Be confident of IVD medical device market approval
The complex development process for in vitro diagnostic medical devices combined with the anticipated changes, can make the transition a complicated and time-consuming process for most device manufacturers.
The resources below provide information and checklists to prepare you for EU's IVDR. Download these resources to ensure the latest information and guidance in your IVDR journey.
See at a glance where IVDR requirements are fulfilled.
Sampling for Assessment of Technical Documentations according to IVDR Annex IX
The Process from A - Z according to Annex IX
An overview on how to submit a Technical Documentation
What are the requirements for products that were already on the market under IVDD?