MDR Classification Chaos and User Manuals

Dr. Oliver Eidel
Updated June 11, 2024
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Hey you,

we’ve published some new articles about regulatory stuff and the things we do. The first one is about the not-so-helpful new MDCG 2021-24 regarding classification of medical devices: Is an Apple Watch a medical device? Are radiology AI devices always class III? What can be deemed class I according to the new guideline? Check out the article.

There’s also a new case study where we helped solve regulatory problems of a class 1 MDD device for less than 2k. So efficient! The app is called BabyCare and it’s a preventive care program for pregnant women based on more than 20 years of experience and research, pretty cool. It’s even reimbursed by more than 70 health insurance providers. Read more about what we did and how it went.

And if you ever wondered whether you need to force your users to read the User Manual or if you could just let them be humans and not read it, we’ve got you covered here.

We hope you have a great Advent season and don’t get too annoyed by regulations. See you next year. Until then, Merry Christmas and a Happy New Year. Btw: We’re out of office in the first week of January.

Best Christmas wishes,
OpenRegulatory

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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