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).

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).

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:

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.

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.

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.

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.

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.

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! 🙂