Re: Specific country requirements for medical device registration in Europe
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.