Obtaining a CE mark IVD devices

EU-IVDR CE MARKING

CE mark IVD compliance

If you are manufacturing or distributing In Vitro Diagnostic (IVD) devices in the European Union, obtaining a CE mark IVD is essential to demonstrate compliance with the IVDR (2017/746). The EU-IVDR is the regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It replaced the EU in vitro diagnostic directive (98/79/EC) in May 2022. The IVD regulation covers devices sold as individual devices or kits as well as those provided as a testing service under distance sales requirements or the in-house exemption. 

Obtaining a CE mark for IVD devices is a complex process that requires careful planning, documentation, and adherence to regulatory requirements. Our consultants and IVD experts have many years of navigating these processes effectively based on industry and Notified Body experience. 

1. Classification: Determine your IVD device's classification according to the EU's IVD Directive or In Vitro Diagnostic Regulation (IVDR). Classification rules depend on factors like intended purpose, risk, and stability.
   
   
2. Quality Management System: Implement and maintain a Quality Management System (QMS) in accordance with relevant standards (e.g., ISO 13485) to ensure consistent quality throughout the device lifecycle.
   
   
3. Design and Development: Conduct design and development activities following applicable standards and guidelines. Perform risk management and validation studies to ensure safety and performance. Freeze the design before starting analytical or clinical performance studies.
   
   
4. Clinical Evaluation: Generate clinical data according to Annex XIII and XIV. Clinical data is expected for all Class B, C, and D devices. This can be generated from a clinical performance study (CPS) conducted in Europe, as well as literature reviews and post-market surveillance data on the same device. 
   
   
5. Technical File Preparation: Prepare technical documentation demonstrating conformity with general safety and performance requirements (GSPR) outlined in the regulation. This includes design specifications, risk assessment, clinical data, and labeling information. 
   
   
6. Conformity Assessment: Conformity Assessment: Devices in Class A sterile, B, C, and D must apply to a Notified Body for a conformity assessment review. The Notified Body will audit the quality management system QMS) and perform a remote review of the technical file by an expert. Class D devices must meet the appropriate Common Specification, and the device must be tested to the CS by a European Reference Laboratory where they are available. Companion Diagnostic (CDx) devices must have a review with EMA in addition to the Notified Body review.
   
   
7. Declaration of Conformity: Prepare a Declaration of Conformity according to Annex IV, declaring that your IVD device complies with applicable directives or regulations. The DoC must not be signed until after the Notified Bodies conformity assessment is complete and the certificate has been issued.
   
   
8. Authorized representative: manufacturers outside Europe require an authorized representative in the EU.
   
   
9. Person Responsible for Regulatory Compliance (PRRC): Each manufacturer and authorized representative must have a qualified PRRC to ensure that the technical documentation is prepared and maintained and to oversee clinical studies' compliance with regulatory requirements.
   
   
10. EUDAMED: Devices must be registered in EUDAMED. If EUDAMED is not available, national requirements may apply.
    
    
11. CE Marking: Affix the CE mark on your IVD device once you have completed all necessary steps and have obtained a positive assessment from a Notified Body (if required).
    
    
12. Post-Market Surveillance: Establish proactive and reactive procedures for monitoring the performance and safety of your IVD device on the market. Reactive procedures include reporting any adverse events to relevant authorities.
    
    
13. Renewal and Updates: Notified Bodies are required to sample Class B+C devices every year, so it is essential to keep your Technical File updated and ensure ongoing compliance with changes to standards and guidance and that significant changes to products are submitted to the Notified Body for approval. CE certificates must be renewed every 5 years. Class D devices will require the release of each batch by the Notified Body and testing by a European Reference Laboratory.