What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you?


Involved In Discussions
Hi everyone.
I’m new to the forum and so happy to have found so many people willing to share their expertise.

I am wondering how to interpret a line in the MDCG guidance 2020-3 on significant changes in relation to Article 120(3)of MDR. Its been a subject of much debate within our team, but I am still not clear on what the intention is so would be glad of your collective opinions.

Article 120 describes restrictions on changes to products on MDD certification under the MDR transitional provisions.

The scope section of MDCG 2020-3 states:

it is expected that manufacturers adjust their change notification procedures, i.e. their provisions to inform their notified body on changes, in accordance with the principles outlined in this guidance until the date of application of the MDR. The adjusted procedures will be subject to notified body assessment within their surveillance activities according to MDR Art 120(3).”

It’s the word ‘until‘ that is troubling me. Do they really mean until, or do they mean ‘before’

If they really mean until, doesn’t the sentence suggest that the MDCG guidance must be applied now to products on MDD certificates outside of the scope of MDR instead of following the current NBOG design change guidance, but guidance only applies until 26 May 2021? And that would make the 2nd sentence in quotes above meaningless wouldn’t it? NBs won’t be completing surveillance according to MDR 120 if your product is on an MDD certificate between now and May 2021.

Substituting ‘before’ for ‘until’ would seem to make the whole paragraph make sense. For me, ’before’ would mean that the NBOG guidance continues to apply to products on MDD certs, procedures must be updated to account for the MDCG guidance in relation to Art. 120 before May 2021 when the guidance will start to need to be used and NBs will be checking change notification procedures account for the guidance during MDR audits. Which is logical.

Am I completely off track?
There seems to be a lot of confusing wording in the MDR. You should reach out to your notified body to see what they expect from you.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
The message from our NB is "Your certificate for your device is approved until 2023; unless you make a significant change to it, then we will need to apply it to MDR review"


Involved In Discussions
I understand it that way: during the transitional provision (ie until the application of the MDR), you may market products under MDD certificates as long as no substantial changes (per MDCG 2020-3) are made on them. Consequently, to ensure you do it properly, you must update your change control procedure to replace NBOG notification criteria per those from MDCG. This QMS update will be reviewed during your follow-up audit, as the other MDR requirements applicable whether you market devices under MDR certificates or not (PMS, vigilance, etc).
Top Bottom