Swissmedic, has recently issued a revised version of a guidance document that addresses In Vitro Diagnostic Devices. This updated guidance document includes new documentation and changes on the notification of IVDs.
Read Swissmedic’s full update here.
Key points to note:
The following changes have been made to the previous guidance document:
A front page has been added, which includes new information on:
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- Document IDs
- Version
- Publication date
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A list of new content and questions were also added, including:
What is the procedure for completing the notification form for inhouse IVDs?
Here Swissmedic gives a proposal for a possible procedure for completing the notification form.
As stated in the notification form for in-house IVDs, the declaration according to Art. 5 para. 5 let. f of the IVDR needs to be submitted: what is this declaration and how should it be drawn up?
Here Swissmedic gives a description of the declaration, and links to MDCG 2023-1.
If you have any questions or require further clarification on Swissmedic’s recent changes on IVD notifications, please contact us. Our team is ready to discuss how you can ensure compliance.