Its here! After 5 short years, through Brexit and Covid-19, the deadline for IVDR transition is now less than 30 days away – where did the time go?!
I have spent the majority of my time within Regulatory Affairs being aware of the IVD Regulation, either in draft form, or as a published text. 5 years was always going to be a challenging timeframe, even without the additional complications we have seen in the last 5 years. The new regulation presents a seismic change to the way IVDs are regulated in the EU.
Many companies have made steps to be ready for the transition, either having updated to IVDR compliance, or are in process, taking into account the additional time limits for classes A (sterile) B, C and D. However some are still chasing their tails to get ready for the deadline.
Key areas of focus for IVDR DOA
- Post-Market Surveillance
- Vigilance
- EUDAMED registration
- Technical Documentation Processes
- Person Responsible for Regulatory Compliance
It is critically important that the IVD industry is aware of the changes, and what needs to be updated to be compliant by the date of application. IVDeology have a great team of friendly experts who are working with multiple IVD manufacturers get ready for IVDR compliance, Contact me for further information on how we can help you. [email protected]
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