Informational EU – Official position on EUDAMED delay

Marcelo

Inactive Registered Visitor
#1
The Commission concluded that it will only be possible to make EUDAMED operational once the entire system and its different modules have achieved full functionality and have been subject to an independent audit. Therefore EUDAMED’s launch will be done together for medical and in-vitro medical devices, at the original date foreseen for in-vitro medical devices i.e. May 2022.
The date of application of the MDR remains May 2020.

From European database on medical devices (EUDAMED).

Posted at Marcelo's Medicaldevice.expert website...

You may comment and discuss in this discussion thread.
 
Elsmar Forum Sponsor
#2
Does anyone know the impacts of this delay on legacy devices? According to Article 120 (3) of MDR, legacy devices shoul comply with the requirements of vigilance, post-market surveillance and registry of economic operators and devices. Without EUDAMED, none of these are possible, so as far as I know by the date of application of MDR legacy devices won't be affected at all. It will be as MDR doesn't even exist. Am I seing this right?

Thanks in advance.
 

Asia78

Involved In Discussions
#3
No, you are seeing it wrong.
"requirements of vigilance, post-market surveillance" are of course possible and mandatory also without eudamed also.to mdd devices.

The registry of economic operators and devices are instead postponed, yes, but as a manufacturer you still have the obligation to know and be in control of your distributors and check the information of the manufacturer if your company is importing devices into the EU. IT is just that the check is not done in eudamed
 
#4
Thank you for your answer Asia78.

But my questions kind of remains.
The requirements of vigilance and PMS are mandatory, but without EUDAMED to whom do you report them? To you national competent authority?
What do you do with PSUR? Are you still obligated to present it to your NB?
By what means do you report a serious incident? To your national competent authority? That basically doesn't change anything in comparison to the MDD.
 
#5
Thank you for your answer Asia78.

But my questions kind of remains.
The requirements of vigilance and PMS are mandatory, but without EUDAMED to whom do you report them? To you national competent authority?
What do you do with PSUR? Are you still obligated to present it to your NB?
By what means do you report a serious incident? To your national competent authority? That basically doesn't change anything in comparison to the MDD.
With MDR EUDAMED delayed all reporting reverts to the MDD rules. It is only when EUDAMED becomes fully functional that the reporting via MDR EUDAMED is mandatory. Currently, the date for this is May 26th 2022, the only time this could change is if the EC pushes an implementing act that would change the fully functional requirement.
 

levatorsuperioris

Involved In Discussions
#6
No not MDD rules, you still need to meet the requirements of the MDR. You would send them to your NB who will have to keep track of them until EUDAmed.
 
#7
No not MDD rules, you still need to meet the requirements of the MDR. You would send them to your NB who will have to keep track of them until EUDAmed.
No not MDD rules, you still need to meet the requirements of the MDR. You would send them to your NB who will have to keep track of them until EUDAmed.
Article 123 (3) points to the use of existing Medical Device Directive (MDD) communication methods and this works for registrations, clinical investigations, and vigilance reporting as those provisions are existing systems in the MDD.
All reporting remains as is under MDD, however, the MDR reporting is not specified but expected to follow the MDR rules and all reporting to follow MDD communication channels.
 
#8
I understand that EUDAMED will Go Live on 26th of May 2022, what is the due date for registering the economic operators for legacy devices under MDD?
I understood from MDCG 2019-4 Timelines for registration of device data elements in EUDAMED Issue April 2019 that there is an 18 month period to register legacy medical devices. Is my understanding right or I have to register the economic operators by 26th of May 2022?
Thanks
 

debbie gallagher

Starting to get Involved
#9
My understanding is that the new foreseen time for EUDAMED to become fully functional is Mid 2023 which will give a mandatory time of end of 2023 for registration of economic operators.
 

Raisin picker

Involved In Discussions
#10
When I check the EUDAMEd page, i see:
Info (2020-12-03)
The first module of EUDAMED: Actor registration was made available on 1 December 2020. The Commission is not in a position to require the use of the module until EUDAMED is fully functional according to the Medical Device Regulation (MDR) and additional national requirements on registrations can therefore not be excluded. A MDCG Position Paper on the use of the EUDAMED actor registration module and of the Single Registration Number (SRN) in the Member States was published in August 2020: MDCG 2020-15
and
Info (2021-10-04)
The system is available again and the UDI/Devices and NBs Certificates modules are open. ...
This means, you can already register actors and devices (and yes, I've seen a number of manufacturers and devices already in the database). I see no benefit in waiting for the last day.
 
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