With this overview, we would like to give you all relevant information about the general In Vitro Diagnostic Regulation (IVDR) implementation status and state of play at DiaSys.
We have already re-classified all our devices, but this is still preliminary. DiaSys can finalize the re-classification with the valid guidance from MDCG, which is expected to be published by MDCG in Q1/Q2 2020.
In future, the conformity assessment will take place with the involvement of the notified body (class B, C and D devices). DiaSys is already in contact with their notified body and has discussed the new processes. Related SOPs are under revision but also for those procedures; some detailed questions are still open.
A gap analysis identified missing data and documents. Now DiaSys will update all relevant technical files to bring all product documentation in compliance with the new regulation. Concerning new quality agreements according to the IVDR, many details are still under discussion that will have an impact on those agreements, e.g. responsibilities of the economic operators, reporting, and content of EUDAMED. Therefore, DiaSys cannot offer any new agreements at the moment.
The project group, responsible for the labeling, has already created in a very early stage the new label templates to fulfill the new requirements as soon as they are needed. Within the same group also the instruction for use and manuals for instruments are under preparation. Now we are waiting for the last details concerning the UDI related requirements that will have an impact on how the traceability for each device can be assured.
This group awaits in Q1 2020 the necessary templates for the required reports. As soon as details about content and way of submission for such reports are available, the group will start to implement the necessary measures.
R&D of new products and our legacy devices
The related SOPs are under revision and new requirements are already considered during development. The finalized gap analysis for all legacy devices identified all missing data and documents. The measurement of missing data is in process and related technical files will be updated systematically.