If you work with in vitro diagnostic (IVD) devices, you’re likely aware of the changes introduced by the In Vitro Diagnostic Medical Device Regulation (IVDR). This regulation, effective since May 26, 2022, has brought stricter requirements to ensure the safety, accuracy, and reliability of IVD devices across the European Union.

Let’s face it—complying with the IVDR can feel overwhelming. New risk classifications, performance evaluations, post-market surveillance… it’s a lot to manage! But don’t worry—you’ve come to the right place.

In this article, you’ll learn:

  • What IVDR compliance means for managing performance data.
  • How ISO 20916 serves as your guide for clinical performance studies.
  • Why a validated EDC system can be your best ally to save time and avoid complications.

Let’s dive in because there’s a lot to uncover (and simplify).

What Does the IVDR Require?

The IVDR replaces the previous Directive 98/79/EC with a more rigorous and structured approach for IVD devices. But what does this mean for you?

In simple terms, the IVDR requires all IVD devices to be backed by solid performance data. This data proves that your device:

  1. Delivers precise and reliable analytical results.
  2. Provides clear clinical value for its intended purpose.
  3. Meets strict safety and quality standards.

Whether it’s a pregnancy test or a high-complexity diagnostic device for infectious diseases, you need clear and documented evidence to demonstrate that your product is safe and effective.

When Do You Need a Clinical Performance Study?

Not all IVD devices require a clinical performance study, but it is necessary in the following key scenarios:

  • High-risk devices (Classes C and D): Such as tests for HIV, hepatitis, or blood screening.
  • Innovative or new devices: Without sufficient existing data to support their performance.
  • Changes to indications for use: When the device is used for new purposes not previously validated.
  • Lack of equivalence: If you cannot justify technical and clinical equivalence with another approved device.

If your device falls into one of these categories, you’ll need to conduct a study in line with ISO 20916, ensuring quality and safety.

Managing Performance Data Under the IVDR: What’s Changed?

The IVDR introduces significant changes, especially for performance evaluation. Here are the key points you need to know:

1. Risk-Based Classification

IVD devices are now classified into four risk classes: A, B, C, and D. The higher the risk, the stricter the regulatory scrutiny:

  • Class A: Low risk (e.g., general culture media).
  • Class B: Moderate risk (e.g., pregnancy tests).
  • Class C: High risk (e.g., tests for hepatitis or serious infections).
  • Class D: Very high risk (e.g., HIV blood screening tests).

Devices in Classes B, C, and D require evaluation by a notified body, which includes a thorough review of performance data.

2. Three Pillars of Performance Evaluation

Performance evaluation under the IVDR is based on three types of data:

  1. Analytical performance: Does your device measure what it claims to measure?
  2. Clinical performance: Are the results useful and reliable in a clinical setting?
  3. Scientific validity: Is there proven evidence linking what your device measures to the clinical condition it assesses?

This information must be documented in a Performance Evaluation Report (PER), which will be reviewed by the notified bodies.

3. Post-Market Surveillance (PMS)

Even after obtaining CE marking, your work isn’t done. The IVDR requires a Post-Market Performance Follow-Up (PMPF) plan to ensure your device continues to perform as expected.

Why Must IT Systems Be Validated?

While the IVDR doesn’t explicitly mention standards like ISO 20916 or validation requirements, its general provisions clearly imply that systems managing clinical data must ensure:

  • Accuracy: Data must be correct and free from errors.
  • Integrity: Data cannot be altered or deleted without proper traceability.
  • Traceability: All data and changes must be auditable.

Additionally, internationally recognized standards like 21 CFR Part 11 and Annex 11 require IT systems used in clinical studies to be validated. This ensures they function as intended and meet the highest quality standards. Any system, such as an EDC, must be validated to comply with these expectations and ensure data reliability and security.

How Can ShareCRF Help?

At ShareCRF, we understand the challenges of regulatory compliance. That’s why we’ve developed a validated EDC system designed to simplify performance data management and help you efficiently comply with the IVDR.

Benefits of ShareCRF for IVDR Compliance

  1. Guaranteed Compliance:
    Our system meets ISO 20916, GCP, and 21 CFR Part 11 requirements, ensuring data validation and traceability.
  2. Real-Time Monitoring:
    Easily track and resolve performance issues during your study.
  3. Complete Traceability:
    Record every entry, modification, and access, creating a solid audit trail.
  4. User-Friendly Design:
    Simplify data capture and management, no matter the size or complexity of your study.
  5. Scalable Solutions:
    Whether it’s a small pilot study or a large multicenter trial, ShareCRF adapts to your needs.

With ShareCRF, managing your performance data becomes not only simpler but also more reliable.

Ready to Simplify Your Path to IVDR Compliance?

Navigating the IVDR doesn’t have to be complicated. With ShareCRF, you can manage your performance data efficiently, securely, and in full alignment with international regulations.

Curious to see how it works? Request a free demo and discover how ShareCRF can turn regulatory compliance into a clear and manageable process.