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

RA_QA_Expert

Involved In Discussions
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.
 

shimonv

Trusted Information Resource
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
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
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.
 

destroyed9218

Involved In Discussions
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
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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