EU IVDR Readiness Assessment Checklist

EU IVDR readiness checklist from Emergo by UL

This brief checklist will help you to determine how to bring your in vitro diagnostic medical device company into compliance with the EU IVDR.

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Is your company ready for the implementation of the European In Vitro Diagnostics Regulation (IVDR)?

Under the IVDR, in vitro diagnostic (IVD) device CE Marking requirements will be substantially different. Device manufacturers need a clear picture of their progress and outstanding needs in order to ensure compliance to the new Regulation and guarantee continued European market access.

Our European IVDR Readiness Checklist helps you determine what steps you have already taken to comply with the new Regulation, and it assists you to identify which areas require more work to satisfy new requirements. The checklist will help you to answer the following questions:

  • Will our IVD classification change under the IVDR?
  • Does our current quality management system meet IVDR requirements?
  • Is a gap analysis between our current In Vitro Diagnostics Directive (IVDD) and IVDR compliance needed?
  • Does our current Technical Documentation meet IVDR requirements?

Find out what your company needs to do to attain IVDR compliance for CE Mark certification with our Checklist.

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