National registration of madical device in EU

[Yaoliuer]

I have a classⅢ medical device have been CE Marked under MDR regulation, what shall we do to launch this product in all EU COPUNTRIES?
1. Translate the laungages
2. National registration（I am here for help which countries need national registration）

 

[Philip B]

Are you based outside of the EU? If so, you will need an EU authorised representative in order to place goods on the EU market. They will be able to advise on national requirements. They would probably also assist you in making registrations, but charge extra for this.
If you are in the EU, various consultants offer info on national requirements. Some of it is freely available online if you have a search.

 

[Yaoliuer]

Yes, our company based outside of the EU. We have EU authorised representative who charge this, but we think they charge us too high. Therefore, we want to do some national registration by ourself.

 

[Philip B]

Are you using distributors? They might be able to help with national registrations.

 

[Raisin picker]

Every national health system has a homepage where you can (try to) check that. Should be cheaper that asking an expert who takes the responsibility. What have you found so far? At least in some countries, you must have your AR perform the registration anyway.
I think it's safe to say that (almost?) every EU country needs active registration of medical devices.

 

[Mangafanga]

Yes, our company based outside of the EU. We have EU authorised representative who charge this, but we think they charge us too high. Therefore, we want to do some national registration by ourself.

Be mindful that if you think if you register with the competent authorities then you would not be required to have an Authorised representative of you (foreign manufacturer). Authorised representative in practical means a domicile of a particular country in Europe. You as a foreigner cannot be immediately domicile. Your best option to not engage an authorised rep would be to actually get a physical place in Europe, hire people and register that company, does it look cheap to you?

 

[Yaoliuer]

Be mindful that if you think if you register with the competent authorities then you would not be required to have an Authorised representative of you (foreign manufacturer). Authorised representative in practical means a domicile of a particular country in Europe. You as a foreigner cannot be immediately domicile. Your best option to not engage an authorised rep would be to actually get a physical place in Europe, hire people and register that company, does it look cheap to you?

Thanks for your reply, yes, EAR conducts the national registration on behalf of non-EU is the best choice.

 

[Yaoliuer]

Every national health system has a homepage where you can (try to) check that. Should be cheaper that asking an expert who takes the responsibility. What have you found so far? At least in some countries, you must have your AR perform the registration anyway.
I think it's safe to say that (almost?) every EU country needs active registration of medical devices.

Thanks, it seems that EAR conducts the national registration on behalf of non-EU is the best choice. We, as the non-EU manufacturer, may ignore some aspects if we do it by ourselves, even with distributors' help.

 

[Vetty007]

This is an interessting question, that I had discussed with the german authority in 2022, that told me, that the device company only needs to state the sales countries to their NB, who then shares this information. Thus I was informed, that I couldn't do a national registration of a device and I was thus thinking, that this is a general procedure. Luckily there is no other sales country, so that I haven't checked the other countries regarding registration requirements.