It is not a surprise, the obligations of distributors are now specified in the European medical devices (MD) and in vitro medical devices (IVD) Regulations, whereas the Directives did not mention it.
But what about their obligations regarding UDI and EUDAMED, the two new key measures of the Regulations ? Let’s do a check in!
Regarding the UDI, there is only one obligation for all distributors: checking that the manufacturer has indeed assigned an UDI to the device. To do this, distributors may apply a sampling method that is representative of the devices supplied.
In addition, if they make class III implantable MD or IVD listed in an act adopted by the Commission available on the market, the distributors must store and keep, preferably by electronic means, the UDI of this devices (article 27 MD Regulation / Article 24 IVD Regulation)
Regarding EUDAMED database, the distributor is the only economic operator who does not have to register. You may wonder why? The reason is simple: to avoid double declarations, both on EUDAMED, and at national level. Indeed, Article 30(2) of the MD Regulation and Article 27(2) of the IVD Regulation provides that member states may maintain or introduce national provisions on registration of distributors.
While the obligations relating to these two new key measures of the Regulation are less stringent for distributors, this key actor still has to comply with a number of other requirements. Go to article 14 to discover them! 😊