CE Marking Process Explained: How to Get Certified in the EU
For medical device companies, the CE mark is more than a label — it’s the key to entering the European market. But how does the certification process actually work? This guide breaks down the CE marking journey step by step.
What is CE Marking?
CE marking shows that a medical device complies with the European Union’s safety, health, and performance standards. It’s mandatory for all devices sold in the EU and symbolizes that a product meets the requirements of the Medical Device Regulation (MDR).
Step-by-Step CE Marking Process
1. Determine the Applicable Regulation
- Is your device under MDR (EU 2017/745) or IVDR (EU 2017/746 for in-vitro diagnostics)?
- Correct classification at the start is critical.
2. Classify Your Device
- Devices are classified as Class I, IIa, IIb, or III.
- Higher classes involve stricter controls and require a Notified Body.
3. Establish a Quality Management System (QMS)
- A QMS aligned with ISO 13485 is essential.
- Ensures traceability, documentation, and risk management.
4. Prepare Technical Documentation
Your file should include:
- Product design and specifications
- Risk analysis and mitigation
- Clinical evaluation data
- Instructions for use and labeling
5. Engage a Notified Body (if required)
- For most Class II and III devices, a Notified Body must review and certify your documentation.
- They perform audits and issue the conformity certificate.
6. Register in EUDAMED
- Devices must be uploaded to the EUDAMED database with a Unique Device Identification (UDI) for full traceability.
7. Affix the CE Mark
- Once certified, the CE mark can be placed on the device, packaging, and promotional materials.
Why CE Marking is Important
- Mandatory for Market Access: Without CE marking, products cannot be sold legally in the EU.
- Global Recognition: Many countries view CE marking as proof of compliance.
- Patient Trust: A CE-certified product shows commitment to safety and quality.
- Business Advantage: Opens doors to partnerships with hospitals, clinics, and distributors.
Common Pitfalls to Avoid
- Incorrect device classification.
- Missing or weak clinical data.
- Incomplete technical files.
- Late engagement with a notified body.
Conclusion
The CE marking process may seem complex, but with the right approach, it becomes manageable. For medical device companies, achieving CE certification is not only about compliance — it’s about proving reliability, ensuring patient safety, and unlocking growth opportunities in the EU and beyond.
