European CE Marking Strategy for Medical Devices

The CE mark for medical devices confirms compliance with essential regulations for entry into European countries.

Operon Strategist, a leading CE marking consultant, boasts a substantial presence throughout the EU, extending our support to countless medical device manufacturers to ensure CE compliance for Europe.

CE Mark for Medical Devices

What Is the European CE Mark for Medical Devices?

The CE mark is a symbol indicating compliance with European Union (EU) regulations, confirming that a medical device meets strict standards for safety, quality, and performance. It serves as a prerequisite for accessing the European market.

How to Obtain European CE Mark for Your Medical Device

To achieve CE marking for your medical device, compliance with EU Medical Devices Regulation (MDR 2017/745) is crucial. The process typically includes:

  1. Determining device classification based on MDR definitions.
  2. Implementing a Quality Management System (QMS), commonly ISO 13485.
  3. Preparation of technical documentation, including a Clinical Evaluation Report (CER) in line with MEDDEV 2.7/1 rev4 and MDR standards.
  4. Appointment of a European Authorized Representative (EC REP) if lacking a physical presence in Europe.
  5. Collaboration with a Notified Body for QMS and technical documentation audits (required for certain device classes).
  6. Obtaining CE Marking and ISO 13485 certificates from the Notified Body.
  7. Drafting a Declaration of Conformity (DoC) stating compliance with MDR.

Countries Accepting CE Marking for Medical Devices

Several countries, including those within the European Economic Area (EEA) and special cases like Switzerland and Turkey, mandate CE marking for medical devices to access their markets.

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Operon Strategist's Assistance for EU CE Marking Compliance

Operon Strategist, an expert in EU Medical Devices Regulation (MDR), provides comprehensive services to support manufacturers:

  • Guidance on product classification.
  • Verification of applicable standards and testing requirements.
  • Compilation or review of technical files and existing documentation.
  • Ensuring compliance of marketing materials and user manuals.
  • Assistance with Essential Requirements adherence.
  • Crafting Clinical Evaluation Reports based on provided data.
  • Implementation and maintenance of ISO 13485-compliant QMS.
  • European Authorized Representative services.
  • Risk assessment following ISO 14971.
  • Development of post-market surveillance procedures.

Contact Operon Strategist to learn how we can assist you in obtaining CE marking for your medical device in Europe.