In Vitro Diagnostic Regulation: Expert Guide to EU 2017/746

The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 establishes a comprehensive framework governing in vitro diagnostic medical devices throughout the European Union. This pivotal legislation significantly enhances patient safety, market surveillance, and transparency while introducing new classification systems and stricter requirements for manufacturers seeking EU market access.

 

What is the In Vitro Diagnostic Regulation?

 

 

The IVDR entered into force on May 26, 2017, replacing the previous In Vitro Diagnostic Medical Devices Directive (IVDD 98/79/EC). This regulation represents a fundamental shift in how in vitro diagnostic medical devices (IVDs) are regulated across the European market.

IVDs are tests used on biological samples from the human body that provide information about physiological states, pathological processes, congenital abnormalities, compatibility determinations, treatment response predictions, and therapeutic monitoring.

The IVDR aims to:

• Strengthen patient safety through more robust clinical evidence requirements
• Improve transparency via comprehensive labeling and the EUDAMED database
• Enhance post-market surveillance and vigilance systems
• Harmonize requirements across EU Member States
• Establish clearer responsibilities throughout the supply chain

 

Key Changes Under the IVDR

 

New Risk-Based Classification System

The IVDR introduces a four-class risk-based classification system, replacing the previous list-based approach:

• Class A: Low individual and public health risk (e.g., specimen receptacles)
• Class B: Moderate individual risk and/or low public health risk
• Class C: High individual risk and/or moderate public health risk (e.g., cancer screening tests)
• Class D: High individual and public health risk (e.g., HIV tests, blood screening)

This system has dramatically expanded the scope of devices requiring notified body involvement—from approximately 20% under the IVDD to 80-90% under the IVDR.

 

Enhanced Clinical Evidence Requirements

The IVDR emphasizes stronger clinical evidence and performance evaluation, requiring manufacturers to:

• Demonstrate scientific validity
• Provide analytical performance data
• Submit clinical performance evidence
• Implement ongoing performance evaluation
• Conduct post-market performance follow-up (PMPF)

These requirements represent a substantial change from the IVDD and necessitate more comprehensive data collection throughout the device lifecycle.

 

Unique Device Identification and EUDAMED

Each IVD must now carry a Unique Device Identification (UDI) to improve traceability. Additionally, the European Database on Medical Devices (EUDAMED) serves as a central platform for information exchange between stakeholders, including data on:

• Device registration
• Certificates
• Performance studies
• Post-market surveillance
• Vigilance reporting
• Market surveillance

The European Commission's EUDAMED website offers comprehensive resources for manufacturers navigating these new requirements.

 

Strengthened Post-Market Surveillance

Manufacturers must establish systematic procedures to collect and review experience from their devices post-market, including:

• Post-market surveillance plans
• Post-market surveillance reports (Class A and B devices)
• Periodic safety update reports (Class C and D devices)
• Trend reporting of non-serious incidents

This approach aligns with the broader EU regulatory framework, including the EU AI Act, which similarly emphasizes ongoing monitoring and risk management.

 

IVDR Implementation Timeline

The IVDR entered into full application on May 26, 2022, with phased transition periods:

• Class D devices: Until May 26, 2025
• Class C devices: Until May 26, 2026
• Class B and Class A sterile devices: Until May 26, 2027

According to the World Health Organization's guidance on medical device regulations, these staggered deadlines acknowledge the significant challenges manufacturers face in meeting the enhanced requirements.

 

Steps to IVDR Compliance

 

1. Device Classification

Determine your IVD's risk class according to Annex VIII of the IVDR, as this dictates the conformity assessment route required.

 

2. Technical Documentation

Compile comprehensive technical documentation including:

• Device description and specifications
• Information supplied to users
• Design and manufacturing details
• Safety and performance evidence
• Benefit-risk analysis
• Verification and validation data

 

3. Quality Management System Implementation

Establish a QMS compliant with IVDR Article 10(8), covering:

• Regulatory compliance strategy
• Product realization processes
• Risk management
• Performance evaluation
• Post-market surveillance

 

4. Conformity Assessment

Follow the appropriate conformity assessment procedure based on the device's risk class:

• Class A: Self-assessment (except for sterile devices)
• Class B, C, and D: Notified body assessment with varying scrutiny levels
• Class D: Additional EU reference laboratory scrutiny

 

5. Post-Market Surveillance System

Implement an effective post-market surveillance system that actively collects data, identifies necessary actions, reports incidents, and updates technical documentation.

 

6. EU Declaration of Conformity and CE Marking

After successful conformity assessment, draw up an EU declaration of conformity and affix the CE marking to obtain market access.

 

Impact on Stakeholders

 

For Manufacturers

The IVDR presents both challenges and opportunities:

• Increased compliance costs
• Resource-intensive clinical evidence gathering
• Strategic portfolio decisions
• Competitive advantage through enhanced quality standards

Many manufacturers are reviewing their global AI regulations compliance strategies alongside IVDR preparations, as these regulatory frameworks increasingly intersect.

 

For Healthcare Providers and Laboratories

Healthcare professionals and laboratories face several considerations:

• Potential temporary product shortages during transition
• Changes in laboratory-developed tests (LDTs) regulation
• Access to more reliable diagnostic tools with improved performance data

 

For Patients

The IVDR ultimately benefits patients through:

• Enhanced safety of IVDs
• Improved diagnostic accuracy
• Greater transparency
• Faster identification of safety issues

 

Common Challenges in IVDR Implementation

 

 

Several significant challenges have emerged during implementation:

• Limited notified body capacity: Few designated bodies with increased assessment demands
• Technical documentation overhauls: More stringent requirements for existing documentation
• Performance evaluation complexity: More demanding evidence standards
• Supply chain coordination: New responsibilities for all economic operators

The Medical Device Coordination Group guidance documents provide valuable resources for addressing these challenges.

 

Expert IVDR Compliance Support

Navigating the IVDR landscape requires specialized expertise. At Nemko, our AI regulatory compliance services team offers comprehensive support throughout your compliance journey:

• Gap analysis against IVDR requirements
• Strategic guidance on classification and conformity assessment
• QMS development assistance
• Performance evaluation support
• Post-market surveillance system design
• Notified body audit preparation

Our experts maintain deep knowledge of both IVDR and EU harmonized standards, ensuring you receive the most current guidance.

 

IVDR Implementation Roadmap

The In Vitro Diagnostic Regulation represents a fundamental shift in IVD regulation across the European market. Successfully navigating this complex landscape requires:

• Understanding the risk-based classification system
• Proactively gathering clinical evidence
• Implementing robust quality and surveillance systems
• Strategic transition planning
• Partnering with experienced regulatory experts

Ready to ensure your in vitro diagnostic devices meet IVDR requirements? Contact Nemko today to discuss your compliance needs and discover how our expert team can support your journey to IVDR compliance with tailored solutions that maintain market access while enhancing product safety and performance.

Request a consultation today to begin your IVDR compliance journey with confidence.