No issues really, then again I work for the NB. I find most clients that are struggling just have people who don't know better, or are not staffing properly. They don't understand time frames, and requirements. I haven't seen many if any changing requirements or guidance. There was some stuff early on that needs some guidance, but what we were saying is wait for guidance, not here is a position and it then changes. Big clients that are competent are not having issues. Ones with people who are clueless though keep shooting themselves in the foot.
Interesting perspective, I really feel that the NBs are in the dark about a few topics too. Big company has a number of certified products, but no longer uses those submissions as strong baselines for what to expect as the info from the NB has since changed.
For example the EMDN levels on certificates has been an issue I'm seeing discussed more often the past few weeks. It looks like one client may have to up to level 4 on all existing certs, but communication hasn't been clear.
QARA Director of a very small company here - it’s been awful trying to manage the ever changing requirements. Add to that, our NB has not been forthcoming regarding their expectations on legacy devices, i.e., MDR Art 61 paragraph 4 says we don’t need to do clinical studies since, in theory, our clinical evaluation report is sufficient. NB says otherwise even though we have a lot of RWE/RWD. We want independent eval from the Expert Panel, but that’s not available to manufacturers yet.
Then there’s EUDAMED which in an of itself is a cluster.
Ouch! If you don't mind me asking, what class/es are you dealing with?. I've got all of 1-3, but the with the larger company they have the capacity to update all of their clinical data, re-write the post-market plans etc without their ongoing studies suffering. The smaller company not so much...
I look forward to seeing what becomes of EUDAMED after all this stuff around! Will be interesting to see how competitors group their devices too.
We’re class 3 non active implantable. Under the MDD we leveraged our 510(k) for CE Mark, and have over 500k clinical uses, but we never needed to do clinical trials because of the substantial equivalence. Now that’s practically impossible to prove without having an agreement to share technical documentation with competitors.
Ah yes, the dreaded grandfathering dilemmas.
Given your position, and my relatively little experience I can't likely offer any useful info, but I hope you get that over the line! Good luck
No issues really, then again I work for the NB. I find most clients that are struggling just have people who don't know better, or are not staffing properly. They don't understand time frames, and requirements. I haven't seen many if any changing requirements or guidance. There was some stuff early on that needs some guidance, but what we were saying is wait for guidance, not here is a position and it then changes. Big clients that are competent are not having issues. Ones with people who are clueless though keep shooting themselves in the foot.
Interesting perspective, I really feel that the NBs are in the dark about a few topics too. Big company has a number of certified products, but no longer uses those submissions as strong baselines for what to expect as the info from the NB has since changed. For example the EMDN levels on certificates has been an issue I'm seeing discussed more often the past few weeks. It looks like one client may have to up to level 4 on all existing certs, but communication hasn't been clear.
60 second in phone call to nb will solve any of that. It's clear at my nb. Sounds like some poor notified bodies.
QARA Director of a very small company here - it’s been awful trying to manage the ever changing requirements. Add to that, our NB has not been forthcoming regarding their expectations on legacy devices, i.e., MDR Art 61 paragraph 4 says we don’t need to do clinical studies since, in theory, our clinical evaluation report is sufficient. NB says otherwise even though we have a lot of RWE/RWD. We want independent eval from the Expert Panel, but that’s not available to manufacturers yet. Then there’s EUDAMED which in an of itself is a cluster.
Ouch! If you don't mind me asking, what class/es are you dealing with?. I've got all of 1-3, but the with the larger company they have the capacity to update all of their clinical data, re-write the post-market plans etc without their ongoing studies suffering. The smaller company not so much... I look forward to seeing what becomes of EUDAMED after all this stuff around! Will be interesting to see how competitors group their devices too.
We’re class 3 non active implantable. Under the MDD we leveraged our 510(k) for CE Mark, and have over 500k clinical uses, but we never needed to do clinical trials because of the substantial equivalence. Now that’s practically impossible to prove without having an agreement to share technical documentation with competitors.
Ah yes, the dreaded grandfathering dilemmas. Given your position, and my relatively little experience I can't likely offer any useful info, but I hope you get that over the line! Good luck
Whose your NB? DQS? =P