Interpretation of MDR 2017/745 Article 23 - CE Mark Requirements

fialor

Involved In Discussions
#1
Hello Everyone,
I am in the middle of an MDD audit and my NB has dropped a huge bombshell with regards to the upcoming MDR which I disagree with.
I would appreciate it if anyone could shed some light on what their interpretation or their NB's interpretation of article 23 is.

My NB has advised that Article 23 means that going forward for the MDR (come implementation in 2020) all device critical components and sub-assemblies must be CE marked. The NB has advised that we begin to get our components and sub-assembly suppliers to get CE marking for their devices, in readiness for compliance with MDR.

I disagree with interpretation ( and I was not shy about it! :nope: probably not done myself any favours) but my understanding of the article is that "anyone who seeks to provide a replacement component on the market for a device must ensure that it performs to the same level as the original component that it is intended to replace."

I have have read and re-read article 23 a few times but cannot see anywhere that it says/states/implies that CE marking of critical components is a must?!
Or even any wording that I can stretch to mean that.

Your feedback would be very appreciated.
Fialor
 
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dgrainger

Trusted Information Resource
#2
Article 23 applies to components placed on the market to replace " an identical or similar integral part or component of a device". It's only adding the spare part guidance in MEDDEV 2.1/1 I.1,1b to the regulation:
Spare parts supplied for replacement of existing components of a
device, the conformity of which has already been established, are not
medical devices. If spare parts, however, change significantly the
characteristics or performances of a device with regard to its already
established conformity, such spare parts are to be considered as
devices in their own right.

There is nothing new!
 

fialor

Involved In Discussions
#3
I agree but somehow I cannot seem to get this into my NB and it worries me that this is the interpretation that this is being used to also offer training to clients by this NB. "Me" thinks I shall change NBs.




Article 23 applies to components placed on the market to replace " an identical or similar integral part or component of a device". It's only adding the spare part guidance in MEDDEV 2.1/1 I.1,1b to the regulation:
Spare parts supplied for replacement of existing components of a
device, the conformity of which has already been established, are not
medical devices. If spare parts, however, change significantly the
characteristics or performances of a device with regard to its already
established conformity, such spare parts are to be considered as
devices in their own right.

There is nothing new!
 

Marcelo

Inactive Registered Visitor
#4
Is this a formal position of your NB or a opinion from a NB auditor? Unfortunately, I'm seeing a lot of stupid remarks from NB auditors regarding the MDR (the last one I've seen was that instructions for use cannot be electronically anymore, which clearly means that the auditor has not read the MDR), but again I've always seen stupid remarks about the MDD also, so what I still suggest is is - you have to understand the requirements you have to comply with, not the NB :p
 

fialor

Involved In Discussions
#5
I agree MArcelo but in this instance it is most likely the same auditor who will run the NB CE review and this interpretation from the auditor only leads us down a path of incorrect NCs come the MDR audits. :confused:
 

Marcelo

Inactive Registered Visitor
#6
I agree MArcelo but in this instance it is most likely the same auditor who will run the NB CE review and this interpretation from the auditor only leads us down a path of incorrect NCs come the MDR audits. :confused:
You can always require a change of auditor, or complaint to the NB or complain to the EU Commission, or do all three together.
 

pkost

Trusted Information Resource
#7
As a first step I would suggest asking the technical manager at the NB to have a polite word with the auditor to ensure no misinterpretation of the requirements occurs in the future

Failing that your competent authority should be able to provide an email/letter confirming your interpretation which should get the NB to back off
 
#8
Yes, I also confuse what's the most interpretation for the article 23. what way can we comply with article 23? spare part procedure need to be established?

Article 23 Parts and components:
1.Any natural or legal person who makes available on the market an item specifically intended to replace an identical or similar integral part or component of a device that is defective or worn in order to maintain or restore the function of the device without changing its performance or safety characteristics or its intended purpose, shall ensure that the item does not adversely affect the safety and performance of the device. Supporting evidence shall be kept available for the competent authorities of the Member States.

2.An item that is intended specifically to replace a part or component of a device and that significantly changes the performance or safety characteristics or the intended purpose of the device shall be considered to be a device and shall meet the requirements laid down in this Regulation
 

chris1price

Trusted Information Resource
#9
I read Article 23 as saying, if you supply a spare part that does not change the performance, safety characteristics or intended use, you must have evidence to back up that position. If the spare part does make a change, you must CE Mark the spare part.

It is nothing to do with critical components or suppliers. Talk to your scheme manager, the auditor has definitely got it wrong.
 
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