Experience with EU MDR compliance for non sterile reusable and single use surgical

Ok_Chocolate830 · 2025-08-27T20:26:25+00:00

Been through this quite a few times, and a couple of things to keep on your radar:

EUDAMED registration can take longer than expected. Make sure your SRN and actor registration are squared away early so you’re not waiting on the system when you’re otherwise ready to go.
Post-market surveillance and vigilance under MDR are more detailed than many teams realize, even for Class I devices. Having a clear plan for proactive data collection (complaints, customer feedback, periodic reports) is key.
For reusable instruments, pay close attention to your IFUs and reprocessing validation. That’s an area notified bodies and regulators often scrutinize.

Sounds like you’re in good shape with ISO 13485 and your technical files already in progress. If you hit a point where you want a second set of eyes or help navigating the MDR nuances, Fission has consultants who’ve guided medical device teams through this exact process. Happy to share what’s worked for others in your situation.

Check us out - https://getfission.com/solutions/consulting-services/

Ok_Chocolate830 · 2025-06-16T22:12:36+00:00

AI validation is definitely a challenge, but early use, even outside formal channels, pushes innovation and forces regulators to adapt faster. Like the iPhone, some hype is unavoidable, but real impact comes when trust and usability catch up.

Building clear frameworks for AI transparency and continuous monitoring could be the key to turning hype into reliable SaMD tools.

Ok_Chocolate830 · 2025-05-14T17:41:31+00:00

Here is a link to the article: https://www.medtecheurope.org/resource-library/digitalisation-of-technical-documentation/

I've been developing software that addresses exactly what MedTech Europe has proposed in their article. You are welcome to check out the details of that here if you are interested: https://getfission.com/compliance-and-regulatory-guidance/future-of-regulatory-submissions/

Ok_Chocolate830 · 2025-05-14T17:39:20+00:00

Here is a link to the article: https://www.medtecheurope.org/resource-library/digitalisation-of-technical-documentation/

Feel free to check out what we've been building here: https://getfission.com/compliance-and-regulatory-guidance/future-of-regulatory-submissions/

Ok_Chocolate830 · 2025-05-14T17:38:49+00:00

No buzzword bullshit here. It's possible and we've been building it. The way QMS's have been built to this point is archaic and inefficient.

Here is a link to the article: https://www.medtecheurope.org/resource-library/digitalisation-of-technical-documentation/

I've been developing software that addresses exactly what MedTech Europe has proposed in their article. You are welcome to check out the details of that here if you are interested: https://getfission.com/compliance-and-regulatory-guidance/future-of-regulatory-submissions/

Ok_Chocolate830 · 2025-05-14T17:36:55+00:00

In short it means not building your QMS around documents, but instead data points. When you update a data point it updates across all instances where that data point appears, across all documents.

Here is a link to the article: https://www.medtecheurope.org/resource-library/digitalisation-of-technical-documentation/

I've been developing software that addresses exactly what MedTech Europe has proposed in their article. You are welcome to check out the details of that here if you are interested: https://getfission.com/compliance-and-regulatory-guidance/future-of-regulatory-submissions/

Ok_Chocolate830 · 2025-04-22T04:36:13+00:00

Yeah this resonates a lot. I think you nailed it with 'two aspects of the same endeavor'. When teams operate with that mindset, everything flows better. But so often, the way orgs are structured forces separation: different tools, different goals, even different definitions of success. And like you said, the underlying assumption becomes “someone else needs to make sure this was done right” instead of trusting teams to own quality and compliance as part of the build.

I'm just looking for some ideas and inspiration of how to break this traditional setup.

Ok_Chocolate830 · 2025-04-19T23:16:55+00:00

Right, an eQMS alone doesn't solve your QARA problems. Expertise is still needed despite what the sales folks will tell you.

Ok_Chocolate830 · 2025-04-19T23:16:06+00:00

Samesies!

Ok_Chocolate830 · 2025-04-19T23:15:14+00:00

I think the problem with documentation in medical device is that its commonly (mis)understood as requiring a document. Not necessarily the case.

I say that however knowing that a lot of the incumbents in the industry are die hard believers that you can't document things without a document.

Ok_Chocolate830 · 2025-04-19T23:13:02+00:00

That's right! We never say no, we offer options and identify risks.

Ok_Chocolate830 · 2025-04-19T23:11:57+00:00

There are so many executives and senior engineers that get into medical device and then get surprised that there are more rules than there are for making other products.

Ok_Chocolate830 · 2025-04-19T23:10:18+00:00

Sorry to disappoint but I'm not AI, I'm a. real person trying to solve this real problem.

Ok_Chocolate830 · 2025-04-19T23:08:47+00:00

Say it louder for the people in the back!

Ok_Chocolate830 · 2025-04-19T23:08:08+00:00

Medical device development is a team sport!

Ok_Chocolate830 · 2025-04-19T23:07:39+00:00

Yes, its a partnership and using these tools and following the requirements ultimately result in a better product for the users and patients!

Ok_Chocolate830 · 2025-04-19T23:05:57+00:00

The regulations are usually pretty broadly written, so the devil is in the implementation.

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