IVDR timelines are running out! How does your IVDR readiness checklist look?
The regulatory challenges associated with the marketing approval of in vitro diagnostics often trigger barriers to diagnostic innovation.
Remember: The change of transitional provisions only applies to devices requiring the involvement of a notified body.
Do not put an halt in your remediation process!
Instead,
- identify gaps in your verification program and performance data
- determine the sufficiency of your clinical evidence
- plan and commit to realistic PMPF activities
- triple-check consistency of statements across your technical documentation
Evnia can help manufacturers navigate through the regulatory challenges of an IVDR transition journey!
