A Notified Body (NB) is a conformity assessment body that has been officially designated, or “notified,” by a Member State to the European Commission for the purpose of carrying out third-party conformity assessment tasks required under specific EU harmonisation legislation. Notified Bodies are listed in the NANDO (New Approach Notified and Designated Organisations) database maintained by the European Commission.
When Is a Notified Body Required?
The need for a Notified Body depends on the specific directive and the conformity assessment module chosen. The EU’s modular system defines conformity assessment routes from Module A (internal production control — self-declaration) to Module H (full quality assurance — Notified Body required at design and production level).
Notified Body is mandatory when:
| Directive / Regulation | When NB is Required |
|---|---|
| Machinery Regulation (EU 2023/1230) | Categories listed in Annex I Part A — a third-party procedure is required (module B+C, H or G); Annex I Part B — only where harmonised standards or common specifications do not cover all relevant requirements (Art. 25) |
| Medical Device Regulation (EU 2017/745) | Class IIa, IIb, and III devices — NB issues the CE certificate |
| ATEX Directive (2014/34/EU) | Categories M1 and 1, and electrical equipment and internal combustion engines in categories M2 and 2 — NB performs EU-type examination; other M2/2 equipment only lodges its technical documentation with a NB (Art. 13) |
| Pressure Equipment Directive (2014/68/EU) | Higher-risk categories of pressure equipment |
| AI Act (EU 2024/1689) | Annex III point 1 (biometric) systems where harmonised standards or common specifications are not fully applied; high-risk AI in products under Annex I Section A follows the sector act’s procedure. Annex III points 2–8 use internal control without a NB (Art. 43) |
| CRA (EU 2024/2847) | Important Class II and critical products, unless a European cybersecurity certification scheme is used; Important Class I where harmonised standards, common specifications or certification are not fully applied (Art. 32) |
Notified Body is NOT required for:
- EMC Directive (all products + harmonised standards → self-declaration)
- Low Voltage Directive (harmonised standards available → self-declaration)
- RED (most products using harmonised standards from OJEU → self-declaration)
- RoHS (always self-declaration)
- Standard/Default class CRA products (self-declaration)
What a Notified Body Does
A Notified Body’s role varies by module but typically includes:
- EU Type Examination (Module B): The NB examines the product design (Technical File, prototype testing) and issues an EU Type Examination Certificate confirming the design meets the essential requirements. This certificate is then referenced in the DoC.
- Production Quality Assurance (Module D/E): The NB audits the manufacturer’s production or product quality management system.
- Full Quality Assurance (Module H): The NB assesses and approves the complete quality management system covering design, manufacture, and final inspection.
- Product Verification (Module F): The NB tests each product or statistical samples.
A Notified Body certificate is time-limited (typically 5 years) and must be renewed. It becomes invalid if the product design changes materially or if the NB withdraws it.
Choosing a Notified Body
Not all Notified Bodies are notified for all directives. When selecting an NB:
- Check NANDO — verify the NB is currently notified for your specific directive and the relevant product category
- Check scope — even within one directive, NBs may only cover specific Annexes or product categories
- Assess capacity and turnaround — some NBs have long queues, particularly for MDR; factor this into your project timeline
- Notifying country — NANDO lists bodies notified by the EU Member States, Iceland, Liechtenstein, Norway and Türkiye, and separately bodies designated under agreements such as the MRA with Switzerland (post-Brexit, UK NBs lost their EU recognition)
Practical Impact on Project Timeline
Engaging a Notified Body adds significant time to a certification project. For example:
- MDR Class IIb device: NB engagement from contract to certificate: 12–24 months
- Machinery listed in Annex I (EU type-examination): 3–6 months for technical review
- CRA Important Class (assessment route requiring NB): 3–9 months depending on product complexity
This timeline must be planned from the start of product development — not discovered at prototype stage.
Official References
- NANDO database — Notified Bodies registry — European Commission (search for notified bodies by legislation and country)
- Regulation (EC) No 765/2008 — Notified Body accreditation framework — EUR-Lex