When you need a Notified Body — the EU CE marking decision guide
Decision guide for when a Notified Body must be involved in EU conformity assessment — by directive, by product type, by module — plus how to find one and what it costs.
By Vladimír Vician
A Notified Body (NB) is a third-party conformity assessment body designated by an EU member state and notified to the European Commission under specific directives. When the directive applicable to your product requires Modules B through H — see Conformity assessment Modules A through H — an NB must be involved.
This article is the decision guide: when an NB is mandatory, when self-assessment under Module A is sufficient, how to find the right NB, what they cost, and what they actually do.
The default is self-assessment
For the majority of CE-marked products in 2026, no Notified Body is involved. The manufacturer performs the conformity assessment internally under Module A, signs the Declaration of Conformity, and affixes the CE mark on its own authority. This is the default for:
- Most consumer electronics under LVD + EMC
- Most RoHS-only products
- Most non-radio Internet of Things consumer products under CRA (standard products, not in Annex III or IV)
- Most products where harmonised standards are fully applied
The presumption: where harmonised standards listed in the Official Journal are correctly applied, the manufacturer's internal evidence is enough to substantiate the Declaration of Conformity.
When a Notified Body becomes mandatory
NB involvement is required when the directive's conformity assessment article forbids Module A for the product's risk class, or when the manufacturer chooses (or is forced) not to fully apply harmonised standards.
By directive — when NB is typically required
| Directive | NB required for |
|---|---|
| Radio Equipment Directive 2014/53/EU | Annex IV path — when harmonised standards under Article 16(2) are not fully applied. Article 17(2)(c). |
| Medical Device Regulation 2017/745 | Class IIa, IIb, and III. Annex VII categorisation. Class I sterile or measuring also requires NB. |
| In Vitro Diagnostic Regulation 2017/746 | Class B, C, and D devices. Self-test and near-patient testing devices in Class A. |
| Pressure Equipment Directive 2014/68/EU | Categories I (sometimes), II, III, and IV — module choice depends on hazard category from Annex II. |
| Lifts Directive 2014/33/EU | All lifts and safety components — Modules B+C, B+D, B+E, B+F, G, H, or H1. No Module A. |
| Personal Protective Equipment Regulation 2016/425 | Category II (B+C2/D/E) and Category III (B + D or E). |
| Toys Directive 2009/48/EC | Module B+C — when harmonised standards are not fully applied or when the product contains substances of concern. |
| ATEX 2014/34/EU | Categories 1 (highest hazard, B+F or B+D); Category 2 (B+D, B+E, B+F); Category 3 (Module A only). |
| Machinery Directive / Regulation 2023/1230 | Annex IV listed machinery (saws, presses, lifts, etc.) — Module B+C or H. |
| Cyber Resilience Act (EU) 2024/2847 | Important Class I and II in Annex III; always for critical products in Annex IV (plus EU certification scheme). Standard products: Module A. |
| Marine Equipment Directive 2014/90/EU | All in-scope marine equipment — module choice depends on equipment category. |
By red flag — features that typically push you into NB territory
Independent of which directive applies, certain product features almost always trigger NB involvement:
- Radio transmitter on a product not fully applying RED harmonised standards — RED Annex IV
- Medical claim about diagnosis or treatment — MDR
- Pressure containment above 0.5 bar gauge in non-trivial categories — PED
- Moving parts above thresholds in the Machinery Annex IV list — Machinery Directive Annex IV listed machinery
- Explosion atmosphere intended use above Category 3 — ATEX
- CRA Annex III important product types — identity / password / network management / firewalls / VPN / OS / certificate authority / etc.
- Lifts — Lifts Directive
- Personal protective equipment for irreversible damage — PPE Category III
NANDO — finding the right Notified Body
The NANDO (New Approach Notified and Designated Organisations) database is maintained by the European Commission at single-market-economy.ec.europa.eu/single-market/goods/building-blocks/notified-bodies_en.
NANDO lets you:
- Search by directive — list every Notified Body designated for, say, RED
- Search by NB number — look up what designation a specific NB holds (e.g. 0123 = TÜV SÜD, 0359 = BSI Group)
- Search by member state — filter NBs based in a specific country
- Verify scope — each NB has a defined scope within each directive (one NB might be designated for radio equipment but not for medical devices)
Critical: the NB you engage must be designated for the specific directive you need assessment under. An NB designated for the EMC Directive cannot issue conformity assessment under RED unless it is also designated for RED.
Choosing among eligible NBs
Practical selection criteria:
- Sector expertise — does the NB regularly assess products like yours? An NB that does mostly automotive ECUs may technically be designated for CRA but lack practical experience with IoT firmware
- Geography and language — local NB often means faster turnaround and easier site audits
- Cost transparency — ask for a written quote including assessment + certificate + surveillance fees
- Lead time — top-tier NBs (TÜV SÜD, DEKRA, SGS, BSI, TÜV Rheinland, Intertek) often have 3–6 month queues; smaller specialist NBs can be faster
- Existing relationships — if you already work with one NB on another product, they typically prioritise repeat clients
The largest pan-European NBs cover most directives:
- TÜV SÜD (DE)
- TÜV Rheinland (DE)
- DEKRA (DE)
- SGS (CH/global)
- BSI Group (UK/EU)
- Intertek (UK/global)
- Bureau Veritas (FR)
- UL Solutions (US/EU)
- Eurofins (FR)
Smaller national NBs often specialise — for example CCQS in Ireland for medical devices, Element (was TRaC) in the UK / EU branches for radio and EMC, VDE in Germany for electrical safety.
What a Notified Body actually does
For Module B (EU-type examination):
- Manufacturer submits Technical File + representative sample(s) of the product
- NB performs document review of the design, risk assessment, test reports, software architecture
- NB performs (or witnesses) product testing — EMC chamber, radio tests, safety tests, cybersecurity tests
- NB documents any non-conformities and requests remediation
- Once conformant, NB issues an EU-type examination certificate valid typically 5 years
- Manufacturer references the certificate number on the Declaration of Conformity
For Module D / H (QMS assessment):
- Manufacturer submits QMS documentation (procedures, work instructions, records)
- NB performs Stage 1 audit — desk review of documentation
- NB performs Stage 2 audit — on-site audit of the QMS operation
- NB issues QMS approval typically valid 3 years
- NB performs annual surveillance audits to verify ongoing QMS operation
- NB performs re-certification audit at the end of the certificate validity
For Module F (per-unit verification) and Module G (unit verification):
- NB inspects (and tests) each manufactured unit before the unit is placed on the market
- NB issues a per-unit certificate
- Module G has no preceding Module B — each unit is assessed end-to-end
Cost ranges in 2026
Order-of-magnitude figures, varying by NB, sector, and product complexity:
| Module / Scope | Typical cost range |
|---|---|
| Module B for low-complexity electronics under RED | €8 000 – €18 000 |
| Module B for mid-complexity industrial product under MDR Class IIa | €20 000 – €45 000 |
| Module H full QMS (initial) for medical Class IIb | €25 000 – €60 000 |
| Module H annual surveillance | €4 000 – €10 000 |
| Module F per-unit verification (e.g. PED Category III) | €2 000 – €8 000 per unit |
| MDR Class III certification (full scope) | €60 000 – €150 000+ |
| CRA Annex IV critical product certification | varies — EU certification scheme not fully priced as of mid-2026 |
| Annual NB renewals and re-certification | typically 30–50% of initial cost every 3–5 years |
Lab testing (EMC chambers, radio test labs, mechanical safety labs) is usually billed separately from NB fees and adds €3 000 to €15 000 per testing campaign depending on directive(s).
NB number on product and Declaration of Conformity
When a Notified Body has been involved, its four-digit identification number must appear beside the CE mark on the product itself (or on its packaging and accompanying documents if the product surface does not permit). The number identifies the NB to market surveillance authorities and verifies the assessment chain.
Example: a CE-marked Wi-Fi product assessed under RED Annex IV with TÜV SÜD as the Notified Body would show CE 0123 on the product. The Declaration of Conformity references the NB by name, address, identification number, and certificate reference.
Missing the NB number when one was involved is grounds for product withdrawal under Article 30 of Regulation 765/2008.
How Cenitia helps the decision
Cenitia's auto-mapper identifies for each applicable directive whether your product can use Module A self-assessment or whether NB involvement is required, based on:
- The directive's conformity assessment article
- The product's risk class within the directive
- Whether the cited harmonised standards are fully applied
- The product's intended markets
The output is documented in the Technical File draft. When NB involvement is recommended, our parent company Inovasense can advise on NB selection and audit preparation under a separate consulting engagement.
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Frequently asked questions
What is a Notified Body?
A Notified Body (NB) is a conformity assessment body officially designated by an EU member state and notified to the European Commission to perform third-party assessment tasks under specific directives. NBs are listed in the NANDO database with the directive(s) they are designated for, a four-digit identification number, and contact details. They are not government agencies — most are private organisations such as TÜV, DEKRA, SGS, BSI, Intertek, UL Solutions, and national standards bodies.
When is a Notified Body mandatory?
Whenever the directive applicable to the product requires Modules B, C1, C2, D, E, F, G, or H. The most common triggers in 2026: medical devices Class IIa and above under MDR; most radio equipment under RED Annex IV (when harmonised standards are not fully applied); pressure equipment above PED Category II; lifts; personal protective equipment Category III; toys when harmonised standards are not fully applied; ATEX equipment above Category 3; important products Class I and II in CRA Annex III; critical products in CRA Annex IV.
How do I find a Notified Body?
The NANDO (New Approach Notified and Designated Organisations) database hosted by the European Commission lists every Notified Body, their designation, and the directives they are designated for. Filter by directive to find the NBs eligible to perform assessment for your product. Each NB has a four-digit identification number (e.g. 0123, 0359) that appears beside the CE mark on the product and on the Declaration of Conformity.
Can I choose any Notified Body in the EU?
Yes. Notified Bodies are designated by member states but operate across the entire EU single market. A German NB can certify a product made by a Slovak manufacturer for sale in France. The choice is typically driven by cost, lead time, language, sector expertise, and existing relationships. Larger NBs (TÜV SÜD, DEKRA, SGS) cover most directives; smaller specialist NBs focus on narrow domains.
How much does a Notified Body assessment cost?
Typical 2026 ranges: Module B (EU-type examination) for a low-to-mid complexity product €8 000 to €25 000; Module H (full QMS assessment + surveillance) €15 000 to €40 000 initial certification plus annual surveillance €4 000 to €10 000; medical Class IIa Notified Body certification €20 000 to €50 000; medical Class III much higher. Specialised assessments (CRA critical products under Annex IV, pressure equipment Category IV) can exceed €100 000. The NB certificate is typically valid for five years subject to surveillance audits.
How long does a Notified Body assessment take?
For a Module B EU-type examination on a low-to-mid complexity product, typically 3–6 months from full Technical File submission to certificate issuance — bounded by NB capacity and queue, lab testing turnaround, and any back-and-forth on documentation gaps. Module H QMS approval typically 6–9 months including an on-site audit. Medical devices and critical CRA products can take 12 months or longer. Plan NB engagement at least 6 months ahead of intended product launch.
Related from the Library
- CE Marking 101 — the complete EU guide — umbrella pillar
- Conformity assessment Modules A through H — the procedures the NB executes
- CRA Annex I explained — the cybersecurity essentials a CRA-relevant NB assessment checks against
- Declaration of Conformity 101 — where the NB number ends up cited
Further reading
- NANDO — Notified Body database
- Decision 768/2008/EC — Annex II conformity assessment modules
- Regulation 765/2008 — accreditation and market surveillance, Article 30 on CE marking
- Blue Guide — implementation of EU product rules
- Cyber Resilience Act Annexes III and IV — important and critical products
Last reviewed: 15 June 2026. Cited regulations watched continuously by Cenitia — when one amends, this article is flagged for update.
FAQ
Frequently asked questions
What is a Notified Body?
A Notified Body (NB) is a conformity assessment body officially designated by an EU member state and notified to the European Commission to perform third-party assessment tasks under specific directives. NBs are listed in the NANDO database with the directive(s) they are designated for, a four-digit identification number, and contact details. They are not government agencies — most are private organisations such as TÜV, DEKRA, SGS, BSI, Intertek, UL Solutions, and national standards bodies.
When is a Notified Body mandatory?
Whenever the directive applicable to the product requires Modules B, C1, C2, D, E, F, G, or H. The most common triggers in 2026: medical devices Class IIa and above under MDR; most radio equipment under RED Annex IV (when harmonised standards are not fully applied); pressure equipment above PED Category II; lifts; personal protective equipment Category III; toys when harmonised standards are not fully applied; ATEX equipment above Category 3; important products Class I and II in CRA Annex III; critical products in CRA Annex IV.
How do I find a Notified Body?
The NANDO (New Approach Notified and Designated Organisations) database hosted by the European Commission lists every Notified Body, their designation, and the directives they are designated for. Filter by directive to find the NBs eligible to perform assessment for your product. Each NB has a four-digit identification number (e.g. 0123, 0359) that appears beside the CE mark on the product and on the Declaration of Conformity.
Can I choose any Notified Body in the EU?
Yes. Notified Bodies are designated by member states but operate across the entire EU single market. A German NB can certify a product made by a Slovak manufacturer for sale in France. The choice is typically driven by cost, lead time, language, sector expertise, and existing relationships. Larger NBs (TÜV SÜD, DEKRA, SGS) cover most directives; smaller specialist NBs focus on narrow domains.
How much does a Notified Body assessment cost?
Typical 2026 ranges: Module B (EU-type examination) for a low-to-mid complexity product €8 000 to €25 000; Module H (full QMS assessment + surveillance) €15 000 to €40 000 initial certification plus annual surveillance €4 000 to €10 000; medical Class IIa Notified Body certification €20 000 to €50 000; medical Class III much higher. Specialised assessments (CRA critical products under Annex IV, pressure equipment Category IV) can exceed €100 000. The NB certificate is typically valid for five years subject to surveillance audits.
How long does a Notified Body assessment take?
For a Module B EU-type examination on a low-to-mid complexity product, typically 3–6 months from full Technical File submission to certificate issuance — bounded by NB capacity and queue, lab testing turnaround, and any back-and-forth on documentation gaps. Module H QMS approval typically 6–9 months including an on-site audit. Medical devices and critical CRA products can take 12 months or longer. Plan NB engagement at least 6 months ahead of intended product launch.
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Put this into practice
Free tools & references
- Do I need a Notified Body?Find out, per regulation, whether a Notified Body is required.Open tool →
- EU Directive SelectorDescribe your product and find which EU directives and regulations apply.Open tool →
New to the terminology? Browse the compliance glossary — plain-English, citation-backed definitions of every term above.