The new IVDR transitional periods that have been published in January 2022 took some pressure from all of us who still need to re-validate a bunch of IVD-products for IVDR-compliance.
Nonetheless, there is no time to lose! Clinical performance studies take longer than you might expect.
Did you know that by law a German ethics committee has 30 days to give you their opinion on your study plan (§36 Medizinprodukterecht-Durchführungsgesetz)?
Furthermore, most clinical performance studies must be approved by governmental authorities. By law, they have 45 days to send you their final statement.
Additional delays, for instance when specialised information is required by ethics committee or authorities, or when external experts are to be consulted, are not considered here.
This means that even in the case of no unnecessary delays there is a potential lead time of 2,5 months only to receive the approval to start with the clinical performance study.
Because of this and other factors, oftentimes there is simply not enough time to meet our client’s deadline for submission of the technical documentation to the notified body.
Long story short: Don’t hesitate to contact us for the clinical validation of your products. Time is running short already! Include a minimum of 9 to 12 months for the clinical performance study in your planning.