It's been a while. Regulatory-wise, the last few weeks can be summarized as "the EU has your back", as the EU was busy introducing new regulations for the benefit of all its people, people like you and me who regularly suffer from veggie burger mis-labelling and not having our chat messages scanned. Specifically:

• I'm sure you're aware of this common problem: When shopping for groceries, you purchase a "veggie burger", and you end up being very disappointed because the "veggie burger" doesn't contain any meat - it happens to all of us. The manufacturer had the heinous marketing idea of calling it a "burger" and not putting any meat inside! Luckily, the EU parliament has now voted to ban meat names for plant-based foods. So, in the future, when "veggie burger" will be called "round veggie thing with bread", this surely will be way less misleading.
  Disruptive idea: Set up a EU-wide database of veggie products to monitor manufacturer's adherence to proper labeling. Let's call it EUDABURGER.
• I'm sure you're also aware of this common problem: You're messaging your friends private messages and start thinking "man, it would be a great idea if the EU scans all my private messages so that we could finally combat crime properly". Turns out, the EU also had this great idea of becoming a surveillance state in its Chat Control proposal. Fortunately, it was narrowly averted by Germany finally remembering that mass surveillance was bad historically and voting against it. Unfortunately, the proposal tries to get passed every 1-2 years or so.

So yeah, the EU has your back. I'm looking forward to the Digital Euro which should now be launched in 2027, brought to you by the people who are competent at software development and still haven't finished pouring millions of Euros into building a SQL database for medical devices.

With that EU optimism in hand, let's move on to medical devices!

Free Risk Management (ISO 14971) Video Course (new!)

We recorded a brand new video course on risk management. As always, it's super concrete as I won't lose any time by boring you with reading out regulations to you. Instead, I walk you through documenting a real-world medical device. Take a look:

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Here's the link to all videos of the course. In the next few days, we'll also be launching a course on usability engineering based on the IEC 62366. Subscribe to our YouTube channel here to receive a notification when it's live!

Notified Body Survey on Certifications and Applications

The EU Commission conducts surveys among the 51 designated Notified Bodies. The NBs are still a major bottleneck. On the one hand, the number of applications for an MDR certificate is at an all-time high (28,069 in October 2024), which is crazy. On the other hand, the waiting times are incredibly long. More than half of the NBs need an average of 13-18 months for the QMS Audit + TechDoc Review. Oh boy. You can find the full report here.

You want to share your personal "experience" with your NB? No problem, we set up the great Notified Body survey. Add your review and help all manufacturers make the industry more transparent.

EU MDR Updates

• Updated Borderline classification manual. Some new examples, among other things, medical calculators apparently are class IIa. We can prepare for (online) medical calculators becoming unavailable as most manufacturer's won't be able to reasonably go through the NB bureaucracy of getting simple calculators certified. I'm sure it's safer if physicians manually type in formulas into their phones and send the results around as WhatsApp screenshots..
• Starting Nov 1st (that's tomorrow), a new update to the MDR comes into effect. It only concerns labelling of glasses (yes, seriously).

FDA Updates

• FDA De-Novo submissions can now only be sent via the eSTAR system. Here's the form.
• There's an updated guidance document for software validation (this concerns the software you use for development (IDEs etc.), but not the libraries built into your product).

New Articles

• Electronic Case Report Form: FDA vs. MDR
• Turtle Diagrams
• Design History File
• 5 Phases of Medical Device Development

Digital Health Jobs Re-Vamped

It's still hard to find a job in digital health, but we've been busy improving our Digital Health Jobs website which now contains almost 3k jobs in digital health. Check it out!

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And that's it for this update! If your company is looking for a great and affordable eQMS software, check out Formwork - our free migration service will help you migrate if you're currently overpaying for your eQMS (our pricing is 99€ or 499€ / month).

Have a great weekend!
Oliver