Picking Your Notified Body: The Decision That Can Wreck Your Whole Timeline

Let's start simple. If you want to sell a medical device in Europe, and it is above level 1 in MDR, (has an intended use, with a real potential risk, if it doesn't work as planned), you need to have it approved by the EU. The EU has outsourced this authorization to organisations, called a Notified Body. They check your device and confirm it's safe and follows the rules. Once they say yes, you get to put a CE mark on it. That's the stamp that means "this is legal to sell in Europe." 

Picking which Notified Body to work with might sound boring or trivial.  But it's actually a huge decision. It can decide whether you're even allowed to sell your device in Europe. And how long you'll be stuck waiting to find out. We have seen adult men, almost cry, because they chose the wrong notified body. 

Here's what usually happens, especially if this is your first time doing anything like this. 

You're busy. You're doing ten jobs at once. And suddenly there's a deadline coming up for this Notified Body thing that you barely understand yet. So you do what feels natural: you go with whichever company replies to your email first. It feels like progress, and progress feels good when everything else is chaos. 

You also don't think to ask hard questions before signing, like how busy they are, or whether they can actually handle your specific type of device. Those questions don't even occur to you yet, because nobody warned you they mattered. 

None of this is a mistake, exactly. You're not being careless. You're just new to this, moving fast, and trying to check a box so you can get back to building your product. But these small decisions add up quietly in the background. And by the time you notice a problem, you're already stuck. At that point, no amount of money or hustle can speed things back up. 

A few more things you should know. Not every Notified Body can check every kind of device. Some only handle certain product types. And many of them have stopped taking new clients, because they already have too much work. Right now, a review usually takes 13 to 18 months. That's more than a year of waiting. 

Based on our experience speaking to +100 companies and experts, we encourage you to: 

1. Do due-diligence. Ask your incubator, accelerator, friends, other startups for which Notified bodies they used, and what their experience was like. 
2. Identify 2-3 Notified bodies, that come recommended from your network and are authorized and experienced for your device type. 
3. Take a meeting with 2-3 Notified Bodies – show them your regulatory classification, your intended usage and get them to confirm your risk class (Health Tech Pathways provides the necessary documentation very easily). Notified Bodies does not always evaluate the risk class the same, as it is not an exact science. Also get them to confirm in writing, when they have time for you, how they will engage with you throughout the process. Also ask if you can meet the delivery team (and not only the sales team of the Notified Body), to make sure you have met the ones you are going to work with for +6 months. Ask for the formats they required. And make sure,that the switching costs of switching Notified Body are not too high, if you for some reason decides mid way you need to switch. We hear from many that they had wanted to switch, but it was too expensive mid way to switch. 
4. Find a consultant that can assist you in the process – ideally someone who has also worked with the notified body you decide on. (see blog post on finding the right consultant). 
5. Choose the right tools, and build your internal team, culture and competencies. Getting CE mark is not only about the right Notified Body, but also about using tools, such as Health Tech Pathways, that can prepare you better for your process with the Notified Body. 

If you have other must do's to chose the best Notified Body – please let us know, and we will pass on the knowledge to our community.