I’m building a tool to make MDR Annex II documentation less chaotic

I didn’t start with the idea of building a startup.

I started with a pattern I kept seeing:
small EU medtech teams struggling with MDR Annex II, not because they don’t understand the regulation, but because the documentation process itself is fragmented, inconsistent, and stressful.

Annex II isn’t one document.
It’s a structured story spread across device descriptions, risk references, verification summaries, GSPR tables, and clinical evidence. In practice, that story often lives across folders, Word files, Excel sheets, consultant comments, and half-finished templates.

What I kept seeing:

• Teams staring at a blank Annex II template, unsure where to start

• Overdocumentation “just in case”

• Inconsistencies between sections that create notified body questions

• Knowledge stuck in people’s heads instead of in the structure

That’s the problem I’m trying to address.

What I’m building (and what I’m not)

I’m building a small web app that helps teams structure and draft MDR Annex II technical documentation step by step.

It is not:

• a QMS

• an automated compliance tool

• a replacement for regulatory responsibility or consultants

The goal is much simpler:
reduce blank-page stress, enforce structure, and improve consistency across Annex II sections.

Think of it as a guided workspace that helps you say the right things in the right place, while still requiring human judgment and accountability.

Why I think this matters

From what I’ve seen, notified body feedback is often not about missing tests or wrong standards, but about:

• unclear intended purpose wording

• weak linkage between risk, benefit, and performance

• inconsistent terminology

• unclear justification narratives

These are structural and narrative problems, not scientific ones.

If better structure alone can reduce back-and-forth with NBs, that’s already a win.

Where I am right now

This is very early.

• The concept is defined

• Annex II is mapped section by section

• I’m validating whether the pain is real enough to justify a dedicated tool

Before going further, I want input from people who actually work with MDR.

What I’d love feedback on

If you work in regulatory affairs, quality, or as a PRRC or consultant, I’d love to hear:

• Which Annex II sections cause you the most friction in practice?

• Where do you see teams consistently over- or under-document?

• What would you never trust a tool to help with?

• What would make you say “this might actually save time”?

No pitching, no links, just learning.

If this resonates, feel free to comment or DM.
I’ll share what I learn as I go.