One of clarifications or slight wording changes in the EU MDR is that "accessories" can be classified on their own without automatically taking on the class of the parent device. There are a few instances where the accessory is actually a higher classification than the parent device. My suggestion is that you clearly define "the products" and how they are used. Accessories can be optionally used, must be used with a device, used in conjunction with, etc., that needs to be clearly defined by the organisation. There is not always a straight answer and it would depend on the device you are talking about, but if you wanted to regulate them independently of each, it would mean a Technical Documentation file for the device and the accessory separately. In each of these it would need to be clear how they are used together. However, caution must be applied because interpretation and application by Notified Bodies is not always the same - some have a strong "system" view that accessories used with device that needs the device to function, would be a "system" and therefore take on the highest classification. While we can all in this community give some great advice, different scenarios, citation of the regulation with specific interpretation, or some very helpful information ... the person sitting across from the table reviewing your technical documentation is your Notified Body - you should inquire with them how they will regulate your products. (But with that said, propose to them how it would be regulated to get their agreement; just do not ask them how to regulate them.)
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 27-Aug-2018 17:47
From: Peter Miko
Subject: Accessory Classification EU
Dear Colleague,
I think, the "accessory" you refer to is another medical device in the EU terminology. Both in the MDD and the EUMDR an accessory stands for a medical device' "…..which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s)."
The 2nd device should be classified accordingly.
I believe, that the relationship of the devices you have mentioned, in the EU terminology is 'interoperability' (the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to: .. working together as intended).
Regards
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Peter Mikó M.D
ArtPharm Ltd.
Gyermely
Hungary
Original Message:
Sent: 27-Aug-2018 13:07
From: Sheemah Kazi
Subject: Accessory Classification EU
Hi Everyone,
Our medical device is a class Ia measuring function and accessory is Class-IIa. Uptil now, the accessory had it's manufacturer's CE mark on it, now we plan to put our CE mark on the accessory. My question is will the accessory classification affect our medical device, since the accessory classification is higher than the device?
Thanks,
Sheemah
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Sheemah Kazi
QA/RA coordinator
United States
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