We invite you to participate in a full-day course (limited seats, paid registration) designed for the Brightlands MedTech Community, offering a detailed and practical exploration of the European In Vitro Diagnostic Regulation (IVDR).
The course is designed to answer the central question:
"How can I bring my IVD product to market as quickly and efficiently as possible, while meeting all regulatory requirements?"
- Time: 09.00 - 17.00
- Language: English
- Duration: 1 full day (approx. 8 hours)
- Maximum Participants: 25 (limited seats – early registration recommended)
- Course Fee: €250 per participant (incl. refreshments and lunch)
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Course Objective:
This intensive training day provides a comprehensive and practical overview of the European regulatory framework for in vitro diagnostics (IVDR), with a focus on the required steps to gain IVDR-market access.
Program Overview
Participants will gain actionable insights into the IVDR and learn how to strategically navigate the regulatory pathway from product development to market access.
1. Positioning the IVDR within the EU Regulatory Landscape
- Introduction to the IVDR and its replacement of the IVDD
- Comparison between IVDR and MDR: key differences and overlaps
- Which types of products fall under the scope of IVDR?
- Connections to other EU regulations and relevant ISO/IEC standards
2. IVDR vs. International Market Requirements for the regulatory pathways for IVDs in
- Canada
- United States
- Rest of the World (RoW) – general considerations
3. Regulatory Strategy as a Core Business Component
Learn how to integrate regulatory planning into your business strategy to accelerate market entry and optimize resources.
Topics include:
- Defining intended purpose and product claims
- Risk classification of IVDs
- Quality Management System (QMS) requirements and certification
- Role of Notified Bodies – when are they needed?
- Product specifications & labeling requirements
- Performance Evaluation Plan (PEP) & Performance Evaluation Report (PER)
- Technical documentation – preparing for market application
- Post-market readiness: surveillance, complaints, vigilance, and recalls
4. Performance Evaluation Throughout the Product Lifecycle:
A deep dive into performance evaluation, covering:
- State-of-the-Art and scientific validity in relation to risk
- Testing requirements and validation strategies
- Post-market performance follow-up (PMPF)
Interactive Component
Participants are invited to submit a case-related question in advance. Selected cases will be discussed interactively during the course, allowing for practical application of the concepts covered.