Europe Just Threw Down the Gauntlet on Regulatory Submissions

Why are we building AI-powered devices but still tracking regulatory changes in spreadsheets?

If that hits a nerve, you’re not alone. Most medical device companies, even the most cutting-edge ones, are still managing their regulatory documentation like it’s 1993. Word files sent back and forth over emails, multiple versions that need to be consolidated manually. Manual updates that cascade into days of rework. Minor tweaks that force full-blown submission rewrites across a number of documents. It’s painful. And it’s holding innovation back.

Now, one of the biggest advocates of Medical Device regulatory policy in Europe is calling for innovation to do something about it.

MedTech Europe, one of the most influential industry groups shaping EU device policy, just issued a position paper calling for a radical shift in how technical documentation is created, maintained, and submitted. They’re not asking for another round of template updates. They’re calling for something smarter. Modular. Digital. Scalable. Reusable.

In other words: a future where regulatory submissions are actually built to keep up with the pace of innovation.

And no, this isn’t just European theory. It’s a wake-up call. Because while global regulatory bodies haven’t made this kind of push yet, the pain points MedTech Europe is trying to solve? The global Medical Device innovators know them all too well.

The future of regulatory submissions is being built right now. And you don’t want to be the last one duct-taping documents together or scrambling to update your legacy systems when the rest of the world finally catches up.

Why This Matters to You — Even If You’re not in Europe

MedTech Europe is the industry association representing medical technology companies across Europe — think diagnostics, devices, digital health, the whole spectrum. When they release a position paper, it’s not just academic hand-waving. It’s a signal. A coordinated call for regulators and companies to move toward smarter, more scalable systems.

And here’s the thing, the core frustrations they’re trying to solve? U.S. companies feel them just as deeply. Maybe more.

We’re talking about bloated Word documents that live on someone’s desktop. Version control nightmares where you’re never quite sure which file is the “real” one. Audit prep that turns into an all-hands fire drill. And the kicker? A minor change to a design or document that means reworking your entire technical file for regulatory submissions.

If you’re in a startup or running lean with a small regulatory team, this chaos hits harder. Every update, every iteration, every submission. It’s a time suck. And it’s not sustainable when you’re building fast, launching globally, and wearing multiple hats.

The rest of the world hasn’t officially called for a smarter, modular approach to regulatory content yet. But if you think that day isn’t coming, you’re betting against the direction the entire industry is headed.

So what do you do? You get ahead of it. You design your systems now to be flexible, digital, and scalable. You stop treating submission prep like a final exam and start treating it like an evolving, manageable process. Because when the global regulators do catch up, and they will, the companies who’ve already made the shift? They’ll be miles ahead.

What MedTech Europe Is Actually Asking For (And Why It’s a Game-Changer)

Let’s break this down, because if you skimmed the MedTech Europe paper, you might’ve missed just how bold (and frankly refreshing) their vision really is.

They’re not just suggesting we tidy up our templates or move from Word to a digital document management system. They’re pushing for a complete overhaul in how medical device development content is created, managed, and reused.

Here’s what they’re really calling for and what it could mean for your team:

1. Modular, Component-Based Content
Forget documents. Think LEGO bricks. Each chunk of regulatory content, like your indications for use, device description, individual design inputs, or test case, lives as its own reusable block. When something changes, you update one block and boom, it updates everywhere it appears in your documents. No more manually reworking an entire DHF for a change to your device description.

2. Version Control at the Content Level
Instead of versioning entire documents, you version individual components. That means no more hunting through folders to find “Final-Final-V3_Updated_USETHISONE.docx.”.  Updates are made in the system live and the impacts to other content are flagged for review.

3. Smart Document Regeneration
Make a change to a piece of content, and your documents update automatically. The system pulls in the most current, approved content blocks and assembles them into the right format, every time. No manual copy-pasting. No missed updates. No surprises on audit day.

4. Machine-Readable Formats
Documents that aren’t just readable to humans, but also to machines. That opens the door for automation, advanced analytics, and easier integration with other tools. Think JSON, XML — the stuff that lets systems talk to each other without translators.  We seek to work with MedTech Europe and other global regulators to make automated submissions and change notifications a reality. 

5. Tools That Work for Everyone, Not Just Big MedTech
Perhaps the most refreshing part? They emphasize that these solutions must work for small companies, too. Startups. SaMD teams. The folks moving fast with lean resources. Because let’s be honest, these are the teams getting crushed by the old way of doing things.

This isn’t about fancier templates. It’s about escaping the content chaos that’s been holding Medtech back for decades.

And if it sounds futuristic, it’s not. It’s already happening because at Fission, we are making it happen.

How Fission’s Already Doing This, And Why That’s a Big Deal

While MedTech Europe is calling for this digital shift, Fission’s already built it.

Not in theory. Not on a roadmap. It’s here.

Let’s walk through how our platform lines up, piece-by-piece, with the vision they laid out:

Modular Content → Your Core Content Blocks
We ditched the document-first mindset. In Fission, everything is structured around data or reusable, modular content blocks. Each block, like your device description, intended use, or risk summary, lives independently but links wherever it’s needed. One update, infinite consistency.

Version Control → Built-In, Granular, and Traceable
No more guessing which file is the right one. Every content block in Fission has its own version history, complete with approvals, timestamps, and author tracking. It’s audit-ready by design.

Auto-Generation → Your Submission, Updated in Minutes
Change a piece of content and regenerate regulatory submissions in just a few clicks. Whether it’s a document for a 510(k), De Novo, or Technical File, you always know you’re working from the most up-to-date, accurate content.

Future Formats → Ready for XML, JSON, and Beyond
We’re already architected for the future. We are actively working with  regulatory bodies as they shift toward machine-readable formats. You won’t be left copying from Word files into databases when the industry moves forward.

Usability → Built for Startups, Not Just Giants
Most platforms are built for global enterprises with dedicated regulatory ops and document management teams, even solutions that purport to support startups require dedicated resources to manage the platform. Ours is built for the reality we see every day: scrappy teams juggling quality, engineering, and submissions. It’s intuitive, scalable, and doesn’t require a 10-week onboarding course to use.

The bottom line? This isn’t a wishlist. It’s already working, right now, for companies who are tired of wrestling Word docs and living in spreadsheet purgatory.

The Bigger Shift: From Documents to Living Regulatory Ecosystems

Yes, some teams are still wrangling Word docs, spreadsheets, and shared drives. But others have already moved to digital tools. Maybe you’re using a traditional eQMS or a document management system that helps you check your regulatory boxes.

Even these modern QMS tools weren’t built for the type of regulatory content lifecycle MedTech Europe is calling for.

They digitized the filing cabinet, but they didn’t rethink the filing system. They’re still document-based at the core. Still linear. Still dependent on people manually updating content in multiple places when something changes.  Companies pay thousands in annual fees for these systems and still need to hire document management specialists to run them and ensure that changes are applied across all impacted files in preparation for regulatory submissions.

That’s not transformation. That’s an expensive  way to keep doing things the old way.

What we’re talking about here is different. This is a shift away from static documents and toward modular, dynamic content systems. Systems that are built to flex with your product, not break every time something changes.

Because regulatory content isn’t static. It evolves with every product tweak, every market expansion, every labeling update. Managing that through rigid documents, even digital ones, just doesn’t scale.

It’s time to stop thinking in terms of documents and start thinking in terms of content ecosystems.

Yes, it’s a mindset shift. Yes, it might challenge the way your team has always worked. But it’s also a huge opportunity to move faster, operate with more confidence, and scale smarter.

And make no mistake, the shift is already happening. Europe is pushing for it. The rest of the world won’t be far behind.

You can wait until it’s mandatory… or you can start building a system that actually works for you today.

Don’t Wait for the regulators to Demand It

Here’s the truth: no one’s going to send you a memo saying it’s time to overhaul how you manage content for regulatory submissions.

Not the FDA. Not your notified body. Not your QMS vendor.

But if you’ve ever sat through a design review and realized your regulatory docs are the wrong version, already out of date, or scrambled to prepare a submission only to find conflicting versions of the same information, then you already know something’s got to change.

MedTech Europe just put that truth into writing. They’re calling for a smarter, modular, digital approach to tech documentation, one that matches the pace of modern innovation.

You don’t have to wait for the rest of the world to say the same thing. You can build it now.

This isn’t just about compliance. It’s about competitiveness. It’s about using a system that actually supports your speed, your quality, and your ability to scale and is as innovative as your technology is.

The duct tape-and-Word-doc era is ending. And that’s a good thing.

So here’s the invitation: be part of the shift. Ditch the chaos. Ditch the rework. Start building a regulatory content system that evolves with your product, not against it.

We’re already doing it at Fission, and we’d love to show you how.

Ready to future-proof your regulatory systems? Let’s talk.