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

Dr. Oliver Eidel
Updated December 16, 2024
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Question

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?

Short Answer

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.

On a slighty different note: You want to get your medical software certified under MDR but don’t know where to start? No worries! That’s why we built the Wizard. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.

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