As the field of in vitro diagnostic devices (IVDs) rapidly advances, regulatory compliance has become increasingly stringent. With the full implementation of the In Vitro Diagnostic Medical Device Regulation (EU) 2017/746 (IVDR) on May 26, 2022, manufacturers must adhere to new technical documentation requirements by transition deadline. These requirements, outlined in Annex II and Annex III of the IVDR, are essential for manufacturers aiming to achieve or maintain CE marking for IVDs in the European market. This blog provides an overview of the critical elements involved in preparing IVDR-compliant technical documentation and post-market surveillance requirements.
Key Components of IVDR Technical Documentation (Annex II)
All IVDs, regardless of classification or risk level, must include the following elements in their technical documentation as per Annex II of the IVDR:
Device Description and Specifications
Detailed description of the device, including its intended purpose, indications for use, and unique characteristics.
Information on variants, accessories, and key components that contribute to device performance.
Information Supplied by the Manufacturer
Instructions for Use (IFU) and Labels that provide users with clear, essential information on the safe use and maintenance of the device.
Compliance with labeling requirements as outlined in Annex I of the IVDR, ensuring consistency and clarity for users and healthcare professionals.
Design and Manufacturing Information
Detailed documentation of the device design and manufacturing processes.
Information on materials used, production methods, and quality controls applied during manufacturing.
General Safety and Performance Requirements (GSPRs)
Evidence that the device meets the GSPRs outlined in Annex I of the IVDR, covering safety, performance, and risk mitigation.
Risk management and performance evidence that aligns with harmonized standards and applicable guidance.
Benefit-Risk Analysis and Risk Management
Comprehensive benefit-risk analysis demonstrating that the benefits of the device outweigh potential risks.
Documentation of risk management activities conducted throughout the device lifecycle, including regular updates as required by Annex I, Section 3 of the IVDR.
Product Verification and Validation
Analytical Performance: Evidence supporting the analytical validity of the device.
Clinical Performance: Data demonstrating clinical validity, particularly for devices with a direct therapeutic impact.
Scientific Validity: Supporting evidence for the scientific principles behind the device.
Stability: Data on device stability, including storage and shelf-life information.
Usability: Evidence confirming that the device can be used safely and effectively by the intended user.
Device Lifetime: Information on expected device lifecycle and any degradation factors.
Additional Information for Specific Cases
Documentation for devices requiring additional validation, such as those involving sterilization, specific packaging requirements, or reusable components.
Post-Market Surveillance (PMS) and Vigilance (Annex III)
Annex III of the IVDR outlines the requirements for Post-Market Surveillance (PMS) to ensure continuous compliance and safety monitoring of IVDs once they are on the market. Key components include:
Post-Market Surveillance (PMS) Plan
A structured PMS plan that outlines the methods for gathering, assessing, and analyzing post-market data, including feedback from users, reports on incidents, and scientific literature.
Post-Market Performance Follow-Up (PMPF)
The PMPF plan is an essential part of the PMS system, detailing the ongoing collection of clinical and performance data.
PMPF activities should be conducted in line with the device’s risk classification and identified safety concerns.
PMS Reports (PMSR) for Class A and B Devices
Manufacturers of Class A and B devices must compile a PMS Report (PMSR) based on data collected from the market.
PMSR should be reviewed periodically to assess the safety and performance of the device.
Periodic Safety Update Report (PSUR) for Class C and D Devices
Manufacturers of Class C and D devices must prepare a PSUR for each device, updated annually.
PSURs should include cumulative information on safety, effectiveness, and any risk-benefit considerations over the device's lifecycle.
Class C and D PSURs must be submitted to the notified body as part of the technical documentation submission and upon request in subsequent years.
Vigilance System
A vigilance system must be in place to capture, assess, and report adverse incidents.
The system should be capable of identifying potential corrective or preventive actions based on data collected from serious incidents, complaints, and other sources.
Performance Evaluation Report (PER) Requirements (Annex XIII)
As per Annex XIII, a Performance Evaluation Report (PER)Â must accompany the technical documentation. This report should include:
Scientific Validity: Demonstrates that the analyte or marker measured by the device is associated with a clinical condition.
Analytical Performance: Evidence that the device accurately measures the intended analyte or marker under specified conditions.
Clinical Performance: Data confirming that the device performs as intended in clinical settings, supporting diagnostic or therapeutic decisions.
Additional Key Considerations for IVDR Compliance
Continuous Risk Management: Risk management is a continuous process throughout the entire lifecycle of the device, as emphasized in IVDR Annex I, Section 3. Manufacturers must regularly review and update risk assessments based on new data and market feedback.
Utilize Harmonized Standards: Manufacturers should align their technical documentation with European Harmonized Standards to meet regulatory expectations efficiently.
Consult Experienced CE-Marking Specialists: Due to the complexity of IVDR requirements, manufacturers may benefit from working with CE-marking consultants who have extensive experience in regulatory submissions for IVDs.
Timely Preparation and Updates: IVDR compliance is required for all IVDs seeking CE certification. Preparing technical documentation early and updating it regularly is essential for continued compliance.
How OneGlobal Trinity M Consulting Can Help with IVDR Technical Documentation Submissions
Navigating the complexities of the IVDR can be challenging, especially with the rigorous requirements for technical documentation, post-market surveillance, and performance evaluation. OneGlobal Trinity M Consulting is here to support IVD manufacturers in meeting these requirements effectively and efficiently. Our team of experienced consultants provides tailored solutions for each stage of IVDR compliance, from initial documentation development to final submission. With our deep expertise in regulatory strategy, we can help you:
Develop and Review Technical Documentation: We ensure that your documentation meets all IVDR Annex II requirements, including device descriptions, design information, GSPRs, and performance validation.
Establish a Comprehensive Post-Market Surveillance Plan: We guide you in setting up robust PMS systems, including PMPF, PMSR, and PSUR reports, to maintain compliance after market entry.
Conduct a Thorough Performance Evaluation: Our team assists in compiling the Performance Evaluation Report (PER) required under Annex XIII, ensuring that your device’s scientific and clinical validity are well-documented.
Streamline Your Submission Process: From preparing the initial application to navigating notified body reviews, we manage the process end-to-end, helping you achieve timely and successful CE marking under IVDR.
Conclusion
The IVDR represents a significant shift in the regulatory landscape for IVDs, with comprehensive requirements for technical documentation, post-market surveillance, and performance evaluation. Meeting these requirements is essential for ensuring the safety and effectiveness of IVDs in the European market. By adhering to IVDR Annex II and III requirements, manufacturers can demonstrate that their devices meet the EU’s stringent standards, facilitating a smoother regulatory pathway and helping to bring innovative diagnostic solutions to patients across Europe.
Partnering with OneGlobal Trinity M Consulting allows you to approach IVDR compliance with confidence, knowing you have expert support to help you meet regulatory expectations and bring your diagnostic solutions to market. Let us simplify your IVDR journey—contact us today to discuss how we can assist with your technical documentation and regulatory submissions.
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