Appoint a European Authorized Representative (if non-EU manufacturer)

    3. Implement a Quality Management System (e.g., acc. to ISO 13485)

    4. Conduct a Conformity Assessment:
      Involves technical documentation and, for higher-risk devices, a Notified Body review

    5. Compile Technical Documentation:
      Clinical evaluation, risk management, labeling, and instructions for use

    6. Draft a Declaration of Conformity (DoC):
      Manufacturer declares compliance with EU requirements

    7. Affix the CE Mark:
      Include the 4-digit Notified Body number if applicable

Tadej Borštnar

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