Requirements for Selling Class I Medical Device in Germany

[Mangafanga]

Hello,

I have a Class I medical device (non measurable/non sterile). I have followed the EU MDR requirements of self certification and registered my company in EUDAMED, awaiting SRN as well as taken the Basic UDI-DI. The company is local to Germany (not importing anything). Can you help what additional requirements (apart from EU MDR requirements) I need to follow to sell the Class I medical devices in Germany?

 

[shimonv]

I think you are good to go
You might want to check if you need to register (list) your device with the German component authority.

 

[Mangafanga]

Thank you.
Where do I check If I need to register the device with German competent authority?

 

[shimonv]

You can check in their website. Listing was a requirement under MDD. I doubt that it is also under MDR, bur worth checking.

 

[Mangafanga]

I know a similar manufacturer who has sold class medical devices, but never registered with the competent authority during the MDD time. Is that a problem? Will becoming EU MDR compliant including EUDAMED registration now solve this problem?

 

[Billy Milly]

Until Eudamed is fully functional on all modules (and only then obligatory), member states can set their own rules for registrations/listings - which are in most cases same as under MDD.

 

[Vetty007]

This is a good question, before MDR you can simply register your device on dimdi, and you can still do this, but its said to be not valid. According to the Bfarm, at the moment and until EUDAMED is working for product registration, it should be sufficient to inform the relevant "Regierungspräsidium". In any Case you can contact and ask them, how to proceed. Even or Esp. if they say, that there is nothing required, its always good to have something formal at hand......