The Notified Body vs. FDA: What Europe Does Differently

This transcript was generated using AI and edited for clarity. Deviations from the spoken word are possible.

[00:00] Voice:
Welcome to MedTech Unfiltered, the Corscience Podcast where we talk about the real challenges of developing and improving complex medical devices.

[00:14] Andras:
Dear viewers and listeners, welcome back to the Corscience Podcast. Today I have decorated Army veteran Paul Griffin with me — my colleague, and honestly a genius when it comes to QA. Paul, can you tell us a bit about your background? How did you come to Corscience, and how did you end up in Germany?

[00:41] Paul:
Thank you, Andras, for inviting me onto the Corscience show. My whole life story would probably take more than one podcast episode. After several years serving in the US Army as an engineer, I decided it was time to begin a new chapter. I didn’t transition directly into quality management or the medical device field — I was fortunate to find the right opportunity at the right moment, and that turned out to be in Germany, not the US. Since being here, I’ve been welcomed with open arms, and Corscience’s culture fits my personality really well. I get to do what I love.

[01:30] Andras:
And that’s why I’m here — I love working with you, and I think it really does fit your personality. You’re a great example of what it means to bridge two cultures. Thank you for your service, and thanks for being here today. So — today I want to talk about Notified Bodies: what it looks like for a company that’s used to the FDA and is now looking into transitioning or acquiring MDR certification. What is a Notified Body?

[02:20] Paul:
Great question. It’s sometimes confusing — but if you’re a US startup or medical device manufacturer, you’ve probably heard the term “Notified Body,” and if you’ve ever thought “what the heck is that,” congratulations, you’re completely normal. Over the next 15 to 20 minutes I’ll walk you through what a Notified Body is, why it plays such a central role in European regulation, why it often confuses American companies, and how to prepare for that stage of the CE marking journey.

[03:05] Andras:
Okay, let’s get straight to the heart of it.

[03:12] Paul:
Sure — let’s keep it simple. They’re called Notified Bodies because the national authority — for example, in Germany, the Netherlands, or Ireland — notifies the European Commission that the organization is qualified to perform assessments under the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR). Notified Bodies are independent, licensed and monitored by an EU member state, authorized for specific device types, and essential for most devices above Class I.

[03:59] Andras:
So to summarize: independent, licensed, and monitored by an EU member state.

[04:16] Paul:
Exactly. Think of them as independent auditors — FDA reviewers and European bureaucracy wrapped up in a polite way. As you move through the CE marking process, your Notified Body evaluates the fundamental requirements relevant to your device and your quality management system — usually ISO 13485 in our case at Corscience. They run audits, including unannounced ones, to make sure your processes actually work. They also check your technical documentation — everything that proves your device is safe, functional, and meets European requirements: risk management, design history, verification, validation.

[05:19] Andras:
So why do companies — especially American ones — struggle to find their way around this system?

[05:33] Paul:
Good question. In the US, there’s only one authority calling the shots: the FDA. They review your device, check your documentation, inspect your quality systems, and ultimately decide whether you can sell your product. It’s centralized.

[05:55] Andras:
And in Europe?

[06:03] Paul:
Europe said: let’s do something different.

[06:08] Andras:
Europe finally does something different!

[06:12] Paul:
Exactly — they outsourced it. Instead of an FDA-style agency, Europe works with independent organizations called Notified Bodies, who perform conformity assessments and decide if your device meets EU regulation.

[06:42] Andras:
Can you just select any Notified Body? Is it one-size-fits-all, or specific to your product?

[06:47] Paul:
You have to be specific about the class of medical device you have, because that dictates which Notified Body you need — anything above Class I requires one.

[07:17] Andras:
So once I’ve found a Notified Body that fits my device class, is that all I need to know?

[07:17] Paul:
There are a couple more steps. Notified Bodies are market-driven — Europe wanted flexibility, specialization, multiple assessment bodies, competition, efficiency, and independence from central — even political — influence in the decision-making process.

[08:02] Andras:
Why does it work that way? How did it evolve?

[08:08] Paul:
In the pre-MDR days, there were a lot more Notified Bodies — I’ve read it was around 80 at one point. After MDR came into force, it raised the bar significantly: stricter oversight, more requirements, more scrutiny. As a result, many Notified Bodies simply couldn’t meet the new standards, and the number dropped dramatically.

[08:38] Andras:
So, Paul — on what basis do I choose the right one?

[08:38] Paul:
If you’re a startup or medical device manufacturer in the EU, choosing your Notified Body is one of the most important decisions you’ll make — because it’s not a vendor relationship, it’s a partnership. Here’s what matters most: check their scope and certification — is it right for your type of device? Check their designation. And naturally, timelines and capacity — they could be booked out for months, so plan accordingly.

[09:14] Andras:
Does that happen often — being booked out for months?

[09:19] Paul:
It depends on their workload, so I can’t generalize. It’s like a free market — it can happen, so plan for it.

[09:38] Andras:
Does communication style matter too?

[09:44] Paul:
Some are friendly and responsive, others feel more like a government agency from decades ago. That naturally affects the price too, so factor that into your budget — and think about how your own organization communicates. You want to be able to speak the same language, so to say. I’d also look for experience with startups — a Notified Body that doesn’t panic when your quality system is still evolving. They shouldn’t hold your hand, but they should speak your language.

[10:39] Andras:
What about pricing — is there a general price list, or does it depend on the relationship?

[11:02] Paul:
You reach out to the Notified Body that fits your device category and negotiate a price for your specific needs. There’s no general price list that I’m aware of.

[11:23] Andras:
So it’s basically a negotiation.

[11:38] Andras:
You mentioned experience with startups — any takeaways you can share?

[11:38] Paul:
There are some common misconceptions. First: people think Notified Bodies are government agencies — they’re not. They’re private organizations with governmental authorization. Second: people think they “approve” devices like the FDA does — technically, they certify them. Third: people assume any Notified Body can certify any device — that’s not true either; scope matters a lot. These misconceptions cost companies time, money, and even credibility.

[12:42] Andras:
What are some concrete misconceptions or mistakes you’ve seen?

[12:42] Paul:
We don’t plan to fail, we fail to plan. First example: a US startup chose a Notified Body without checking their scope. Turned out the Notified Body wasn’t authorized for that type of device — it set them back six months.

[13:01] Andras:
So choosing the right scope really matters.

[13:01] Paul:
Correct. Another example: a company assumed FDA clearance meant a fast CE mark. The Notified Body disagreed — particularly about clinical data — and that pushed them back a full year, costing significant time and money.

[13:35] Andras:
You mentioned it can also cost credibility — what does that mean?

[13:43] Paul:
You lose face with people in the medical device field. They might not take you as seriously, which can affect future relationships and opportunities.

[14:02] Andras:
Paul, as we wrap up — what are the key takeaways?

[14:02] Paul:
FDA clearance does not equal a CE mark — those are two different things. Europe outsources conformity assessment because it wants flexibility, specialization, and reduced political influence. Choose the right Notified Body based on scope, capacity, and communication style. The EU system isn’t chaotic — it’s just different. Understand Notified Bodies early, choose wisely, prepare thoroughly, and your CE journey will go a lot smoother. And remember: your Notified Body is not your enemy — they just need real proof that your device actually works and is safe.

[15:19] Andras:
That’s your crash course on Notified Bodies — Europe’s gatekeepers to the CE mark. If Europe is part of your go-to-market strategy, understanding this system isn’t optional, it’s essential. Paul, thank you for being here and sharing your expertise.

[15:43] Andras:
It’s an honor working with you. Stay compliant, everyone, and thank you for watching.

[15:51] Voice:
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