EU representative details on Class I device

CharlieUK

Quite Involved in Discussions
#1
Scenario: UK manufacturer placing a Class I device onto market in Europe:

My understanding is that under the MDD, the name and address of the Authorised representative could be on the device or in the manual

My understanding of the MDR (Regulation (EU) 2017/745 ) is the name and address of the Authorised representative must be on the device (Annex 1, para 23.2)

Is that correct?

thanks
Charlie
 
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chris1price

Trusted Information Resource
#2
The name and address of the authorised representative must be on the label (not the device itself)

23.2. Information on the label

The label shall bear all of the following particulars:
(a) the name or trade name of the device;
(b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
(c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
(d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
(e)...etc
 

CharlieUK

Quite Involved in Discussions
#3
The name and address of the authorised representative must be on the label (not the device itself)

23.2. Information on the label

The label shall bear all of the following particulars:
(a) the name or trade name of the device;
(b) the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device;
(c) the name, registered trade name or registered trade mark of the manufacturer and the address of its registered place of business;
(d) if the manufacturer has its registered place of business outside the Union, the name of the authorised representative and address of the registered place of business of the authorised representative;
(e)...etc
Looking at 23.1(b) the label could be on the device or on the packaging if it's not "practicable or appropriate" to be on the product

The device is small and hand-held and there's a danger of plastering it in labels, so the preference would be to put EC REP on the product and representative name and address on the packaging - would that be acceptable?
 
#4
Yes (probably, see however ... bit) perfectly acceptable.

23.1(b) states that the information on the label should be on the label that goes on or on the device. Only when not appropriate you may stick the information somewhere else. That can be partial, or entirely.

X-ray equipment : plenty of room for the AR to be on the label somewhere.
Pacemaker: probably not very handy for the AR to be on the device somewhere.

However, note that you're not going to win an argument with a NB about label size and information that you put elsewhere when there is realistically more room on the device for more label, but decisions were made because of how the device would look with a bigger label. ie for cosmetic reasons for example.
 
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