MDR Class I: Everything You Need To Know

We’ve posted a lot of stuff on MDR Class I in the past, and this article is my attempt to synthesise all that content into one short, sweet article for you. So that you don’t have to experience the pain we feel in our daily consulting when customers come to us with MDR class I questions (ugh)! So let’s get started.

First off, what the hell is MDR class I?

MDR Class I Definition

A product can be class I under the MDR if it does not fulfil most parts of MDR rule 11. I’ve simplified all the legal-speak here and condensed the rule 11 here for you. A product can be MDR class I if it:

  • Doesn’t provide information which is used to take decisions with diagnosis (<– note the typo in the MDR) or therapeutic purposes.
  • Is not intended to monitor physiological processes.

The actual rule 11 in the MDR (search for “rule 11” on the crappy EU page) is more lengthy, but this is what it boils down to.

As you might notice, the above definition still leaves a little bit of room for interpretation. That “little bit” is so huge that we could probably earn multiple year’s worth of consultant salaries from just consulting clients on this crappy class I topic. And all of that just because some un-smart regulator wrote a very broken rule 11 and didn’t even check for typos. Unbelievable.

Sometimes I wonder what we’d do if the MDR didn’t exist. Maybe I would set up IKEA furniture for a living and contribute to society in a constructive manner, in contrast to regulatory consulting.

Anyway, onwards! What’s the main problem with MDR class I?

The MDR Class I Problem(s)

The main problem of the MDR class I situation boils down to all humans on this planet disagreeing on what “provide information which is used to take decisions with diagnosis (<– note the typo, again) or therapeutic purposes” actually means.

So what are examples of MDR class I medical devices with this problem?

MDR Class I Example Devices

Assume you build a “diary app” in which a patient logs how they feel every day. Is this already information for diagnostic and therapeutic purposes? Probably not, because a patient can’t make a diagnosis or initiate a therapy, but a physician can. But what if a physician looks at the app diary, too? It’s a huge grey area and the current (broken) interpretation is that the app would become class IIa if it includes some sort of “dashboard” feature for physicians. Otherwise it’d be class I.

(People say the best regulation is simple. By that logic, the MDR is not the best regulation.)

Another example: Assume you build a self-guided “depression course” app in which the app walks users through a course on depression. You could argue it doesn’t provide information for diagnostic and therapeutic purposes because, well, it is already delivering therapy directly. This is what some manufacturers do. It sounds just as broken and contorted as what you’re probably thinking right now, I know.

I’ve written a more lengthy summary of the class I situation with real-life examples of MDR class I devices in this post: The MDR Class I Software Situation (brace for pain). As a side note, some telemedicine companies claim their software to be class I, and that’s false – Telemedicine software is not a medical device, as I’ve written here. Additionally, here are some more examples for MDR class I devices.

How Do You Bring a Class I Device To Market?

This is where most founders screw up, because they become irrational.

The #1 rule for bringing a medical device to market is choosing a country or state which interprets MDR class I the same way you do. Most other things simply don’t matter. Some background first!

As a MDR class I manufacturer, you don’t need to go through a prior audit before bringing your device to market. Wait, what? Here’s how class I and class IIa and higher differ:

  • For a MDR class I device, you simply create the proper documentation, add the CE label to your device yourself and bring it to market. No auditor necessary. Needless to say, this saves you time and money.
  • For a MDR class IIa or highger device, you need a prior audit by an auditor before bringing it to market. This costs more time and money.

Here are more articles on how long it takes and how much it costs to bring a medical device to market.

But! Here’s the big but: As a class I manufacturer, you’re still subject to surprise audits by the local so-called “competent authority”. In other words, they can send you a letter and demand an in-person audit, and if they think your device is actually class IIa and not class I, then you might have to take it off the market.

Now, which competent authorities exist and how do they interpret things? In Germany, each state has its own competent authority. So if your company is located in Berlin, you’re dealing with the Berlin competent authority. From experience, we know that they generally don’t agree with any software being class I under the MDR. So, if you’re founding a startup in Berlin, you should open a branch in Hamburg or Munich and bring your class I device to market there.

Here’s a list of competent authorities for which we’ve heard they allow MDR class I devices:

  • Hamburg, Germany
  • Bavaria, Germany
  • Denmark

And here’s a list of competent authorities for which we’ve heard that they don’t allow MDR class I devices:

  • Berlin, Germany

For all other countries, as a rule of thumb, I’d say that if a country is rather “entrepreneur-friendly”, chances are good that it accepts MDR class I. Estonia comes to mind. But I don’t have data there.

But here’s the trap: For some reason, I’ve come across multiple founders based in Berlin who think that they can “convince” the Berlin authorities that their device is MDR class I. The answer is no. Those people already have made up their minds. No written consultant opinion will change that, even if you purchase a (uselessly) expensive one from a lawyer.

So. Just leave Berlin and move on. Build your product.

Related articles:

How Much Does It Cost And How Long Does It Take?

Looking at only the regulatory documentation effort, it takes 2-3 months if you do it in a lean way (with our templates, with our eQMS and optionally with our consulting). If you choose other consultants with their clunky templates, I’ve seen other startups easily take 12+ months. More on this topic.

The cost is free if you do it yourself (our templates are free, too!). Other options are our self-guided Wizard for a one-time fee (currently 3k€), or our consulting for 20k€ upwards. Other consultants and video course tend to cost much, much more (50k€+). But I’m not trying to sell you anything here. Do it yourself, that’s the best. More on this topic.

Can We Get An Official Classification Decision For Our Device?

The short answer is no.

The long answer is that the BfArM in Germany offers this service, but turnaround times there are so terrible that it’s not viable for a startup. Or any business which operates in the real world on this planet, really. It easily takes more than one year to get a decision. We did it once, so we have first-hand experience here. Don’t do it.

And even if you do it, the BfArM tends to be rather conservative in its classification decisions. That means that your device will likely be classified as class IIa or higher anyway, and then you’re screwed, too.

Your other options are purchasing a written assessment from a consultant like us. Frankly, those are not very useful. Sure, you could show them to your competent authority when you’re audited, but that would require your competent authority to be open to a rational discussion (which excludes Berlin). I’ve heard that’s the case in Denmark, so it might make sense there.

Conclusion: MDR Class I Walkthrough

Bringing a MDR Class I device to market is actually a pretty cool opportunity for a startup, because overhead is still reasonably low (you don’t need an audit). So, if your device qualifies for being a class I device, I suggest you give it a go!

Just don’t do it in Berlin.

On a different note: Do you still have lots of questions about the EU MDR and would you like to talk to a human? No worries! We offer our Regulatory Strategy Workshop to companies like yours, in which we sit down with you for two hours, answer all your questions and come up with a plan with which you’ll bring your product to market. For only 400€!

Or, if you don’t like talking to humans, check out our Wizard instead. It’s a self-guided video course which helps you create your documentation all by yourself. No prior knowledge required.

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

And finally, if all of this doesn’t sound helpful and your situation seems hopeless, check out our consulting 🙂

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  • Please keep in mind, that even with a class I device, your obligation to create a QMS, technical documentation and clinical evaluation are exactly the same as with a.e. a class IIa device. Costs and time are not only on the notified buddy (hehe) side, often consulting services are much more expensive (clinical evaluation 60 kEur+). And you need a good clinical evaluation for a class I device if you don’t want to catastrophicly fail when the competent authority comes for a visit!

    I always recommend to have at least a 13485 by a certification body, as it will tell you if your processes are good enough to create the product documentation you need.

    • A

      Hey Martin, nice hearing from you here 🙂

      Those are some great points! I’ve seen some truly terrible (or even non-existent) clinical evaluations while consulting manufacturers of class I devices.

      I suppose it boils down to how many risks a company wants to take: You could either not go through a 13485 certification, with the potential huge risk of having a catastrophic surprise audit by a competent authority, or you could opt for a 13485 certification and minimise your risks significantly.

      Nowadays, with notified body wait times going down again (which is great), this might be a viable option for more companies. That being said, there’s still quite a lot of confusion about the differences between “only” an 13485 audit and a “full” MDR audit. I’ll try to write up something about that in the future!

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