National registrations for MDR certified devices in absence of EUDAMED

#1
Hi, I'm looking to gather information on registration requirements within the EU for MDR certified devices.
Under the MDR, Eudamed will be the central registration system, however as Eudamed has been postponed until 2022, the national requirements for secondary registrations apply.
I know that in Ireland with the HPRA there is a parallel registration system for MDR devices. So you have to submit a seperate registration for MDR certified devices and indicate whether they are legacy devices or new devices. There is no guidance document available from the HPRA, however when you email them, they will send the information and spreadsheet which needs to be completed for MDR devices.
They have also advised that companies keep their MDD registrations up to date until the expiry date of the last MDD product registered has passed.
I'm wondering about registrations in France, Spain, Italy etc... Have these countries introduced new processes for MDR registrations?
 
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#2
The MHRA (UK) registration portal has options to record and register based on the conformity assessment and certification of the device being done under the MDD, MDR, IVDD or IVDR. I assume that this was done as a stop-gap until Eudamed is ready. The latest version of their registration user guide (September 2019 (v1)) does include guidance around registering under the MDR & IVDR, which is pretty helpful, so good on them!
Being unfamiliar with the HPRA registration process I'm afraid I can't help you with your specific problem, sorry.
 
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