Bioexcelife
Introduction: Understanding the New IVDR Regulation
The In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) has replaced the older In Vitro Diagnostic Directive (IVDD) (98/79/EC), introducing stricter regulatory requirements for in vitro diagnostic (IVD) medical devices in the European Union (EU).
With the IVDR full implementation deadline set for May 26, 2025, IVD manufacturers must comply with new risk-based classifications, performance evaluation requirements, and post-market surveillance obligations. Delaying compliance could result in product withdrawal from the EU market.
In this guide, we’ll explore key changes under #CROMedicalDevice IVDR, the challenges manufacturers face, and how to successfully transition to ensure continued market access.
Key Differences Between IVDR & IVDD
1. Risk-Based Classification System Under IVDR
One of the most significant changes in #CROMedicalDevice IVDR is the new risk-based classification system, which replaces the self-certification process under #CROMedicalDevice IVDD. Under IVDR, IVDs are classified into four risk-based categories:
| IVDR Classification | Example Devices | Notified Body Involvement |
| Class A (Low Risk) | Sample containers, laboratory equipment | No NB required (if non-sterile) |
| Class B (Moderate Risk) | Pregnancy tests, cholesterol tests | NB required |
| Class C (High Risk) | Companion diagnostics, genetic testing kits | NB required |
| Class D (Highest Risk) | HIV or Hepatitis screening tests, blood grouping tests | NB required with additional scrutiny |
2. Stricter Performance Evaluation Requirements
#CROMedicalDevice IVDR places greater emphasis on clinical evidence and performance evaluation, ensuring that all IVDs demonstrate scientific validity, analytical performance, and clinical performance.
Under IVDR, manufacturers must submit a Performance Evaluation Report (PER), which includes:
✔️ Scientific Validity: Demonstrates the relationship between the analyte and the clinical condition.
✔️ Analytical Performance: Assesses sensitivity, specificity, and accuracy of the device.
✔️ Clinical Performance: Measures how well the device performs in real-world clinical settings.
🚨 Key Challenge:
Retrospective literature reviews alone are no longer sufficient—manufacturers must conduct clinical performance studies for many IVDs.
3. Post-Market Surveillance (PMS) & Vigilance Requirements
IVDR strengthens post-market surveillance (PMS) and vigilance obligations, requiring continuous monitoring of device performance after market approval.
What IVDR Requires for PMS:
✅ Post-Market Performance Follow-Up (PMPF): Continuous collection of clinical data #CROMedicalDevice post-market.
✅ Periodic Safety Update Reports (PSUR): #CROMedicalDevice Regular safety updates for Class C & D devices.
✅ Faster Incident Reporting: Serious adverse events must be reported within a defined timeframe.
🚨 Key Challenge:
Manufacturers need robust data management systems to collect and analyze post-market data in compliance with #CROMedicalDevice IVDR.
4. Notified Body (NB) Involvement & Market Challenges
Unlike IVDD, where only 20% of IVDs required notified body approval, under IVDR, over 90% of IVD devices now need NB assessment. However, there are limited #CROMedicalDevice IVDR-designated notified bodies, causing approval bottlenecks.
🚨 Key Challenge:
- Companies must act fast to secure a notified body before the 2025 deadline.
- Delays in NB approvals could prevent market access for many IVD products.
Challenges IVD Manufacturers Face Under IVDR
1️⃣ Increased Regulatory Burden – More extensive documentation and clinical data requirements.
2️⃣ Limited Notified Body Capacity – Fewer IVDR-designated NBs mean longer approval timelines.
3️⃣ Higher Compliance Costs – Clinical studies, post-market surveillance, and regulatory approvals increase expenses.
4️⃣ Tight Transition Deadlines – The 2025 deadline is fast approaching, and many companies are still unprepared.
How Bioexcel Can Help You with IVDR Compliance
At Bioexcel, we provide end-to-end regulatory support to help IVD manufacturers navigate IVDR requirements.
Our IVDR Services Include:
✅ Performance Evaluation & Clinical Data Support
✅ Technical Documentation Preparation (GSPR, PER, PMS Plans)
✅ Notified Body Interaction & Submission Assistance
✅ Post-Market Surveillance & Risk Management Compliance
🚀 Partner with #Bioexcel to ensure your IVD device meets #CROMedicalDevice IVDR standards before the 2025 deadline!
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Conclusion: Why IVDR Compliance Needs Immediate Attention
The transition from #CROMedicalDevice IVDD to IVDR represents the most significant regulatory change for IVD devices in the EU.
💡 What IVD Manufacturers Should Do Now:
✔️ Assess device classification under IVDR
✔️ Strengthen clinical performance evaluation & data collectio
✔️ Prepare PMS & vigilance reports
✔️ Secure a notified body as early as possible
With the May 2025 IVDR deadline approaching, manufacturers who fail to comply will risk losing access to the EU market. Early planning and expert guidance are essential.
📩 Need help with #CROMedicalDevice IVDR compliance? Contact Bioexcel today to ensure your IVD device is fully compliant and ready for market approval!
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