How to Find and Choose the Right Notified Body for CE Certification

If your product requires Notified Body assessment (medical devices, PPE, ATEX, fire alarms, and other high-risk products), choosing the right Notified Body is one of the most important decisions you’ll make. A bad choice adds months to your timeline and tens of thousands to your budget. A good choice means smooth certification and ongoing compliance support. I’ve worked with 15+ Notified Bodies across Europe, and here’s what I’ve learned. For a complete overview of the CE certification process, see my CE certification guide.

What Is a Notified Body and When Do You Need One?

A Notified Body is an organization designated by an EU member state to assess product conformity against EU directives. They’re listed in the NANDO (New Approach Notified and Designated Organisations) database. You need one when your product’s conformity assessment module requires third-party involvement — for example, medical devices (MDR), PPE Category III, or ATEX equipment Category 1 or 2. Low-risk products can be self-declared without a Notified Body.

How to Search the NANDO Database

Go to the European Commission’s NANDO website. Filter by directive (e.g., MDR, PPE, ATEX, PED). Check the Notified Body’s scope — each NB is designated for specific directives and specific conformity assessment modules. Review their notification number (e.g., NB 0123), which appears next to the CE mark on certified products. Check the notification status — some NBs have limited, suspended, or withdrawn notifications. I always verify this before engaging.

Criteria for Choosing the Right Notified Body

Technical expertise: do they understand your product category? Capacity: what’s their current workload and wait time? Location: proximity helps for on-site audits. Language: are their auditors fluent in English? Cost: compare quotes from 3-5 NBs. Response time: how fast do they answer technical questions? Reputation: ask other manufacturers about their experience. I’ve seen companies choose a cheaper NB with longer wait times and lose more in delayed market entry than they saved in certification fees.

What Questions to Ask Before Signing a Contract

How many products like mine have you certified? What’s your current lead time for initial assessment? Do you offer pre-assessment services? What happens if a standard changes during our certification process? What’s your policy for design changes after certification? How do you handle complaints and appeals? How long are your certificates valid? The answers reveal a lot about whether the NB is a partner or just a certification factory.

Common Notified Body Pitfalls

Choosing an NB without the right scope for your directive (your certification is invalid). Waiting 6-12 months for an overbooked NB. Getting inconsistent interpretations from different auditors (common in new directives like MDR). Paying for unnecessary re-testing because the NB doesn’t recognize existing test data. These are expensive mistakes. Take your time choosing — it’s the most important certification decision you’ll make.

For budgeting purposes, check my CE certification cost breakdown with product-specific estimates.

I discuss common compliance failures in the CE marking mistakes guide.

References

1. NANDO Database — EU’s official searchable registry of all designated Notified Bodies.
2. European Commission: Notified Bodies — Guidance on NB designation and selection criteria.