Formly
Formly Regulatory Pathways

MDR pathway & Notified Body match program

Getting a device through EU MDR comes down to two decisions most founders get wrong before they've written a word: the pathway and the Notified Body. We'll get both right with you, then sit in on your first Notified Body call. And we’re offering the program to three founders a month, at no cost.

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About the program

Three steps to a confident EU entry

As part of our ongoing commitment to getting medtech founders to market by the shortest path, we're opening three spots a month to start founders off right on their EU MDR journey.

We'll work with you on your pathway, match the right Notified Body, and join your first call, the three early decisions that shape everything after.

No forms to wrestle with, no long onboarding. You apply, we do the thinking, and within a couple of weeks you have a clear EU MDR route, the right Notified Body lined up, and a senior regulatory lead beside you for the first call. Here's how it runs.

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  1. Pathway Assessment.

    Tell us about your device and your target markets in a short application. We review it internally, then spend 30 minutes with you confirming your MDR route and flagging the risks worth knowing now. You leave with a one-page pathway summary you can act on and come back to.

  2. Notified Body Match.

    This is the step that moves the needle most. We match you to the Notified Body that actually fits your device, weighing product category, software and AI complexity, capacity, and your timeline. The right choice can save you a year, and we'll show you exactly why your match is the right one.

  3. Notified Body Intro Meeting.

    We arrange and co-attend your first scoping call with the Notified Body. Having a senior regulatory lead in the room tells them you're serious and gives them confidence in your submission, so the conversation starts from credibility rather than from scratch.

The hardest part of MDR happens before the paperwork does

Most founders lose months to decisions they didn't know were decisions. Here's where it tends to go wrong.

You guess the pathway.

Classification, conformity route, and evidence requirements shift with every device. Read it wrong early and you end up rebuilding the whole submission later, on runway you can't spare.

You pick a Notified Body blind.

Not all Notified Bodies are alike. Capacity, queue times, and how well they understand software and AI vary enormously, and the wrong fit can add a year to your timeline. Most founders don't realise this is even a choice they're making.

You walk in alone.

Your first Notified Body call sets the tone for everything after it. Go in without someone who has done this before and you spend the meeting learning the rules instead of making progress.
That’s why we created the MDR pathway & Notified Body match program

Apply for the program

Complete a short application form, and eligible startups will be invited to join the MDR pathway & Notified Body match program. We take three founders a month and review applications in the order they arrive. Once the month's spots are full, applicants join the waiting list. It costs nothing but the time it takes to apply.

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Regulatory certainty when it counts

Trusted by some of the most complex device companies across markets.

Thank God we found Formly. They saved us 3-5 years by giving us the right advice and sparing us from having to navigate it all ourselves. They are true partners, not vendors. We truly feel they are here with us.

Christiaan FultonChromacare
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