The survey on the updated Post PQ Change Request process and PQDx 121 guidance shows that manufacturers are broadly satisfied with recent improvements to the system. Respondents reported that the revised guidance, updated submission form, and overall workflow have increased clarity, predictability, and efficiency in submitting and managing change requests for prequalified and EUL listed IVDs.
Manufacturers agreed that PQDx 121 is clearer and easier to apply, particularly in defining documentation requirements and categorizing changes by impact. The new submission form was widely viewed as helpful in guiding applicants, although several respondents requested more explicit instructions for complex or legacy changes. Interactions with the AMD team were consistently rated as constructive, and the timeliness and justification of assessment decisions received strong positive feedback.
While satisfaction levels were generally high, respondents also identified opportunities to further strengthen the process. Key recommendations included improving the usability of the ePQS portal—especially for navigating older change controls—addressing temporary labelling inconsistencies that may delay shipments, and providing additional clarification on language requirements in Public Reports, fee exemptions, and expectations for component level documentation. Several respondents also encouraged more rapid updates to Public Reports following assessments.
Overall, the results indicate that the updated PQDx 121 guidance has notably enhanced the change request experience for manufacturers, with targeted refinements likely to yield additional efficiency and clarity.
We thank all respondents for their feedback.