Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi Community,

I was reading the 'blue guide' today and I have question about how the definition of 'making available' correlates with the importer obligations.

 

In particular: The blue guide states that 'The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.'

 

Consider a non-EU manufacturer that manufactures IVD kits in batches. Each batch may consist of 100 kits all with the same lot number but each kit is sold separately.  Is the requirement under the IVDR for the Importer into the EU to perform the verification obligations (article 13) for each individual kit?, or will it be acceptable for the importer to perform the verification checks once per lot? My assumption is that the importer will perform this activity for every shipment they receive from the non-EU manufacturer.

 

The verification activities of the UDI: Will each of the above 100 kits have their own UDI? Or will it be lot/batch specific? In other words, each kit within a batch will have the same UDI uploaded to EUDAMED? Or will there be 100 different UDIs per batch?

Lastly - for legacy products making use of the progressive roll out (article 110), it seems that the system identified in MDCG 2019-5 can be used but is not mandated (if that can also be applied to IVDs) and that a full UDI system is not yet required. I am basing this assumption off MDCG 2021-25 (MDR specific but likely also applicable to IVDs) which states article 27 UDI system is not applicable.

Appreciate any insights

Thanks

Hi Anon

The factsheet for importers has some helpful explanation about batches and the difference between a "device identifier" and a "production identifier".  https://ec.europa.eu/health/system/files/2020-09/importersdistributors_factsheet_en_0.pdf

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Anne LeBlanc
United States
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Original Message:
Sent: 30-Mar-2022 21:35
From: Anonymous Member
Subject: IVDR - UDI and Transitional Provisions

This message was posted by a user wishing to remain anonymous

Hi Community,

I was reading the 'blue guide' today and I have question about how the definition of 'making available' correlates with the importer obligations.

 

In particular: The blue guide states that 'The concept of making available refers to each individual product, not to a type of product, and whether it was manufactured as an individual unit or in series.'

 

Consider a non-EU manufacturer that manufactures IVD kits in batches. Each batch may consist of 100 kits all with the same lot number but each kit is sold separately.  Is the requirement under the IVDR for the Importer into the EU to perform the verification obligations (article 13) for each individual kit?, or will it be acceptable for the importer to perform the verification checks once per lot? My assumption is that the importer will perform this activity for every shipment they receive from the non-EU manufacturer.

 

The verification activities of the UDI: Will each of the above 100 kits have their own UDI? Or will it be lot/batch specific? In other words, each kit within a batch will have the same UDI uploaded to EUDAMED? Or will there be 100 different UDIs per batch?

Lastly - for legacy products making use of the progressive roll out (article 110), it seems that the system identified in MDCG 2019-5 can be used but is not mandated (if that can also be applied to IVDs) and that a full UDI system is not yet required. I am basing this assumption off MDCG 2021-25 (MDR specific but likely also applicable to IVDs) which states article 27 UDI system is not applicable.

Appreciate any insights

Thanks