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 allA system of regulations, codes, and guidelines ensuring medical devices are consistently produced and controlled according to quality standards.
The international standard for quality management systems specific to medical device organizations.
A formalized system documenting processes, procedures, and responsibilities for achieving quality policies and objectives in medical device manufacturing.
A system to uniquely identify medical devices through distribution and use, using a standardized identifier on device labels and packages.
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