CE Marking is a mandatory conformity marking for medical devices sold in the European Economic Area, indicating compliance with EU health, safety, and environmental requirements.
Complete Guide to CE Marking
CE Marking (Conformitรฉ Europรฉenne) is a mandatory certification mark for medical devices sold within the European Economic Area (EEA). It indicates that the product meets EU health, safety, and environmental protection requirements.
What CE Marking signifies:
- Compliance with applicable EU directives and regulations
- The manufacturer has completed required conformity assessment
- Product is safe for its intended use
- Technical documentation is available for inspection
CE Marking process for medical devices:
1. Classify the device according to EU MDR rules
2. Prepare technical documentation including clinical evidence
3. Implement Quality Management System (ISO 13485)
4. Engage a Notified Body (for Class IIa, IIb, III devices)
5. Complete conformity assessment procedure
6. Affix CE Mark and issue EU Declaration of Conformity
Device classes and Notified Body involvement:
- Class I - Self-declaration (sterile/measuring require NB)
- Class IIa - Notified Body certification required
- Class IIb - Notified Body certification required
- Class III - Notified Body certification with design dossier review
EU MDR vs MDD: Since May 2021, the Medical Device Regulation (EU MDR 2017/745) replaced the Medical Devices Directive (MDD 93/42/EEC), introducing stricter requirements for clinical evidence, post-market surveillance, and traceability.
CE Marking validity: Certificates are valid for up to 5 years and must be renewed through the Notified Body.
Related Terms
More Compliance & Standards
View allThe FDA's Quality System Regulation (QSR) that establishes current Good Manufacturing Practice (cGMP) requirements for medical device manufacturers in the United States.
A systematic, independent examination of a Quality Management System to determine whether quality activities and results comply with planned arrangements and whether these arrangements are implemented effectively.
A systematic approach to investigating, correcting, and preventing quality problems in medical device manufacturing and operations.
The systematic process under EU MDR to demonstrate that a medical device meets all applicable requirements and is safe and performs as intended.
Need Help with EU Registration?
Pure Global provides regulatory consulting and AI-powered tools to help medical device companies navigate EU market access.