Specific Country Requirements for Medical Device Registration in Europe

Hi,

My company is located in Asia and we already got CE mark. Can anyone tell me that should i do the registration process for each country? Or i already can sell my product to EU now??

If i need to do registration for each country. Can anyone tell me how to do that? Is there any guidance or summarized document to instruct me how to do that? Thanks so much....

Eric

flyjly said:

Hi,

My company is located in Asia and we already got CE mark. Can anyone tell me that should i do the registration process for each country? Or i already can sell my product to EU now??

If i need to do registration for each country. Can anyone tell me how to do that? Is there any guidance or summarized document to instruct me how to do that? Thanks so much....

Eric

Click to expand...

Hi Eric

The product registration can be done through manufacturers with registered office in member states or authorized representative or distributors. I advise you to contact your European Authorized representative or the competent authority of the Member State where you intend to market your products. The contact details of national authorities can be found at http://ec.europa.eu/health/medical-devices/files/list-of-contact-points-within-the-national_en.pdf

Hi Eric,

First of all welcome to the cove. For starting with your products in the Eu you definetly need an EU-Representative. These are companies located within the EU which overtake the responsibility for your products in the union. Search google or especially this forum to find some more infos on this. Normally this representative manges the registrationprocess for the countries and helps you with special questions for each country, for example language demanded on packaging for each country. To find a rep please use google or ask around in this forum.

Regards,

phloQS

If you are looking for a good understanding, read the related threads

Eric-

Your EU Authorized Representative usually takes care of registering the devices in the individual countries. An EU Authorized Rep is required. The EU Commission released a guidance document on the Authorized Reps earlier this year. I can't post links yet, but if you google "MEDDEV 2.5/10 EU Authorized Representative," it should come up. Hope this helps!

Sarah