Economic Operators, EU Market Access

[dchinny]

Good evening.

Hoping for some clarification on my experience and understanding of selling MD's and IVD's in the EU.

I've been involved with a few companies who have developed a device, demonstrated regulatory compliance & registrations up to Class IIb, marketed and as hoped, sold said devices to customers in most member states.

Another project being worked on is compliant to 98/79/EC, got BS EN ISO 13485, registered with the MHRA, have appointed and reference an Authorised Rep, and have duly registered the device in another EU Member state through the AER however, one CA is insisting that in order for us to sell the device (IVD) in Spain, we are required to have an importer/and or distributor in Spain, registered with them as an economic operator before we can market the device (Royal Decree). I can't work out if this is a new requirement, a consequence of Brexit or something I have managed to get away with for 20 years!

I completely get economic operators (although I see there being some challenges down the line referencing the Blue Guide and the definition of "Fulfilment Service Providers") but if we are in compliance then doesn't that mean that the compliant company is permitted to sell the compliant device to a customer in the EU.

any sounding board would be appreciated
With Thanks

 

[ond1n3]

Hello! I don't know about Spain and IVDs, but for medical devices, for all companies I worked for and with, in order to conduct business in Spain a local legal entity must formally register with the local Competent Authority and have a license for distribution of medical device. This requirement dates way before the term economic operator appeared in the EU MDR. I don't think you "got away" with it before, but maybe your Spanish distributor had such a license - which is NOT product specific, but company and category specific - ie. distribution of medical devices . Hope this helps!

 

[dchinny]

HI

Thank you for coming back to this post. I have just checked with two Spanish distributors and yes, as you intimated, both are registered with AEMPS.

thanks again