Authorised Representative Contact Information

Mark Meer

Trusted Information Resource
#1
Curious:
I've been scanning the MDD, MDR, and MEDDEV 2.5/10 for references to required Authorised Representative contact information, and all I can seem to find is that only name and address are required.

Is this correct?

Aren't they are supposed to be contactable within a timeframe from anywhere in the Union? If so, just providing a physical mailing address seems inadequate to this purpose, no?

Presently, we do also list phone/fax/email on our labelling & DoC...but strictly by the regulations, am I correct that only a mailing address would suffice?
 
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Marcelo

Inactive Registered Visitor
#2
The authorized representative is an operator that is only relevant to the authorities and NBs ands those already have the full details, so they would their contact information be made available in general?
 

Mark Meer

Trusted Information Resource
#3
The authorized representative is an operator that is only relevant to the authorities and NBs ands those already have the full details, so they would their contact information be made available in general?
Isn't one of their tasks to "immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;" (MDR, Article 11, 3(g))?

True, in practice, it's unlikely that complaints would be routed through the AR, but the presence of this clause seems to infer that the AR could be contacted with complaints. Further, if only authorities and NBs are relevant, why the requirement to put the AR address on labelling at all?
 

Marcelo

Inactive Registered Visitor
#4
Isn't one of their tasks to "immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;" (MDR, Article 11, 3(g))?
Yes, but please note that they are not required to formally have a system for that, nor healthcare professionals, patients and users are required to notify them (this usually goes to the distributor/importer in each country). So, this is more for the (normally rare) cases when they receive this information

True, in practice, it's unlikely that complaints would be routed through the AR, but the presence of this clause seems to infer that the AR could be contacted with complaints. Further, if only authorities and NBs are relevant, why the requirement to put the AR address on labelling at all?
Probably because of the need for an AR in the first place: you have to include the address of someone in the EU the "represents" contact the responsible manufacturer abroad.
 
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