IVDR training series
This course consists of three half-day online modules providing a comprehensive understanding of the In Vitro Diagnostic Regulation (IVDR – EU 2017/746).
It covers the key requirements for CE marking, classification, technical documentation, performance evaluation, and post-market surveillance for IVD products.
The training aims to help participants understand regulatory expectations and prepare their organizations for IVDR compliance.
Course structure:
- Introduction to IVDR (746/2017) and CE-marking of In-Vitro Diagnostic devices – Nov 18, 2025
- Technical Documentation and risk classification, according to IVDR (746/2017) – Nov 27, 2025
- IVDR Performance Evaluation, Risk Management, incl Post-Market Surveillance and PMPF – Dec 9, 2025
Information
- When: to
- Where: Online
- Organizer: GBA Key2Compliance
- Language: English
- Price: 14 375 SEK VAT not included
Registration
Please register no later than Friday 7 November 2025
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Contact information
- GBA Key2Compliance
- +46 (0)8 621 05 02
- info@key2compliance.com
- https://key2compliance.com