The requirement for the techical documentation to be kept on EU soil was never 
enforceable in practice and has been removed from the directives re-issued 
under the New Legislative Framework. 

The appointment of an Authorised Representative is optional for all directives 
except for the ones which deal with medical devices. 

The Machinery Directive (and the new Marine Equipment Directive, which is not a 
CE marking directive) requires there to be someone who can act as a delivery 
point for the technical file who is resident in Europe. This is not the same 
role as that of an Authorised Representative. 

Nick. 


> On 1 Nov 2016, at 21:40, Nyffenegger, Dave <[email protected]> 
> wrote:
> 
> I recall the authorized representative is optional for MD and LDV with 
> respect to who is responsible for placing product into market, either 
> manufacturer or authorized representative.  However, the party responsible 
> for the technical file must be resident inside the EU.  If the manufacturer 
> is not resident inside the EU then there must be an authorized representative 
> who is and identified on the DoC/DoI.
>  
> -Dave 
>  
> From: Kunde, Brian [mailto:[email protected] 
> <mailto:[email protected]>] 
> Sent: Tuesday, November 01, 2016 4:20 PM
> To: [email protected] <mailto:[email protected]>
> Subject: Re: [PSES] Authorised Representative
>  
> John,
>  
> In reference to what?  The name and address displayed on the EE?, the 
> responsible party within the EU?, information appearing on the DoC?
>  
> I’ve always understood that an Authorized Representative within the EU was 
> required for manufacturers outside the EU; and I thought this was a 
> requirements for most all Directives (I’m not familiar with all of them).
>  
> The Other Brian
>  
> From: John Allen [mailto:[email protected] 
> <mailto:[email protected]>] 
> Sent: Tuesday, November 01, 2016 3:32 PM
> To: [email protected] <mailto:[email protected]>
> Subject: [PSES] Authorised Representative
>  
> Hi,
>  
> I always thought an Authorized Representative was required for Machinery but 
> option for other Directives.  I searched Machinery and LVD and only see 
> manufacturer "or" authorised representative.
>  
> If I'm wrong please point me to the particular section of the Directive.
> 
> Thanks,
>  
> John
>  
>  
>  


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