Legal requirements of the EU regulation for in-vitro diagnostics
Since May 25, 2017, the new IVD Regulation has been in force.
In our IVDR basic course, you will learn step by step which requirements you need to consider in order to bring your products to market. Each step is explained clearly and with many practical examples.
The seminar contents
- Differences from the IVDD / Classification
- Technical Documentation / Quality Management Requirements
- Performance and safety requirements (formerly: essential requirements)
- Conformity assessment
- Clinical evaluation / Performance studies (formerly: performance evaluation test)
- The role of notified bodies in the approval process
- Re-certification of existing products / The path to CE marking
- Post-Market Surveillance / Timelines to be observed, transitional provisions and deadlines
Costs
1-day in-house training: €3,890 (excl. VAT) for up to 10 participants
Includes seminar materials and certificate of participation; travel expenses additional
Your trainer
Mag. Marie Salin, Managing Director, West Medica Produktions- und Handels-GmbH – experienced regulatory expert for IVD, consultant, trainer, and certified internal auditor
Book now:
Please send your request to seminare@encotec.at or call us: +43 1 8863491 +43 1 8863491
