Standard review and gap analysis


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Hi, I have question regarding for standard application.

So, our company want to apply MDR soon and I am reviewing applied standards and I got one question.

I checked, MDR official website for which is acceptable standard for MDR. Refer below link. file:///C:/Users/Evan(Seonmin)Kim/Downloads/2017_745%20Medical%20Devices_Summary%20list%20of%20harmonised%20standards_Generated%20on%208.3.2024.pdf

I can not see EN 60601-1 standard in the list.
Our company performed test as EN 60601-1:2006 and I checked recent version is EN 60601-1:2006/A13:2024
Should we do gap analysis? or Is it okay to just leave as is since the standard is not on the list?

I am really confusing for how I have to prepare so please share opinions!


Peter Selvey

Super Moderator
I think the MDR is a bit dysfunctional on the standards front, possibly due to a high level mandate that the standards kind of need to be reasonable and clear about what cover (and don't cover) with respect to the GSPR, and a lot of the 601 series need a big overhaul to reach this higher bar.

In the meantime, or as a workaround, Notified Bodies are treating the newer versions of the standards as "state of the art" which is mentioned in GSPR #1 and other places. There is usually a 3 year transition period for new standards and amendments, and I would guess that NBs and regulators would respect this. IEC 60601-1 Edition 3.2 has been around since 2020, so the 3 years is over. There a lot more standards around e.g. EMC, software, other collaterals that might need a gap analysis as well, and the 3 year transition might be important.

The EN amendments like A13:2024 I don't know the detail but I guess does not affect the technical content and only provide interpretation and context such as relationship to the GSPR.

Might be useful if someone with recent experience with NBs can confirm if this is correct, as I'm out of the loop these days for the MDR.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
If it’s a standard relating to essential performance of your device you should do a deep gap analysis of the changes and if they affect you and how.
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