A webinar for IVD manufacturers was held on 26 June. The session was designed for applicants new to the prequalification process. Presentations were made by the IVD Assessment Team to describe the aim and scope of prequalification, the technical specifications for eligible IVDs, key points for performance evaluation, product dossier and labelling review, as well as the change request procedure. Following the presentation questions from the participants were addressed covering a range of issues, including TSS documents, multi-analyte IVDs, pre-submission meetings, quantification of specimen panels, clinical study locations, which option to choose for performance evaluation and the typical timeline for the PQ process. Many thanks to the 93 participants from 21 different countries that joined the webinar and helped make the session interactive.
If you were unable to join the live webinar a recording is available using the link and password below:
Passcode: Bh*z^sk5