2017/745 Article 31 Single Registration Number

[fialor]

As a single business entity playing different economic operator roles under 2017/745 (manufacturer, importer), is a business required to have two SRNs (one as an importer and one as a manufacturer)?
Or is the business able to have one SRN for both roles?
Thank you!

 

[Marcelo]

Each economic operator needs to have it's number, so if you are two different economic operators, you will have one number for each (this was created in part because it was not clear to Authorities when an operator had more than one role/responsibilities in the regulatory system).

 

[fialor]

Each economic operator needs to have it's number, so if you are two different economic operators, you will have one number for each (this was created in part because it was not clear to Authorities when an operator had more than one role/responsibilities in the regulatory system).

Thank you Marcelo.
Could you point me in the direction of where I might find the wording? I cannot seem to see the wood for the trees!
Thank you!

 

[Marcelo]

It's not clearly written this way, but if you read article 31 1. and 2. with this in mind, you will see that it requires each one of the operators to require a SRN. It does not say anything on requiring only one if you has more than one role.

 

[Marcelo]

You can also see this in some other documents, such as MDCG 2018-6, where it mentions:

Relevant obligations arising from Article 16(1)
Any distributor, importer or other natural or legal person that assumes the obligations incumbent on manufacturers in accordance with Article 16(1), assumes all the relevant responsibilities related to UDI, including UDI labelling.
This means that those economic operators must also apply for registration as Manufacturers, receive a Single Registration Number (SRN), apply for the appropriate conformity assessment procedure and feed and provide UDI-product registration.

 

[Marcelo]

And the EUDAMED specifications.