MDR - Economic Operator Accountability

[Daithi Galway]

I have an Irish medical device distribution company. We don't manufacture. We have a sister company in the UK.
We buy a finished CE marked medical devices from a French Manufacturer, but through previous contracts/agreements they will only ship to the UK sister company.
The device is going from France (EU) to UK (Third Country) to Ireland (EU) where we distribute it in Irish Hospitals.
We have registered as an Importer and a Distributor with HPRA.
Do we need to register as the Authorised Rep too if the product is unchanged?
Do we need to register as the Authorised Rep if the product has an additional label added with our company name etc?
Thank You.

 

[Ed Panek]

The OEM is in EU. Is it having anything modified in UK?

 

[Daithi Galway]

Hi Ed,
Couple of potential routes - possibly adding to the Label such as Company name/logo but still maintain OEM details - batch number etc.

If the labelling was more than that, I think we could be squeezed into the Obligations of a Manufacturer?

Potentially, if we buy product from say Japan or Malaysia it will be straightforward accountabilities, we would be importer, Distributor and Authorised Rep.

It’s all great fun!

Thank You!