The checklist is a great tool for the transition to the IVDR with your current IVDD compliant products. Are you not tired of the Notified Body answer: “What you have done for the IVDD essential requirements (ER) will not be sufficient. There is definitely more for you to do with the IVDR GSPR."
The checklist will provide an immediate status of the compliance evidence for the IVDR GSPR with utilizing the IVDD ER information. We expect that for the majority of products - in particular, the lower risk class products compliance may already be quite well established with the current information available for the IVDD ER. However, as long as you cannot prove this you may lose it.
The exact differences are laid out therefore; even subtle variances will be caught. Should the current information not be sufficient, this tool will support you to identify and provide the chance to address them quickly. The sooner those gaps are identified, the better.
Once each gap is closed, you will establish full compliance.
This tool is also tremendously important to make use of the “soft transition” with your IVDD certificate. This document as well provides for the IVDD compliance. It fully supports the IVDD certificate for the time being. Meaning you will not be forced to maintain two set of documents. And certainly make it part of your QM System.
Once all gaps are addressed, then your product compliance is established and you are ready to tackle other IVDR aspects with the confidence that your product is safe and performs as intended!