Summary of safety and clinical performance and Article 120(3) of the MDR

#1
Once again I find myself contemplating on the mysteries of the MDR. This time, wondered into the the forest of Article 120.
As everyone knows by now, indent 3 of this article states that:

"By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose. 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."

Now, Article 83 (Post-market surveillance system of the manufacturer) indent 3 dictates that:
Data gathered by the manufacturer's post-market surveillance system shall in particular be used:
... (d) to update the summary of safety and clinical performance referred to in Article 32

Now, I may be overthinking things here but, to me, this establishes a link between devices certified under the MDD and the MDR requirement for SSCP, so that should PMS data carry some value that could serve a trigger for SSCP update, even if the the device is still certified under the MDD, this would require creating/updating SSCP.

BSI seems to be somewhat indecisive on this issue, acknowledging that "PMS is linked to PSUR (Article 86) and SSCP (Article 32)" on one hand, and that "SSCP is outside of the requirements of Post-Market Surveillance (PMS), Market Surveillance (MS), Vigilance, Registration of Economic Operators and Registration of Devices and hence doesn’t apply for MDD devices" on the other (both views expressed in the same webinar and its Q&A; attached)

Has anyone here faced a request from an NB for SSCP for devices that are still certified under the MDD?
 

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Rincewind

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#2
Hello,

yes, we have, still under MDD and had to submit a SSCP, we are still struggling where to upload this as long as EUDAMED does not offer the possibility where the upload would be the NB responsibility.
 

Raisin picker

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#4
we are still struggling where to upload this
Check MDCG 2021-1 (Page 6 bottom).

And regarding the original question, you should see it from this perspective:

Since May 2021, MDD is gone, and MDR applies now to all and every (non-IVD) medical device. But wait, there are a few exemptions where the old rules/certificates can still be used. These exemptions are listen in Article 120.
So, the MDR does not list what to do with your MDD devices, but lists where you can still apply outdated MDD rules for MDR devices. Everything that is not mentioned under these exemptions has to follow MDR rules.
And yes, the wording is sometimes a bit cryptic, and not everything seems to make sense, but we still have to live with it.
 
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