Economic Operators Responsibilities after DOA for legacy MDD devices

#1
I have been getting conflicting information recently regarding the responsibilities of economic operators after May 2020. What MDR obligations MUST authorized representatives, distributors and importers comply with by May 26th 2020 if they only handle legacy MDD devices? Is it everything listed as per Article 11, 13, 14 and 16 or just the registrations as per Articles 30 and 31?
 
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Ronen E

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#2
If you could please list the conflicting opinions you received so far, and who you received each from, it could be a good discussion starter.
 

L_O_B

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#3
I have a guess what this might be about and would be happy to have a discussion about this topic.

Scenario:
In the context of the MDR the manufacturer decides to cease his class I medical device activities. The devices are placed on the market until the date of application. The devices are made available and put into service even afterwards until May 2025.
Without a doubt the document retention requirements apply.
But what else is he required to do? Until when? And on what basis?
The first response I received on that topic was "MDR Vigilance".
Okay, having a look at MDR vigilance (article 87-90)
I know that Eudamed is delayed, but in theory, a manufacturer must register as such to be able to enter reports. Is the manufacturer required to do so, even if he never has placed a device on the market within the application of the MDR?

Article 88 describes trend reporting. To be able to report a trend, the manufacturer needs a PMS plan defining indicators and thresholds allowing the identification of a trend. Additionally, the manufacturer must assess the impact on the benefit-risk analysis. Therefore, I need an up to date CER for statements regarding the benefit of the device and an up to date risk management file for statements regarding individual and overall risks. This sounds like a lot of effort for someone who decided not to continue medical device business because it is to much effort.

And there are several other distinctions. What about someone manufacturing a class IIa or higher device, who wants to use the validity of his existing certificate?
Does he have to comply with the whole article 10 by the date of application? He is a manufacturer by the definition of the regulation. Article 120(3) only refers to device requirements:
"a device with a certificate [...] may only be placed on the market or put into service provided that from the date of application of this Regulation it [the device] continues to comply with either of those Directives [...]. However, the requirements of this Regulation relating to post-market surveillance, market surveillance, vigilance, registration of economic operators and of devices shall apply in place of the corresponding requirements in those Directives."
I recently had a conversation with a leading employee of a notified body and he emphasized that they would include all manufacturer related requirements of the MDR in MDD surveillance audits after the date of application.

I know that notified bodies are just as much guessing about the interpretation of the MDR as everyone else. But regarding this topic, I am missing the piece of text to confront them in case of a discussion.
 
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