Glossary Term
CE Marking
Definition
CE Marking is a certification that indicates a product meets the safety, health, and environmental protection standards required for sale in the European Economic Area (EEA). For medical devices, CE Marking signifies compliance with the EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring the device is safe, effective, and fit for its intended purpose.
Relevance to the MedTech Industry
CE Marking is essential for market access in the EEA, providing assurance to regulators, healthcare professionals, and patients that the device complies with EU standards. It supports transparency, safety, and quality in the distribution of medical technologies, enabling manufacturers to sell their devices in one of the world’s largest healthcare markets.
Additional Information & Related Terms
EU MDR Governs the CE Marking process for medical devices.
Notified Body An independent organization that assesses compliance with EU regulations.
Technical File Documentation required for CE Marking to demonstrate conformity with regulations.
Post-Market Surveillance Ongoing monitoring to maintain CE Marking compliance.