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! 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
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! 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