A lot of interesting stuff is going on - there's a new MDCG document on medical devices and the AI Act and there's another, updated MDCG document with a new MDR class I software example.

Additionally, we've been busy adding AI features to our eQMS software - check out one of them below, which helps you creates QMS trainings in seconds, not hours. It's pretty awesome.

Oh wait.. we also launched our new website, check it out below, too.

Ask Questions For Free On Our New Website

We've launched our new website which enables you to ask questions to people in our community, for free! Below are two examples.

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Class I situation and update of MDCG 2019-11: Qualification and Classification of SaMD

The MDR class I software situation was a mess back in 2020-2022, and, oh wait, it still is. We summarized it at the time with some examples, this was one of our most popular articles.

Now, the MDCG 2019-11 was updated on June 1st, with a new class I example. On LinkedIn, the regulatory consultants hailed this as a huge "clarification that MDR class I software is possible yadda yadda please contact us for consulting oh we'd like to charge you lots of money".

Cutting out the consulting-gibberish, there's actually not much new here. I don't think the new class I example offers much value, and the whole situation is still a mess of epic proportions.

Oh, right - the new class I example is an app which "converts a set of selected symbols into spoken language", e.g. for patients with cerebral palsy. To me, that doesn't even really sound like a medical device. Maybe I'm wrong. Regardless, it's yet another class I example which is not very relevant to the real world. It would have been much more useful to add an example which resembles the countless medical apps (DiGAs) which have been published in the meantime (50+), yet.. that probably would have been too useful, and the MDCG people prefer to write about abstract examples which are "safe" to write about, while sitting in their (tax-funded) ivory tower.

Download the full text on the website of the EU Commission.

MDCG 2025-6: Interplay between the MDR & IVDR and the Artificial Intelligence Act (AIA)

I'm not a fan of the EU AI Act, given that we don't have a whole lot of AI to regulate in the EU anyway as most of the (commercial) innovation is happening in the US and China, but I assume the EU had some good reasons to regulate AI (except that I don't know them).

Regardless, as a medical device manufacturer, the most relevant deadline here is August 2, 2027, as manufacturers then will have to integrate significant new requirements for data governance, bias mitigation, and transparency into their systems. The TLDR here is that it makes sense to do a gap analysis until then. There's a new MDCG 2025-6 (link) which contains some questions and answers.

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MDCG 2025-4: Guidance on the Safe Making Available of MDSW Apps on Online Platforms

It always astounds me how the EU (and the MDCG) manage to come up with even more guidance all the time. It seems the MDR is so vague that, mathematically speaking, it's possible to come up with an infinite number of guidance documents.

MDCG 2025-4 is one of those.

It's especially relevant for app developers. The guidance introduces clarifications on terminology and explains the obligations and responsibilities of app platform providers under the MDR, IVDR, and the Digital Services Act (DSA).

It outlines two main scenarios for app platform providers: acting as intermediary service providers under the DSA or as distributors or importers under the MDR/IVDR.

SaMD manufacturers must provide detailed information to app platform providers and the should select a clear "Medical Device" category on app platforms, distinct from general health or lifestyle apps. Read the full guidance here.

EU eIFU Update!

The EU has expanded the use of electronic instructions for medical devices (eIFUs) with Regulation (EU) 2025/1234.

• Expanded Scope: eIFUs are now allowed for all medical devices intended for professional use.
• Centralized Access: Manufacturers must link eIFUs to the EUDAMED database.
• Goals: This aims to increase digital access, reduce paper, and streamline workflows.

Read the full Regulation text here.

Update of Harmonized Standards for MDR & IVDR

The EU Commission updated the list of harmonized standards for both the MDR and the IVDR. The updates include standards for single use gloves or sterilization methods. Find the complete updates here.

That's it! Thanks for reading. If you haven't yet, check out Formwork, our eQMS software which is free to get started and will save you lots of time in your medical device compliance journey :)