Overview of CE Marking for Medical Devices
CE Marking for Class I, II, and III medical devices is a mandatory regulatory requirement for placing medical devices on the European market. It signifies that the device complies with the EU Medical Device Regulation (MDR 2017/745), ensuring safety, performance, and quality. Every manufacturer seeking to sell in the European Economic Area (EEA) must understand how classification affects conformity assessment, documentation, and regulatory pathways.
This guide explains the requirements and compliance process for CE Marking based on device classes and provides insights for manufacturers aiming for smooth approval.
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What Does CE Marking Mean for Medical Device Manufacturers?
CE Marking stands for “Conformité Européenne,” meaning European Conformity. It indicates that a medical device meets all essential safety and performance requirements under MDR 2017/745.
Without CE Marking, a device cannot be marketed or distributed legally within the EU.
The marking assures patients, healthcare professionals, and authorities that the product is:
- Safe for its intended use
- Manufactured under a certified quality system
- Supported by appropriate clinical evidence
- Continuously monitored post-market
Classification of Medical Devices under MDR
Medical devices are classified into Class I, IIa, IIb, and III depending on the risk level, intended use, and contact duration with the human body. The higher the class, the more stringent the conformity assessment.
| Device Class | Risk Level | Examples |
|---|---|---|
| Class I | Low risk | Stethoscopes, bandages, reusable surgical instruments |
| Class IIa | Medium risk | Infusion pumps, dental materials, hearing aids |
| Class IIb | Higher medium risk | Ventilators, anesthesia machines |
| Class III | High risk | Pacemakers, heart valves, implantable devices |
Understanding this classification is crucial because CE Marking requirements vary for each class.
CE Marking Requirements for Class I Medical Devices
Class I medical devices are self-certified, meaning the manufacturer can issue a Declaration of Conformity without the involvement of a Notified Body — provided the device is non-sterile and has no measuring function.
Requirements include:
- Implementation of a Quality Management System (QMS) compliant with ISO 13485
- Preparation of Technical Documentation under Annex II of MDR
- Conducting a risk assessment and clinical evaluation
- Issuing a Declaration of Conformity (DoC)
- Affixing the CE mark before placing the product on the market
For Class I sterile (Is) or measuring (Im) devices, a Notified Body must verify sterility or measurement functions.
CE Marking Requirements for Class II Medical Devices (IIa and IIb)
Class II devices require Notified Body involvement. The manufacturer cannot self-declare conformity.
Requirements include:
- Full Quality Management System audit by a Notified Body
- Technical File submission including design, risk management, and test reports
- Clinical evaluation and performance data review
- Verification of manufacturing process and product testing
- Continuous Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR)
For Class IIa, sampling may be performed; for Class IIb, full design documentation is reviewed before certification.
CE Marking Requirements for Class III Medical Devices
Class III devices are the highest-risk category, typically life-supporting or implantable devices. They require the most rigorous assessment under MDR.
Requirements include:
- Comprehensive design dossier review by a Notified Body
- Clinical investigations and robust clinical evaluation to demonstrate safety and performance
- QMS audit and facility inspection
- Pre-market and post-market clinical follow-up (PMCF) plan
- EU Type Examination Certificate issued before CE Marking
The manufacturer must demonstrate scientific validity, technical performance, and clinical evidence in compliance with Annex IX of MDR.
Common Steps for CE Marking for Class I, II, and III Devices
Regardless of class, the general process includes:
- Determine device classification under MDR.
- Identify applicable conformity assessment route.
- Implement EN ISO 13485-compliant QMS.
- Prepare technical documentation (Annex II and III).
- Conduct clinical evaluation and risk management.
- Engage a Notified Body (if required).
- Issue Declaration of Conformity.
- Affix CE marking and register the device in EUDAMED
Post-Market Responsibilities
Manufacturers must establish a Post-Market Surveillance (PMS) system to collect and analyze real-world data.
They must also:
- Maintain traceability and UDI (Unique Device Identification)
- Report serious incidents through the vigilance system
- Conduct periodic audits and product re-evaluations
Continuous compliance ensures the CE Mark remains valid throughout the product lifecycle.
How Operon Strategist Helps?
At Operon Strategist, we specialize in guiding medical device manufacturers through the CE Marking process for Class I, II, and III medical devices.
Our services include:
- Device classification and regulatory pathway assessment
- Technical documentation preparation
- Clinical evaluation and validation support
- Notified Body coordination and audit readiness
- Post-market compliance documentation
With years of regulatory experience, we help clients achieve faster CE certification and maintain long-term compliance across the European market.
Achieve CE Marking Faster with Complete Documentation and Compliance Support
FAQ'S
CE marking shows that a medical device meets EU MDR safety and performance requirements for sale in the European market.
Devices are divided into Class I, Class IIa, Class IIb, and Class III based on their risk level, with Class III being the highest-risk category.
No. Only Class IIa, IIb, and III devices need Notified Body involvement. Class I devices generally require self-certification unless sterile or measuring.
A Technical File, Declaration of Conformity, Quality Management System (ISO 13485), and clinical evaluation report are required.
