Hello Anon,
At this point in time, I would highly recommend you disconnect any UDI requirements for the product and UDI information contained in EUDAMED.
First, UDI requirements for the product: regardless if EUDAMED is working or not, the actual physical product must have the UDI on the product labelling as of the dates defined in Article 123 for EU MDR and in Article 113 for EU IVDR. Thus based on the class of device of medical device/IVD the actual product needs to have the UDI by the required date.
Second, for EUDAMED when this is fully functional you would enter the UDI information into the EUDAMED database. The time of putting in UDI in the system has a few interpretations as when "fully functional" occurs if you read in the Articles basically the Commission has to publish a notice and there is then a 6 month (or maybe 18 month) period to input the data. However, just like the Actor Registration recently, there will probably be a period where you can voluntarily enter UDI information prior to EUDAMED being fully functional as these different modules are activated.
To answer your post, entry into the EUDAMED system is not so clear at this point - they say there will be modules available at different steps in the new few months/years, but not so clear when this "fully functional" action will take place (try to use fully functional and not go-live as this may introduce further confusing terms because go-live means you can use the system, not when you are required to use the system). More importantly the physical products needs to be labelled with a UDI number probably well in advance of a fully functional EUDAMED, so make sure you do not wait for UDI based on EUDAMED.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Apr-2021 11:33
From: Anonymous Member
Subject: EUDAMED UDI registration timelines
This message was posted by a user wishing to remain anonymous
Hi,
I am trying to understand the current timelines for UDI registration in EUDAMED given the current dates of application of EU MDR of May 2021 and EU IVDR of May 2022, the announced delay of the UDI module to September 2021, and an assumed date I've seen reported of May 2022 for the remaining EUDAMED modules including the Vigilance module.
Based on the MDCG 2019-4 guidance document on EUDAMED device registration timelines, would the following assumptions about UDI registration be correct IF the above dates hold true:
- Voluntary registration of UDI data for both non-IVD and IVD devices begins September 2021 (as soon as the UDI module goes live)
- Mandatory registration of UDI data for both non-IVD and IVD devices involved in a serious incident begins May 2022 (I'm arriving at this date assuming that a registered UDI becomes a precondition for devices involved in serious incidents once the Vigilance module goes live)
- Mandatory registration of UDI data for all non-IVD medical devices begins May 2024 (I'm arriving at this date assuming the full EUDAMED go-live announcement referenced in MDR Article 34(3) won't be until May 2022, which is after the general date of application of EU MDR of May 2021, so the mandatory registration deadline = date of go-live announcement + 24 months)
- Mandatory registration of UDI data for all IVD devices begins Nov 2023 (I'm arriving at this date assuming the full EUDAMED go-live announcement will be just before the IVDR date of application of May 2022, so the mandatory registration deadline = date of application + 18 months)
I realize that we must be prepared in general for UDI in advance of these dates, but I'd like to understand the obligations for reporting UDI data to EUDAMED. Do my assumptions look correct?
Thank you.