Choosing a Notified Body: What MedTech Founders Need to Know

If you’re building a medical device under the EU MDR, picking a Notified Body (NB) is one of the most consequential decisions you’ll make on your road to market. It’s not a procurement exercise you can knock out in an afternoon, and it’s not something you’ll easily undo. The NB you sign with today will likely be your conformity assessment partner for years - through your initial certification, your surveillance audits, and most of your subsequent product changes. 

So, before you fire off RFPs to every NB on the NANDO database, slow down. Here’s what actually matters when you’re choosing one, especially as an early-stage company. 

1. Treat it like a long-term relationship, because it is

Switching Notified Bodies later is painful. It’s not impossible, but it’s slow, expensive and disruptive. Contracts with a NB are typically agreed for several years; for a while you may find yourself managing two parallel relationships at once. The new Notified Body may have different requirements than the previous one, which can increase workloads and create additional complexity during the handover. Difficult to handle for a start-up. Most companies that switch say they wish they’d chosen better the first time around.

That means your selection criteria shouldn’t just be price and turnaround. Think about cultural fit, communication style, the people you’ll actually be working with and whether you can imagine talking to them for the next several years. If your gut says “this is going to be painful”, trust it.

2. Make sure they have the right MDN/MDA codes

This sounds basic, but it’s where a lot of founders trip up. Notified Bodies are designated to assess specific device categories, identified by MDN codes (for non-active devices) and MDA codes (for active devices), plus horizontal codes for special processes (like sterile devices).

Your device may map to several codes - and not every NB covers every combination. Before you go any further in conversations, confirm in writing that the NB is designated for all the codes your device requires. The NANDO database is your friend here (Nando Database). 

3. Demand a real timeline and budget — ideally with fixed timing

One of the most common founder complaints about NBs is unpredictability. You submit your technical documentation, then wait... and wait. And then get a question, address it, and wait again. Sometimes the process takes up to 24 months in total. For a startup with a runway, this is existential.

A good NB should be able to give you a realistic timeline and budget upfront, with milestones you can plan around. Some NBs now offer fixed-timing commitments — meaning they contractually agree to specific review windows. Ask about this. Ask how they handle delays on their side versus yours. Ask what their average end-to-end time has actually been for devices similar to yours. Vague answers are a warning sign.

4. Look for structured dialogue

You’re allowed to have a structured dialogue with your Notified Body before formal submission — essentially a series of conversations to align on what your technical documentation should contain, what evidence they’ll expect, and where your weak spots are.

Not every NB offers this, and the ones that do offer it to different degrees. For a start-up with an innovative product, structured dialogue can save you months. You find out what’s missing before you submit, rather than getting a non-conformity report two months in. Ask explicitly: “Do you offer structured dialogue, and what does it look like in practice?”

5. Ask about the Express Route (or equivalent fast-track programs)

Some Notified Bodies have introduced expedited assessment pathways — sometimes branded as “Express Route” or similar — designed to give predictable, accelerated review for manufacturers who come in well-prepared. The trade-off is usually higher upfront cost and stricter requirements on the quality of your submission, but for a startup racing to revenue, the time savings can be worth far more than the fee delta.

These programs vary by NB, so ask: Do you offer one? What are the eligibility criteria? What are realistic time savings? And crucially, what happens if my submission fails to qualify or is removed from the express track partway through?

6. You’re not limited to your home country

This is something a lot of founders miss: you can choose any Notified Body designated under MDR, anywhere in the EU. You don’t have to use a German NB just because you’re based in Germany (and for us in Switzerland – we don’t even have one anymore). A Dutch, Italian, or Swedish NB is just as valid and may offer better availability, pricing, or fit for your specific device.

Capacity is still tight across the EU under MDR, so widening your search geographically can shorten your timeline significantly. Language is rarely a barrier, most NBs work in English. The one thing to keep in mind: occasional in-person audits will be easier if the NB has an office or auditor pool near you, but this rarely outweighs the other factors.

A practical way to approach the selection

If you’re starting from zero, here’s a sensible order of operations:

• Shortlist three to five NBs based on whether they hold the right MDN/MDA codes for your device.

• Reach out for an initial conversation focused on timeline, budget transparency, structured dialogue, and any fast-track programs.

• Ask for references from companies of similar size and device class.

• Then, if possible, meet the people you’d actually be working with, not just the sales contact. The reviewers and project managers are who you’ll spend the next several years with.
  

Choosing a Notified Body isn’t glamorous work, and it’s tempting to optimise for whoever responds fastest or, as a start-up, for costs. Resist that. A few extra weeks spent choosing well will save you months - and a lot of grief - later on.

As a start-up coach in medtech and with expertise in regulatory affairs, I’m frequently asked the same questions. So, I'm turning the most common ones into a series of posts.    What’s your burning question at the moment? Let me know... it might become the next post! Nila