The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
The window for watching and waiting on IVDR has firmly closed. For manufacturers of in…
For manufacturers, authorised representatives, and distributors of medical devices and IVDs in the EU, the May deadline represents the moment when full EUDAMED requirements take effect across all relevant modules. With just 60 days remaining, the time for gradual preparation has effectively passed.
This article outlines the key actions still required, highlights where organisations most often fall short, and provides guidance on navigating the final stretch before the EUDAMED deadline without making costly mistakes.
Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.
To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.
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Register and learn all the details about EUDAMED, the European database for medical devices and In-vitro diagnostics!!