The PQ IVD Assessment Team held a virtual Workshop on the 15th of March with in vitro diagnostic (IVD) manufacturers to provide an update on implementation of the Collaborative Registration Procedure (CRP). The objectives of this workshop were to highlight the CRP principles and objectives, the process for participation, the National Regulatory Authorities currently engaged and upcoming plans for expanding support of the collaborative process.
Presentations were delivered by the IVD Assessment and Facilitated Product Introduction Teams followed by a lively Q&A session. The workshop was attended by more than 80 participants with 34 manufacturers represented. Questions covering eligibility for the CRP, managing product changes and the role of the manufacturer in the process were answered during the workshop.
The IVD Assessment Team would like to thank colleagues in FPI and the IVD manufacturers for their active participation and feedback, we look forward to continued engagement with the CRP to enhance access to quality assured IVDs.
A recording of the workshop can be accessed at the following link: