Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

Under MDR classification rules, are power cords considered accessories for an active medical device (classification IIb under Rule 12)? Do they need to be CE marked and listed on the DoC?

Thanks.

Ref. Article 2:

'accessory for a medical device' means an article 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);

​

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Anne LeBlanc
Manager, Regulatory Affairs
United States
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Original Message:
Sent: 06-Oct-2020 11:08
From: Anonymous Member
Subject: Power cords

This message was posted by a user wishing to remain anonymous

Hello,

Under MDR classification rules, are power cords considered accessories for an active medical device (classification IIb under Rule 12)? Do they need to be CE marked and listed on the DoC?

Thanks.

Hello,

We always generally considered the power cord as part of the "system" and even not an accessory.  If the system was CE Marked, then this included all those other items like power cords.  I might consider only CE Marking a power cord separately is if the power cord was being used in many different applications including non-medical ... but then most likely would not be CE Marked under the EU MDR/EU MDD.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Oct-2020 19:39
From: Anne LeBlanc
Subject: Power cords

Ref. Article 2:

'accessory for a medical device' means an article 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);

​

------------------------------
Anne LeBlanc
Manager, Regulatory Affairs
United States

Original Message:
Sent: 06-Oct-2020 11:08
From: Anonymous Member
Subject: Power cords

This message was posted by a user wishing to remain anonymous

Hello,

Under MDR classification rules, are power cords considered accessories for an active medical device (classification IIb under Rule 12)? Do they need to be CE marked and listed on the DoC?

Thanks.

This message was posted by a user wishing to remain anonymous

There is nothing new in this rule - and also not in the accessory definition - compared to the MDD.
And there are also more possibilities to deal with this kind of (sub-)product.
One could treat the cord like a multi-purpose product - or as part of the medical device within the BOM.
In both cases the cord needs no CE mark as a medical device.
However, it should have already one from the RoHS directive.
Original Message:
Sent: 06-Oct-2020 11:08
From: Anonymous Member
Subject: Power cords

This message was posted by a user wishing to remain anonymous

Hello,

Under MDR classification rules, are power cords considered accessories for an active medical device (classification IIb under Rule 12)? Do they need to be CE marked and listed on the DoC?

Thanks.

I agree with Richard and others that have replied after him.  I have never seen a power cord as an accessory pother than in very unusual circumstances and would not recommend that route.  If you CE Mark the power cord then it likely would fall under the Low Voltage Directive and would not be a medical device + RoHS, WEEE, and other applicable directives/regulations.  The cable for the cord in Europe would also probably need to meet <HAR>which the power cord supplier should be able to show compliance with.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 07-Oct-2020 04:55
From: Anonymous Member
Subject: Power cords

This message was posted by a user wishing to remain anonymous

There is nothing new in this rule - and also not in the accessory definition - compared to the MDD.
And there are also more possibilities to deal with this kind of (sub-)product.
One could treat the cord like a multi-purpose product - or as part of the medical device within the BOM.
In both cases the cord needs no CE mark as a medical device.
However, it should have already one from the RoHS directive.
Original Message:
Sent: 06-Oct-2020 11:08
From: Anonymous Member
Subject: Power cords

This message was posted by a user wishing to remain anonymous

Hello,

Under MDR classification rules, are power cords considered accessories for an active medical device (classification IIb under Rule 12)? Do they need to be CE marked and listed on the DoC?

Thanks.