Technical Documentation 1 answer

IEC 82304: How Is It Different From The IEC 62304?

Anonymous · Updated December 16, 2024
We're just getting started with our medical device documentation, and we initially thought that we need to comply with the IEC 62304 regarding our software documentation. Now, someone mentioned the IEC 82304 and we're confused. What's the difference? Is this double the work?

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1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
Don't worry about it. Auditors won't like me for saying this, but the 82304 doesn't contain much additional content on top of the 62304. Just comply with the 62304.

Long Answer

I could write a lengthy answer to this one, but there's no reason to. The IEC 82304 is a standard which, in simple terms, aims to provide some clarifications on top of the IEC 62304. It mostly deals about validation of your software.

Some auditors expect you to "comply" with the IEC 82304, but this isn't a general expectation. Regardless, "complying" with the 82304, as a minimalist, would simply mean adding it to your list of applicable regulations and.. that's it. Because you're already complying with the 62304 and that already covers you pretty well for the 82304, there's simply not much you need to do on top.

Oh, and if you were wondering where to get the IEC 82304, use the friendly Estonian site to save lots of money, as always. In case you didn't know about the Estonian site yet, here's an explanation and here's a video. And here's a direct link to the IEC 82304 over there - at the time of writing, the price for the IEC 82304 on the Estonian site is ~24€, while the "normal" price is ~250€, if you can consider that "normal", given that you're paying money for a PDF.

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Anonymous 16 days ago
I might need to object although we have the same name ;-)

IEC 62304 is for SRS level and verification and 82304 for URS and validation. You can verify with 62304 that your software calculates the right dosage but you cannot validate the clinical claims with 62304. For this you need the 82304 level to refer to URS and trace to CER und Summative Evaluation. And there are NBs out there not only asking for adding it to the list but they acutally want to see how you meet the chapters of IEC 82304. Painful but it is happening.
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