The CE marking for medical devices is a certification indicating that a product complies with the European Union’s health, safety, and environmental protection requirements. It is a mandatory requirement for medical devices to be placed on the market or distributed within the European Economic Area (EEA).
The CE mark confirms that the device meets the requirements specified in the relevant EU regulations, primarily:
Medical Device Regulation (MDR, EU 2017/745)
In Vitro Diagnostic Regulation (IVDR, EU 2017/746)
Medical devices are classified into four risk-based categories:
Class I (low risk)
Class IIa
Class IIb
Class III (high risk)
The classification determines the applicable conformity assessment route.
For Class I devices: Manufacturers may self-declare conformity, provided the device is neither sterile nor has a measuring function.
For higher-risk devices (Class IIa, IIb, III): A Notified Body must conduct a conformity assessment. A Notified Body is an independent organization designated by the EU to evaluate product compliance.
Manufacturers must prepare a comprehensive Technical File, including but not limited to:
Device description and intended use
Risk management documentation
Performance and safety test data
Clinical evaluation reports
Labeling and instructions for use
Compliance with ISO 13485, the internationally recognized standard for medical device QMS, is required. This ensures consistent design, manufacturing, and post-market processes.
Manufacturers must demonstrate the safety and effectiveness of the device through clinical data. This may include:
Pre-clinical laboratory testing
Clinical trials or evaluations
Biocompatibility testing
Once the device successfully completes the conformity assessment and meets all requirements, the manufacturer may affix the CE mark to the product. The CE mark must be visible, legible, and placed on the device, packaging, and accompanying documentation.
Medical devices must be registered in the European Database on Medical Devices (EUDAMED) to ensure transparency and traceability.
Manufacturers must continuously monitor device performance through Post-Market Surveillance (PMS), periodically update technical documentation, and report incidents or adverse events through an established vigilance system.
KAS is continuing its efforts to become a Notified Body for Medical Device Certification.
If you are a manufacturer seeking certification for your medical device, you may contact our experts for consultancy and documentation support to ensure a smooth CE marking process.
Cihat DURĞAY:
📞 +90 505 261 7867
📧 medical@kascer.com