How to Select a Notified Body for CE Marking (2026)

What Is a Notified Body?

A Notified Body (NB) is an organisation designated by an EU member state to carry out third-party conformity assessment under specific EU legislation. Notified Bodies are independent, accredited organisations — not government agencies — that assess whether products meet EU safety and performance requirements before or during CE marking.

Not every CE marking route requires a Notified Body. But for higher-risk products — including Class IIa, IIb, and III medical devices, certain PPE categories, pressure equipment above specific thresholds, and machinery covered by Annex I of the Machinery Regulation — a Notified Body's involvement is legally mandatory.

Only bodies officially designated and listed in the NANDO database (New Approach Notified and Designated Organisations) can legally issue EU certificates. A certificate from a non-notified body has no legal validity for CE marking purposes.

When Do You Need a Notified Body?

You need a Notified Body when the applicable EU directive or regulation requires third-party conformity assessment for your product's risk class or category:

• MDR 2017/745: Class IIa, IIb, III medical devices (and Class I devices with a measuring function, sterile devices, or reusable surgical instruments)
• IVDR 2017/746: Class B, C, and D in vitro diagnostic devices
• PPE Regulation 2016/425: Category II and Category III PPE
• Machinery Regulation 2023/1230: Products listed in Annex I (high-risk machinery)
• PED 2014/68/EU: Pressure equipment in Categories II, III, and IV
• ATEX Directive 2014/34/EU: Equipment Groups I and II, Categories 1 and 2
• CPR 305/2011: Construction products where AVCP system 1 or 1+ applies

How to Find a Notified Body: The NANDO Database

The official starting point is the NANDO database (ec.europa.eu/growth/tools-databases/nando). You can search by:

• Directive or regulation
• Annex or module
• Product category or CN code
• Country of establishment

For medical devices, the EUDAMED database also lists designated NBs and their certification scope. Cross-referencing both is recommended for MDR/IVDR applications.

NANDO search returns Notified Bodies by their designation scope — which is critical. A body designated for Class IIa general medical devices is not necessarily designated for Class III implantables, even if they are the same organisation. Always verify the specific scope matches your product.

Key Criteria for Selecting the Right Notified Body

The MDR Notified Body Capacity Problem

Since MDR 2017/745 came into full effect, the medical device industry has faced a significant Notified Body capacity crisis. Under the previous MDD, there were over 50 NBs designated for medical devices. Under MDR, fewer than 25 bodies are currently designated, with some having extremely limited capacity for complex devices.

The practical implications for manufacturers:

• Application queues of 12–24 months for Class IIb and III devices at many NBs
• Pre-submission meetings required before applications are even accepted
• Significant documentation quality requirements before an NB will commence formal review
• Premium pricing compared to the MDD era

Pre-Submission Meetings: Use Them

Most Notified Bodies offer (and often require) a pre-submission meeting before accepting a formal application. This meeting serves several purposes:

• Allows the NB to assess whether your product falls within their designation scope
• Gives you an opportunity to present your regulatory strategy and get NB feedback
• Lets you evaluate the NB's expertise and communication style
• Helps identify documentation gaps before the formal application clock starts
• Establishes a relationship with the NB reviewer team

Prepare for the pre-submission meeting with a clear product description, intended purpose, risk classification justification, and a summary of your conformity assessment approach. A regulatory consultant can help structure this presentation effectively.

Questions to Ask Before Choosing a Notified Body

• Are you currently designated under [specific directive/regulation] for [product code/category]?
• What is your current application backlog for [device class/product type]?
• How long from application acceptance to certificate issuance for a typical [class] device?
• What documentation do you require at application stage vs. during review?
• Do you conduct audits at our manufacturing site, or can this be done remotely?
• What are your annual surveillance requirements after initial certification?
• How do you handle significant design changes or substantial modifications post-certification?
• What is the process for transferring a certificate from another NB?

The Application Process: What to Expect

1. Pre-submission enquiry — contact the NB to confirm scope and current capacity
2. Pre-submission meeting — present regulatory strategy, receive NB feedback
3. Formal application — submit application form, product documentation summary, and fees
4. Application review — NB assesses completeness; may request additional information
5. Technical documentation review — detailed review of technical file, risk management, clinical data
6. On-site audit — QMS audit at manufacturing site(s) (for applicable modules)
7. Non-conformities — if identified, you must respond with corrective actions
8. Certificate issuance — NB issues the EU certificate of conformity
9. Annual surveillance — ongoing audits and document reviews to maintain the certificate

Switching Notified Bodies

It is possible to transfer your certification from one Notified Body to another. Reasons include: NB losing its designation, better service or pricing elsewhere, or NB no longer covering your expanded product range.

The transfer process involves the new NB reviewing existing documentation and potentially conducting a partial or full reassessment. The outgoing NB must be notified. Plan for 3–6 months for a smooth transfer. Your product can remain on the market during the transfer if certificates remain valid.

Frequently Asked Questions