CE Marking

Step-by-Step Guide to Getting CE Marking for Medical Devices in the EU

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Introduction

CE Marking is a mandatory conformity mark for medical devices sold in the European Economic Area (EEA). It signifies that your product complies with the EU Medical Device Regulation (EU MDR 2017/745). If you’re a medical device manufacturer looking to access the European market, obtaining CE Marking is a critical step.

In this blog, we provide a complete, step-by-step guide to help you achieve CE Marking for medical devices in compliance with EU regulations.

Step 1: Determine the Medical Device Classification

The first step is to identify the correct classification of your medical device under EU MDR. Devices are classified based on risk into four categories:

  • Class I – Low risk (e.g., bandages)
  • Class IIa – Medium risk (e.g., dental fillings)
  • Class IIb – Higher risk (e.g., infusion pumps)
  • Class III – Highest risk (e.g., pacemakers)

Why it matters: Your device class determines the regulatory pathway and whether you need a Notified Body assessment.

Step 2: Prepare Technical Documentation

The technical documentation (or Technical File) must demonstrate that your device meets the General Safety and Performance Requirements (GSPRs) under EU MDR.

Key components include:

  • Device description and intended use
  • Risk management file (ISO 14971)
  • Clinical evaluation report (CER)
  • Design and manufacturing information
  • Labeling and instructions for use (IFU)
  • Post-market surveillance plan

Tip: A complete and compliant Technical File is essential for regulatory approval and audit readiness.

Step 3: Choose a Notified Body (If Required)

For Class Is (sterile), Im (measuring), Ir (reusable surgical instruments), and all higher classes, you must work with a Notified Body—an independent organization designated by the EU.

They will:

  • Review your documentation
  • Audit your quality management system (QMS)
  • Issue a CE certificate upon compliance

Note: Class I (non-sterile, non-measuring) devices do not require Notified Body involvement.

Step 4: Conduct Conformity Assessment

The conformity assessment route depends on your device class:

  • Class I: Self-declaration with Technical Documentation
  • Class IIa/IIb/III: Involves QMS audit and technical file review by a Notified Body

Common conformity assessment procedures:

  • Annex IX – QMS and design dossier
  • Annex XI – Production quality assurance

Important: Implement ISO 13485-compliant QMS to meet EU MDR standards.

Step 5: Draft and Sign the EU Declaration of Conformity

Once compliance is achieved, you must issue the EU Declaration of Conformity (DoC) stating that the device meets all regulatory requirements.

It must include:

  • Manufacturer’s details
  • Device classification
  • Applicable standards and regulations
  • Notified Body information (if applicable)

The DoC must be signed by the manufacturer’s authorized representative.

Step 6: Affix the CE Marking to Your Device

Now you can affix the CE mark on your device, packaging, and user instructions.

Key rules:

  • Must be visible, legible, and indelible
  • Include the Notified Body number if applicable

Warning: Affixing the CE mark without proper compliance is illegal and can lead to severe penalties.

Step 7: Register Your Device in EUDAMED

Under EU MDR, manufacturers must register their devices and economic operators in EUDAMED, the European medical device database.

  • Obtain a Single Registration Number (SRN)
  • Upload device and manufacturer details
  • Ensure continuous data updates

Note: Device registration is mandatory before placing the product on the EU market.

Step 8: Maintain Compliance with Post-Market Obligations

After CE marking, you must continuously monitor product safety and performance.

Key post-market requirements:

  • Post-Market Surveillance (PMS)
  • Vigilance and incident reporting
  • Periodic Safety Update Reports (PSURs)
  • PMCF (Post-Market Clinical Follow-up)

Compliance is not a one-time task—maintain your QMS and documentation proactively.

Why Choose Operon Strategist Netherlands for CE Marking Support?

At Operon Strategist Netherlands, we help manufacturers navigate the complex EU MDR landscape and achieve CE certification efficiently. Whether you’re a startup or an established manufacturer, we offer:

  • End-to-end CE marking consultancy
  • Technical documentation and QMS implementation
  • Notified Body coordination and audit support
  • Post-market surveillance planning

Ready to Get CE Marking for Your Medical Device?

Contact Operon Strategist Netherlands today for a consultation. Let’s make your product EU-compliant and market-ready!