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July 7, 2023

Maybe Harmonized Standards Are Becoming Freely Available Soon

Dr. Oliver Eidel

Let’s start off my quoting my 30-year-old self, in the depths of the pandemic of 2020, unemployed and ranting about standards:

You might think that if certain rules apply to all companies of an industry that those rules should be freely available. Like law. Law texts are freely available. That makes sense. Because everyone in a country must comply with the law. And it’s easier to comply with the law if you can read it for free.

Currently, that’s not the case for the standards you need to comply with if you’re manufacturing a medical device, such as medical software. The ISO 13485, for example, is PDF file which you have to purchase to a price anywhere between 30€ and 150€, depending on which shady website you choose (check out our article on accessing standards to learn how to save money).

That might be changing. It seems that two organizations have taken on this fight with the EU - public.resource.org and Right to Know. I checked out their website and, from what it seems, they 1) don’t have fancy websites, 2) get straight to the point and 3) prefer to take real legal action instead of ranting on a website (which would be me). For all of those points, I respect them a lot.

Based on my broken understanding of the EU legislature, they filed a complaint with the EU Advocate General. And now, that Advocate General, a person named Laila Medina, has looked into the complaint and actually arrived at a similar conclusion:

“Advocate General Medina considers that, for the purposes of EU law in general and for the access to EU law in particular, and, given [Harmonized Technical Standards] indispensable role in the implementation of EU secondary legislation and their legal effects, they should, in principle, not benefit from copyright protection.”

So this is a fancy way of saying that those standards should be free.

Check out the quite well-readable EU press release here and the much more difficult to read actual opinion here.

If you like what those organizations are doing, check out the websites of public.resource.org and Right to Know and consider donating to them as they are nonprofits (I hope I got the links right - please correct me if I’m wrong!). The Right to Know people also seem to run a website called TheStory.ie on which they posted their own announcement of the EU Advocate General opinion.

What’s next? Building again on my broken EU legislation understanding, the next step now would be that the EU judges (?) have to deliberate (?) the case and arrive at some sort of conclusion (?). I don’t know when that will be and what we can expect.

But it’s cool to see other organizations fighting to fix these broken aspects of our current system, and that there’s a democratic process to give those complaints a fair chance based on their merit.

Who knows, maybe we’ll have free standards in the future.

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 some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

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No QMS on this planet will save you from creating crappy software.