Come and hear Shaun Day from Greatland Gold #GGP, Cathal Friel and Jeremy Skillington from Poolbeg Pharma #POLB, George Bennett from Rainbow Rare Earths #RBW and Helium One CEO David Minchin #HE1 present tomorrow evening. Register here.
There is a proposal to pushback implementation of the new IVD regulation by a number of years depending upon the criticality of the device. SARS-COV-2 tests will be class D devices meaning highest risk and the proposal for these is to pushback to 2025 (from 26May22)
This will be great news for smaller manufacturers lime omega as it means they will still be able to sell product without conforming to all the extra processes needed to be IVDR compliant.
It's great news for healthcare in general as a lot of on market products were at risk of going off market. The new regulation requires 100 percent of product to be reviewed by a notified body before ce marking compared to roughly 8 percent currently. There's only 6 notified bodies currently for 1000s of products.
A fair point handome. All of the notified bodies are currently unbelievably snowed under with work to support implementation of the new IVD regulations still due to go live on 22 May 2022
For those not Informed about this the IVDR means that there is no more self certification for CE mark, a notified body must conduct a technical review of every single product and approve before CE marking.
Crucially this means every company must resubmit and get third party approval for every single IVD product currently on market as well as new products if they wish to sell more batches that are manufactured after 22 May 2022. There are also not enough notified bodies currently.
Hello Regulator I switched companies and my new building has no phone reception. The antisocial gits! I'm also in commercial now so no doubt will be telling everyone to ignore all the regulations to get the product out sooner. Haha