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An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories?

RA_QA_Expert

Involved In Discussions
#1
Hi all,

MDR (Annex I, point 23.2q Information on the label) requires an indication that the device is a medical device.
Is that applicable also for accessories? Based on definition ‘accessory for a medical device’ means an article which, whilst NOT being itself a medical device.

Thank you in advance for clarification.
 
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shimonv

Trusted Information Resource
#2
Accessory is not a medical device per Article 2(2) and so it should not bear the indication for a medical device per Annex I, section 23.2(q).
 

James

Involved In Discussions
#3
Accessory is not a medical device per Article 2(2) and so it should not bear the indication for a medical device per Annex I, section 23.2(q).
For added clarity, all of chapter 3 applies to accessories (the accessory being 'the device' in all of the other clauses) apart from 23.2(q) which is explicit in stating "medical device"?

Thanks

James
 

L_O_B

Involved In Discussions
#4
That is correct.
'Devices' include medical devices, accessories and products listed in annex XVI (see article 1(4)).
'Accessory for a medical device' is by definition (see article 2(2)) not a medical device.
 

kunal9218

Starting to get Involved
#5
That is correct.
'Devices' include medical devices, accessories and products listed in annex XVI (see article 1(4)).
'Accessory for a medical device' is by definition (see article 2(2)) not a medical device.
But what if the manufacturer maintains the DHF as a device and not just as an accessory?
 

shimonv

Trusted Information Resource
#6
KP,
The way the information is organised, whether as one or in two separate DHF's does not change the definition of what an accessory is.
 
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