Understanding CE Certification for Medical Devices and IVDs Under EU MDR & IVDR
Medical devices and In Vitro Diagnostic Devices (IVDs) intended for the European market must comply with strict regulatory requirements under the European Medical Device Regulation (EU MDR 2017/745) and In Vitro Diagnostic Regulation (EU IVDR 2017/746). CE marking demonstrates that a product meets the applicable safety, performance, and regulatory requirements necessary for commercialization within the European Union.
Manufacturers often require regulatory guidance to understand applicable requirements, prepare technical documentation, coordinate with notified bodies, and complete conformity assessment procedures successfully.
What Is CE Certification for Medical Devices?
CE certification is a regulatory conformity process that confirms a medical device or IVD complies with European regulatory requirements. Depending on the classification and intended purpose of the device, manufacturers may need involvement from a notified body before placing the product on the European market.
The CE marking process generally includes:
Device classification
Identification of applicable standards
Preparation of technical documentation
Risk management documentation
Clinical or performance evaluation
Post market surveillance documentation
Declaration of conformity
Notified body assessment, where applicable
Technical Documentation Requirements Under EU MDR and IVDR
Under Annex II and Annex III of EU MDR and IVDR, manufacturers are required to maintain detailed technical documentation demonstrating product safety and performance.
Technical documentation may include:
General Safety and Performance Requirements (GSPR)
Risk management files
Clinical evaluation reports
Performance evaluation documentation
Usability engineering documentation
Software validation documentation
Biological evaluation
Labeling and IFU review
Verification and validation reports
Post Market Surveillance (PMS) documentation
The documentation requirements vary depending on the device classification, intended purpose, and applicable conformity assessment route.
CE Certification for Software as a Medical Device (SaMD)
Software intended for medical purposes may qualify as Software as a Medical Device (SaMD) under EU MDR 2017/745. Manufacturers developing medical software applications must ensure compliance with applicable regulatory and software lifecycle requirements before obtaining CE marking.
Regulatory activities for SaMD may include:
Software classification
Cybersecurity considerations
Software lifecycle documentation
Clinical evaluation
Usability engineering
Risk management
Validation and verification activities
Compliance with standards such as IEC 62304, IEC 82304-1, IEC 62366, and ISO 14971 is commonly required during the conformity assessment process.
Post Market Surveillance (PMS) Requirements
EU MDR and IVDR require manufacturers to establish a systematic Post Market Surveillance (PMS) process to continuously monitor product safety and performance after market placement.
PMS documentation may include:
PMS Plan
PMS Report
Periodic Safety Update Report (PSUR)
Post Market Clinical Follow-up (PMCF) documentation for medical devices
Post Market Performance Follow-up (PMPF) documentation for IVDs
The scope and frequency of PMS activities depend on the device classification and associated risks.
Clinical Evaluation for Medical Devices
Clinical evaluation is a mandatory requirement under EU MDR and is used to demonstrate the safety and clinical performance of a medical device.
Clinical evaluation activities generally involve:
Clinical Evaluation Plan (CEP)
Literature search protocol
Literature review and appraisal
Clinical Evaluation Report (CER)
Assessment of clinical data and equivalence
Manufacturers must ensure that the clinical evidence adequately supports the intended purpose and claims associated with the device.
Performance Evaluation for In Vitro Diagnostic Devices
Under EU IVDR, IVD manufacturers are required to conduct performance evaluations demonstrating scientific validity, analytical performance, and clinical performance.
Performance evaluation documentation may include:
Performance Evaluation Plan (PEP)
Scientific validity reports
Analytical performance reports
Clinical performance reports
Performance Evaluation Report (PER)
These documents form an important part of the technical documentation reviewed during conformity assessment.
Role of the European Authorized Representative (EAR)
Manufacturers located outside the European Union are required to appoint a European Authorized Representative (EAR) when placing products on the EU market.
The EAR acts as the manufacturer’s authorized regulatory representative within Europe and supports communication with competent authorities and notified bodies in accordance with EU MDR and EU IVDR requirements.
Importance of Regulatory and Technical Documentation Support
Preparing EU MDR and IVDR documentation requires understanding of evolving regulations, harmonized standards, guidance documents, and notified body expectations.
Regulatory support may help manufacturers with:
Identification of applicable regulatory pathways
Technical documentation preparation
Gap assessment
Compliance strategy
Audit preparation
Resolution of notified body observations
Ongoing regulatory maintenance activities
Proper documentation planning and regulatory coordination can help streamline the conformity assessment process and reduce delays during certification activities.
Key Considerations Before Starting CE Marking
Manufacturers planning CE certification should consider:
Device classification accuracy
Applicable harmonized standards
Clinical or performance evidence requirements
PMS obligations
Software validation requirements
Notified body availability and timelines
Regulatory updates under EU MDR and IVDR
Early regulatory planning helps improve documentation quality and supports smoother certification processes.