The Commission is already making it way more complicated than it needs to be already with introduction of EUDAMED DI and EUDAMED ID (anyone with dyslexia?) when the system has not have been established yet. I will wait with baited breathe on how it actually ends up and more importantly the usability of the system.
The real crux of problem with legacy products with the absence of EUDAMED, UDI-DI, Basic UDI-DI is the fact the MIR form already has this information included. Luckily it is not mandatory at this time, but I have heard in some conferences the EUDAMED vigilance reporting will require entering the Basic UDI-DI or some type of identification for legacy products. Therefore, it "forces" legacy products to get a Basic UDI-DI even for all those MDD products.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 09-Jun-2019 09:19
From: Dan O'Leary
Subject: UDI for legacy devices and MDR
I infer that you are referring to MDCG 2019-5 on registering legacy devices. The guidance document defines a legacy device as a device on the market under the Article 120(3) transition. The device must meet the MDD requirements, not the MDR requirements. However, one of the elements in the Article 120(3) transition is device registration. Under Article 29, the device manufacturer takes three steps to register the device: a) assigns a Basic UDI-DI [Art. 29(1)], b) populates the device database in Eudamed [Art. 29(4)], and c) populates the UDI database in Eudamed [Art. 29(1)].
There is an MDCG document that says the manufacturer does not have to populate the UDI database until the applicable dates in Article 123(3)(f).
In my opinion, MDCG 2019-5 attempts to resolve a problem that does not exist. It says, "the MDCG considers it appropriate to adapt the Eudamed design to allow the registration of legacy devices in Eudamed in the absence of a (Basic) UDI-DI".
However, there is no reason for an absent Basic UDI-DI. MDCG 2018-1 version 2 provides information on the Basic UDI-DI, MDCG 2019-1 provides information for issuing agencies on the Basic UDI-DI, and at least two of them have implemented the Basic UDI-DI and published information about it.
The Basic UDI-DI does not appear on any packaging or labeling. It is administrative and is for the DoC, certificates, etc.
The underlying assumption is that between the start of the Article 120(3) transition and the UDI dates in Article 123(3)(f) the manufacturer will not have assigned a Basic UDI-DI or a UDI-DI. However, in certain cases, such as an incident report, the manufacturer will need them.
The solution is to create two short term identifiers, a Eudamed DI and a Eudamed ID. They would exist in Eudamed only. The Eudamed DI is a surrogate for the Basic UDI-DI, so it would not appear on label. The Eudamed ID is a surrogate for the UDI-DI and is only for the database, so it would not appear on a label.
The Eudamed DI and the Eudamed ID are for the UDI database only, so, at least that portion of Eudamed must be functional.
There is an issue with the UDI-DI used in the US. The UDI-DI encodes the version or model of the device. For some devices the European version is not the same as the US version. For example, there may be different versions because of the AC mains differences. The US does not require the UDI on devices for export, so some companies may not have assigned a UDI-DI for the European version.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 08-Jun-2019 21:25
From: Rashmi Pillay
Subject: UDI for legacy devices and MDR
Hi ,
For legacy devices ( devices compliant to the MDD ) Eudamed DI and Eudamed ID is applicable instead of the Basic DI and UDI –DI . So does that mean the labels need to be changed to bear these codes during the soft transition period and these would be in addition to the UDI for USA . Can these be implemented only after the EUDAMED becomes live as one of the codes is provided by EUDAMED?
Thanks & Regards,
Rashmi Pillay
Regulatory Affairs Associate
Ellex
3-4 Second Avenue
Mawson Lakes SA, 5095
W ellex.com
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