The In Vitro Diagnostic Regulation (IVDR) date of application is fast approaching and the EU Commission has already submitted an amending regulation for discussion in the Council and Parliament.
Manufacturers still have a grace period to complete and update their technical documentation to meet notified bodies expectations and to comply with the Regulation requirements in terms of Clinical Evidence.
Clinical evidence must be available for all legacy devices and data can be obtained from different sources, such as, for example, clinical performance studies, scientific peer-reviewed literature, and published experience gained by routine diagnostic testing. The clinical performance studies shall be linked to the plan for post-market performance follow-up.
The documentation shall contain the results and critical analyses of all verifications and validation tests and/or studies undertaken to demonstrate conformity of the device with the requirements of the regulations and, in particular, the applicable general safety and performance requirements.
This means, for IVDR:
- Information on analytical performance, clinical performance, and clinical evidence according to Annex XIII of Regulation (EU) 2017/746
- Performance evaluation plan
- Scientific validity report
- Analytical performance report
- Clinical performance report
- Clinical evidence and performance evaluation report
- Draft of the summary of safety and performance
The list is not comprehensive, but just a few examples of what the regulatory requirements are. Manufacturers will need to comply with a challenging deadline to meet these regulatory requirements!
Join this 4-hour course to hear from Dr. Sascha Wettmarshausen, Head of Regulatory Affairs at VDGH e.V. (German IVD-Association) and from Stefanie Giesener Head of Quality Management & Regulatory Affairs at DiaSys Diagnostic Systems GmbH, talk about what clinical evidence is under the scope of the IVDR!