How Much Does Medical Device Compliance Cost?

Dr. Oliver Eidel
Updated May 27, 2024


We're a startup and are considering bringing a medical device to market. How much does it cost?

Short Answer

MDR class I: Free, if you do it yourself (recommended).

MDR class IIa and higher: At least 30k€, probably 50k€.

Both figures increase if you hire consultants (maybe) or buy templates (don’t do this).

Long Answer

This is probably the second-most-asked question after “How Long Does It Take?”. And, similar to my answer to that question, it depends on your MDR class, whether you buy templates (don’t do this) and which consultants you hire, if any (let’s discuss that below).

Cost Of Medical Device Compliance Templates

Templates first! In short, just use our templates. There’s literally no rational reason to use other templates. Our templates are 100% free, they’ve passed audits, and they’re much shorter than other templates which easily translates to a ~9x efficiency gain because you spend less time reading and filling out templates.

If you are still not convinced, I’ll copy-paste a comparison table from my other article here:

Template TypeTotal Page CountCostPasses Audits
OpenRegulatory Templates1xFreeYes
Other Consultants Templates~9x of OpenRegulatory Templatesx,xxx €Yes

Again, if you choose other templates, I won’t hold your hand when your startup goes bankrupt due to running out of time and money.

Cost Of Notified Bodies (Depending On MDR Class)

The next and probably most important cost is that of your Notified Body. Let’s see first whether you need one. If you’re MDR class I, you don’t need one. If you’re MDR class IIa or higher, you do need one. It’s that simple.

Notified Body prices typically range from 30-50k€ for startups bringing their first medical device to market. I wrote a separate article about more “premium” Notified Bodies with even higher prices, but I wouldn’t recommend them right now.

Cost Of Regulatory Consultants

First off, let me tell you that you don’t need a regulatory consultant. With our OpenRegulatory website, you’ll hopefully have everything you need for free – just read our articles and use our free templates, it’s as easy as that.

Still, there is some benefit to be gained from hiring consultants. You’ll likely be much faster (at least if you hire us), and you have someone who reviews your documents and answers your questions.

That being said, there are huge price and efficiency differences between consultants. Let’s look at another table.

Consultant TypeBillingTypical Total CostWhen Do You PayTypical Total Duration
OpenRegulatoryFixed-price50-70k€Only when documents get done2-4 months
Other ConsultantsBy the hour100-150k€Every month, regardless of progress 12+ months

As far as I know, we’re the only consultants who do fixed-price offers where you only pay when progress happens (= documents get done). Also, we’re around 3-4x faster than other consultants. Check out our consulting page if you’re interested.

If you think only crazy people choose other consultants, I’ve got surprising news for you: Interestingly, many founders still choose other consultants. I don’t know why. Maybe they promise more or exaggerate in their marketing. Most of those founders end up being very unhappy. It’s a shady industry.

Anyway, your consultants will be a significant expense if you choose to hire them.

QMS Software

A bit of a side note, for very good reasons. In addition to templates, you can also purchase QMS software (and we offer our own). As a first-time medical device startup founder, I’d suggest though to postpone this decision until later, because you first should learn what you need to document before you get into how you can document that more efficiently. More details here.

Conclusion: Cost Of Regulatory Compliance

So what would I do? First, I’d obviously go with the OpenRegulatory templates because they’ve passed audits, they’re short, and they’re free. Then, if I’d be class IIa or higher I’d go with a Notified Body which is not completely incompetent when it comes to software and startups (article here) for 30-50k€. And finally, I’d first try to have someone from my team draft the documentation first (or do it myself) and only then hire consultants if we can’t get it done.

And finally, once I’d have understood the regulatory documentation stuff sufficiently, I’d go and look for QMS software to automate the painful parts. Of course I’d choose Formwork, not only because it’s the most awesome (it is), but because it’s the only software on the market with unlimited users, transparent pricing, data export and startup-friendly prices starting at 49€ / month.

Good luck with your startup! 🙂

On a slighty different note: You want to get your medical software certified under MDR but don’t know where to start? No worries! That’s why we built the Wizard. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.


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