In-Vitro Diagnostic Consultancy: Navigating IVDR Compliance
Expert guidance on IVDR compliance, classification rules, and performance evaluation for in-vitro diagnostic devices. Learn how professional consultancy can streamline your path to market.
The EU In Vitro Diagnostic Regulation (IVDR) 2017/746 is the regulatory framework governing in vitro diagnostic medical devices placed on the EU market. It replaced the IVD Directive (98/79/EC) and introduced a stricter risk-based classification system with four classes (A, B, C, D), mandatory Notified Body involvement for most devices, and enhanced performance evaluation requirements including scientific validity, analytical performance, and clinical performance evidence.
The IVDR Challenge
The transition to IVDR brings significant changes:
- New risk-based classification system
- Enhanced requirements for clinical evidence
- Stricter oversight of high-risk devices
- More detailed technical documentation
- Increased post-market surveillance
Key Areas of Support
Professional IVD consultancy services are crucial for:
- Device Classification
- Determining risk class under IVDR
- Understanding specific requirements
- Planning compliance strategy
- Performance Evaluation
- Scientific validity studies
- Analytical performance assessment
- Clinical performance evidence
- Post-market follow-up planning
- Quality Management
- ISO 13485 implementation
- Risk management systems
- Technical documentation
- Post-market surveillance
Expert Guidance at Advena Medical
At Advena Medical, we provide comprehensive IVDR consultancy services:
- Strategic regulatory planning
- Classification support
- Performance evaluation guidance
- Technical documentation review
- Post-market surveillance planning
- Notified Body liaison
Getting Started
Ready to ensure your IVD devices meet all IVDR requirements? Visit our IVD consultancy services page to learn how we can support your compliance journey.
Frequently Asked Questions
What is the difference between the IVDR and the old IVD Directive?
The IVDR introduces a risk-based classification system with four classes (A–D), replacing the self-declaration approach used for most devices under the old Directive. The vast majority of IVDs that were previously self-certified now require Notified Body involvement, and performance evaluation requirements are significantly more demanding.
When did the IVDR come into full effect?
The IVDR became fully applicable on 26 May 2022, though transitional arrangements allow devices with valid IVDD certificates to continue on the market until 2025, 2026, or 2027 depending on their class, provided certain conditions are met.
Does my IVD device need a Notified Body under IVDR?
It depends on the classification. Class A non-sterile devices can be self-certified. Class A sterile and Class B devices require Notified Body involvement in quality system assessment. Class C and D devices require full technical documentation review by a Notified Body, with Class D devices also requiring a reference laboratory consultation.
What is a Performance Evaluation Report (PER) under IVDR?
A Performance Evaluation Report is the core document demonstrating that an IVD device achieves its intended performance — covering scientific validity, analytical performance, and clinical performance. It must be based on a defined performance evaluation plan and updated continuously as part of post-market follow-up.