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.
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?
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.
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?
