New EU regulations have placed much tougher requirements on the manufacturers of in vitro diagnostic devices. One of the new requirements under the In Vitro Diagnostics Regulation (EU) 2017/746 of the European Parliament and of the Council (IVDR) is that manufacturers create, compile, and maintain Technical Documentation as described in Annex II and Annex III of the Regulation. During the webinar, Technical Files for IVDR’, we will describe the requirements of the IVDR with respect to Technical Documentation and discuss options and formats for how to meet the regulatory requirements. Depending on the classification of devices and conformity assessment route, the technical documentation can be subject to assessment by Notified Bodies to ensure compliance with the requirements. The webinar will also explore key software considerations in relation to the requirements and will provide some insights on how to ensure compliance.
Key learnings:
- What the IVDR requirements involve
- How to prepare and compile Standard Technical File submissions in the right format and with the relevant content
- What Software considerations should be taken into account for the Technical Files
