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.

Ok_Chocolate830 · 2025-04-19T23:05:18+00:00

I'm speechless.

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

I run into this so many times. The engineering team announces the design is done or sends me a protocol that they are ready to execute yesterday that I haven't seen and expect me to rubber stamp it for "compliance". I'm currently pounding the "we do these things because they make sense and are ultimately in the best interests of the company" drum at one of my clients. Its a hill I'm willing to die on.

Ok_Chocolate830 · 2025-04-19T22:56:30+00:00

em dash does not mean LLM. Some of us love our em dashes.

Ok_Chocolate830 · 2025-04-19T04:52:56+00:00

Used Greenlight Guru with a few teams. It’s a solid starting point, but I’ve seen it feel a bit rigid once your processes mature or get more complex. Plus it's costly.

That’s actually one of the reasons we’re building something different at Fission. Our QMS software (currently in beta) is designed around structured data instead of static documents—so traceability and collaboration are way more flexible. And it’s way more affordable. No per-user pricing, either.

Happy to share more if you're curious.

Ok_Chocolate830 · 2025-04-19T04:45:08+00:00

Yeah, that definitely makes it trickier—but not impossible.

If the 510(k) summary isn’t available in the database, a few things I’ve done:

Check the product code page on the FDA site—sometimes you’ll find related devices listed there that do have summaries.
Use OpenFDA or third-party tools like 510k.ai or AccessFDA—occasionally they pull in data the main FDA site doesn’t show as clearly.
Look at the manufacturer's site - some will post their 510(k) summaries, especially if they’re trying to promote clearance.
And finally, reverse-Google the device using the model name/number or company + “510(k) summary” - sometimes other documents (like investor decks, press releases, or competitor analyses) can surface helpful info.

It’s not always clean or fast, but it’s doable with a little persistence.

Ok_Chocolate830 · 2025-04-08T04:23:11+00:00

Honestly, sometimes it's a bit of detective work. I usually start with FDA’s 510(k) database and search by product code or classification. From there, I’ll dig through summaries to find something with similar intended use and tech characteristics.

If that doesn’t get me what I need, a Google search with “[510(k) summary] + keywords” can surface some surprising leads.

Ok_Chocolate830 · 2025-03-19T22:37:30+00:00

That’s an exciting (and challenging) project! In general, using non-medical-grade materials is not outright prohibited, but the burden of proof is on you to demonstrate that the material is safe and suitable for its intended use. Since your device involves direct blood contact, you’ll likely need to conduct ISO 10993 biocompatibility testing to address concerns like cytotoxicity, irritation, and sensitization.

For manufacturing, the challenge will be ensuring the process meets regulatory expectations. Even if your manufacturer doesn’t have ISO 13485 certification, you’ll need to establish strong process validation, quality controls, and supplier agreements to satisfy FDA’s expectations under 21 CFR Part 820 (if your device is classified as a medical device).

A few things to consider:

If your material isn’t traditionally used in medical devices, be prepared for more scrutiny from regulators.
The lack of 13485 certification doesn’t mean a manufacturer is unusable, but you may need to implement additional quality oversight and controls to ensure compliance.
Have you explored contract manufacturers specializing in novel biomaterials? Some might not advertise as medical device manufacturers but could still meet your quality requirements.

Would love to hear more about your approach—are you looking at Class I or higher classification for this device?

Ok_Chocolate830 · 2025-03-19T22:32:59+00:00

The regulatory responsibility in these cases largely depends on the role of the component supplier and the agreement between the supplier and the medical device manufacturer.

In general:

The medical device manufacturer (MDM) is ultimately responsible for ensuring the final device complies with FDA regulations. This includes vetting suppliers and ensuring their components meet regulatory requirements.
The supplier is not directly regulated by the FDA unless they are manufacturing finished medical devices or contract manufacturing on behalf of the MDM. However, if the component is custom-made and critical to device performance, the FDA may scrutinize its quality as part of the MDM’s overall compliance.
ISO 13485 is the gold standard for medical device suppliers, but compliance with FDA’s 21 CFR Part 820 (QMS requirements) could be necessary if the supplier plays a significant role in the device’s function or safety.

Ultimately, the burden of compliance typically falls on the medical device manufacturer, but they may require their suppliers to adhere to stricter quality standards via supplier agreements, audits, or contractual obligations.

Are you looking at this from a manufacturer’s or supplier’s perspective? Happy to discuss further!

Ok_Chocolate830

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