Hi,
Once a device is CE marked (whether under MDD or MDR) with one of the EU CAs, does it still need to be registered locally with other EU countries where you intend to sell?
There is lot of conflicting information available online. Seems Italy definitely needs a separate registration?
Can someone guide on this and preferably point in the direction with a list of such countries?
Thank you
Yes, there are several countries where you need to notify in the specific country before you can sell there. Italy is one, and also (off the top of my head) Spain, Portugal, Germany, among others... IMO it would be easier to identify the countries you specifically want to sell in and then check if they require registration.
The difficulty is that each country can make their own regulations, so there really is no "official" hub of information - either you will need to do the digging yourself, or you can pay for info that someone else has researched. If you are starting from square 1 with registration, it may be worth it to work with a consulting group (there are tons) who will help you get registered, as some countries require an in-country contact in order to register. Most of the resources you'll find online are from consulting firms, so you may be able to get access to comprehensive regulatory resources for future reference.
If you are going to be DIY-ing, there are many sites where you can find some quick info on country-specific regulations - I like to use these resources as a starting point, then go to the country's health agency page and use Google Translate to confirm. I generally like RegDesk as a quick reference
European Union Medical Device Regulations | RegDesk
