IVDR - From Fundamentals to Technical Documentation – Get Ready for Certification

The EU IVDR Regulation has significantly changed the requirements for in vitro diagnostic (IVD) medical devices. IVDR (EU 2017/746) replaces the former IVDD Directive and sets considerably stricter requirements for safety, performance, and documentation.

The transition from IVDD to IVDR has presented significant challenges for many organizations, particularly in the areas of technical documentation, clinical evidence, and risk management. The topic is equally important for manufacturers of new devices, as devices must comply with IVDR requirements before being placed on the market.

In addition, the majority of IVD devices are now subject to assessment by a Notified Body, adding a further layer to the conformity assessment process for IVD devices.

This training provides a clear and practical approach to understanding and implementing IVDR requirements within your organization. The course also explains the role of the Notified Body and its processes in IVDR conformity assessment.
The training is conducted in English. 

Date and Time: 

11 November 2026,  at 10-16 (UTC +2, Helsinki time), Online via Microsoft Teams

The training fee is €595 per participant. Students are entitled to a 50% discount, and participants from Healthtech Finland member companies receive a €50 discount off the regular price. If you qualify for either discount, please mention it in the "Additional Information" section of the registration form when signing up for the course. VAT will be added in accordance with the applicable rate.

Please register at the latest November 2nd, 2026