Registation different version of Medical Devices & Germany competend authority

Stilts

Registered
My company would like to start cooperation with a company that is a manufacturer of a class I medical device (legal manufacturer and physical manufacturer according to MDR). The Manufacturer company is located outside the EU and has an Authorized Representative in Germany.
We would like to sell the product under our own brand as an importer in accordance with the option provided in Article 16 of the MDR (after signing the agreement).
We would like to buy one type of Medical Devices in two different sizes.
I have doubts about the registration obligation of Devices under our brand in two size versions.
To the best of my knowlage from MDR and MDCG, each type of Device differing in size, capacity, color, etc. should has a separate UDI-DI, so it should be registered separately in the Eudamed database. However, the Eudamed database is still optional and AR must register products with national competend authority.

I found the information for Northern Ireland and there the information on the MHRA website was clearly stated (in my opinion) that each product model/size must be registered separately.

device details:

-which legislation applies
-the class of device you are registering - if you are unsure of the classification and particularly if you are registering with a self-certification conformity declaration, please see Borderline products: how to tell if your product is a medical device
-Global Medical Devices Nomenclature (GMDN) code and term to describe your device
-Basic UDI-DI (if applicable)
-medical device name (brand/trade/proprietary name)
-model or version detail
-catalog/reference number
-UDI-DI (if applicable)
-UK Approved Body (or EU Notified Body) where applicable
-attributes such as sterility, contains latex, MRI compatible

However, I have not found information on German websites that could confirm that in the case of the German office, such registration of each size version / brand version is also required.
It seems logical to me that the requirements should be the same in all EU, but I can't find confirmation in German website.
I found the annex of the previous German Medical Devices Act and as I understand it, was used for the registration of Medical Devices. (Anlage 1(zu § 4 Abs. 1 Nr. 1 DIMDIV))
However, I do not see any data in that Annex for old german law there that would require/enable registration of each size/volume version, etc.
I can't find data on what data is currently required when registering Medical Device in Germany.
The manufacturer claims that it is not necessary to register Products with our brand and each size of the product separately.

Can you help me? Can you point me to where I could find such information about Germany? Who is wrong the manufacturer or me?
 

EmiliaBedelia

Quite Involved in Discussions
It seems logical to me that the requirements should be the same in all EU, but I can't find confirmation in German website.
It would seem logical, but that is not necessarily true for countries that require their own "in country" notification/registration :)

Generally if I cannot find specific requirements about what information is required, I like to look at the database itself to see what information is in there. I could not access DMIDS itself, but based on the user guides for the database, it looks as though the database registers by nomenclature codes (UMDNS) as opposed to product numbers. Just from what I can gather from Google Translate and the available screenshots, it appears as though you would register the UMDNS codes associated with each certificate/company, which would mean the manufacturer is correct.
https://www.bfarm.de/SharedDocs/Dow...epflichtige-mp-ivd.pdf?__blob=publicationFile

IMO, the easiest solution would be to ask the German Authorized Representative.
 

Stilts

Registered
@EmiliaBedelia Thanks a lot! I couldn't find this guide. This seems really helpful.

I also tried to access DMIDS to find this information but I couldn't and I don't know why I couldn't find this guide :unsure:
 

Mikilk

Involved In Discussions
as an EUAR located in Germany, I am responsible for the database registration of our clients, you do not require to enter the sizes.
Registation different version of Medical Devices & Germany competend authority
 
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