You seem to be asking several different questions, which might or might not be interrelated.
I don't see a question about medical device registry requirements in the rest of your post. I think you may be asking if the EU MDR (or associated MEDDEV) provides requirements for registries? I am not aware of any such requirements.
If you have an MDR-designated NB lined up, It would be the one to ask. Who knows, it might even have time to get a reply back to you before May 2020. Alternatively, if you have the money, I'm sure most CROs will find the time to get back to you quickly. At least long enough to get you to sign on the dotted line. Or you can do some research and DIY.
In the meantime, if by "run," you mean "set up our own," I would explore two issues: 1) patient protection and 2) valid scientific evidence, especially if you are planning to DIY. That's because everything I've been following on registries has been by way of FDA's Patient Engagement Advisory Committee. I don't know what's going on in the EU with registries, but I've found that what actually makes sense does so worldwide. And these two issues make sense.
At some point, I'll come back and give you a link the materials associated with the Advisory Committee, some of which addresses registries and might be of interest/help to you. Unfortunately, FDA has been trying to "modernize" itself, including its website, and as of right now, the links are missing or broken. Sigh.
(HOW CAN THERE NOT BE A "SIGH" EMOJI???)
What Marcelo said.
Again not sure what you are asking. You might be asking whether there are now requirements for observational studies in addition to the clinical data requirements under the MDD, In that case, what Marcelo said. You might be asking what requirements apply to the registries, but then "additional" doesn't make sense to me, so I won't attempt answer that question unless you confirm that this is the one you are asking.
I have a question on Medical device registry requirements per new EU MDR. We are looking for an opportunity to run a registry in the Ireland.
If you have an MDR-designated NB lined up, It would be the one to ask. Who knows, it might even have time to get a reply back to you before May 2020. Alternatively, if you have the money, I'm sure most CROs will find the time to get back to you quickly. At least long enough to get you to sign on the dotted line. Or you can do some research and DIY.
In the meantime, if by "run," you mean "set up our own," I would explore two issues: 1) patient protection and 2) valid scientific evidence, especially if you are planning to DIY. That's because everything I've been following on registries has been by way of FDA's Patient Engagement Advisory Committee. I don't know what's going on in the EU with registries, but I've found that what actually makes sense does so worldwide. And these two issues make sense.
At some point, I'll come back and give you a link the materials associated with the Advisory Committee, some of which addresses registries and might be of interest/help to you. Unfortunately, FDA has been trying to "modernize" itself, including its website, and as of right now, the links are missing or broken. Sigh.
(HOW CAN THERE NOT BE A "SIGH" EMOJI???)
Also, we are compliant to MEDDEV 2.7.1/4 for Clinical Evaluation. Under new MDR, do we require to present further clinical data?
And what are the additional requirements (if any) for observational clinical studies per MDR?