Self-test In Vitro Diagnostics (IVDs) are medical devices that allow individuals to perform diagnostic tests on themselves, typically outside of a clinical setting, to monitor or diagnose various health conditions. Examples of self-test IVDs include home use pregnancy tests, blood glucose monitors and over the counter Covid-19 tests. These devices play a critical role in empowering patients, offering convenience and privacy, and enabling earlier detection of health conditions.
Transitioning from the European Union's previous In vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) is a challenging process for manufacturers, especially those producing self-test IVDs, as it requires compliance with more rigorous documentation, clinical evidence and post-market surveillance requirements, ultimately to ensure the safety, effectiveness and reliability of IVDs. For self-test IVDs, the transition also emphasizes the importance of clear instructions for use, user safety and accurate results to protect users and public health.
This webinar aims to equip manufacturers, during this crucial transition period, with the necessary information to ensure their devices remain on the market and compliant with the higher standards set by the IVDR.
Agenda
- What are self-tests and classification?
- IVDR transition deadline and provisions
- Regulatory requirements for self-tests
- Q&A
Language: English
Cost: No Charge
