IVDR Readiness

Preparing for IVDR implemantation

EU IVDR Implementation Readiness

"Perhaps unsurprisingly, there appears to be less concern about the IVDR, which comes into force in May 2022, although almost two thirds of those surveyed have not worked with a notified body for an IVD product before.

The biggest unknown seems to be around clinical data requirements for IVDs. As the IVDR edges closer, companies will be hoping some important lessons from the implementation of the EU MDR can be learned."

Philip Greenfield, Medtech Insight

Respondents are split when asked how prepared their company is to hit the EU IVDR deadline

61% of respondents say that increased guidance from the European Commission is the main thing needed to be fully prepared for IVDR implementation

Working with Notified Bodies

65% of respondents have never worked with a Notified Body for an IVD product before

What impact has Notified Body allocation had on your company in regards to IVD products so far?

*Excluding 'Not Applicable' (36)