Authorized (EC) Representative Contract and SOP

Cuffern

Starting to get Involved
#11
Hi,

Does anyone know if a non-eu based manufacturer opens up an office in the EU - does this mean an authorised rep is not needed or, if it is needed, can the EU office be the authorised rep?

Thanks!
 
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fialor

Involved In Discussions
#12
Hi Cuffern,
Article 14.2 states if there is no "registered place of business" - see screenshot below .
So if your non-eu based manufactured continues to be registered in a non-EU country, then yes an EU AR is required.

And yes - in that instance your EU Office be your EU AR. It is important to remember the EU office will need to fulfil the same requirements as your other EU AU.


Yes - Unless the 1549295898427.png
 

somashekar

Staff member
Super Moderator
#13
Please see Article 11 , Article 12 , Article 15 , Article 31 of the EU MDR.
The AR is an economic operator and will have all the obligations in the EU as much as the manufacturer.
At almost all places the EU MDR mentions "Manufacturer or its Authorised Representative"
.
..
(35) For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.
 
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