Self-declaration vs Notified Body: when is an NB needed?

Hugues Orgitello updated 7 Oct 2026 14 min read

Most electronic products can self-declare CE conformity: module A is the only procedure under the LVD and RoHS, an option under the EMC Directive, and always available under the RED for safety and EMC. A Notified Body becomes mandatory under the RED only for radio spectrum (Article 3(2)) and the activated Article 3(3) requirements, when cited harmonised standards are not applied in full, and under sector acts that impose one for some product classes. Decision 768/2008/EC supplies the modules, A to H with their variants; each act picks the ones it allows. This page reads the conformity assessment articles as published, as of October 7, 2026, and lists the readings the texts contradict, several of which appeared on an earlier version of this page.

TL;DR:

• Module A (internal production control) is the only procedure under the LVD and RoHS; the EMC Directive offers A or B+C; the RED offers A, B+C and H.
• Under the RED the choice is made per essential requirement. Article 3(1) (safety, EMC) and 3(4) can always use module A (Article 17(2)). Article 3(2) and 3(3) need B+C or H when cited harmonised standards are not applied, applied only in part, or do not exist (Article 17(4)).
• Since August 1, 2025, Article 3(3)(d), (e) and (f) apply to the equipment listed in Delegated Regulation (EU) 2022/30. EN 18031-1, -2 and -3 are cited with restrictions (Implementing Decision (EU) 2025/138): where a restriction applies, there is no presumption for that requirement and Article 17(4) sends it to B+C or H.
• Sector acts impose a Notified Body for some classes: ATEX categories M1, 1, M2 and 2 (with a file-lodging route for non-electrical category 2), PED from category II, every lift, Annex IV machinery without full harmonised standards coverage, MDR class IIa and above plus some class I devices.
• Under the RED, the Notified Body number follows the CE marking only with module H (Article 20(3)), not with B+C.

When is a Notified Body mandatory?

For a given product, the manufacturer first lists every act that applies, then reads each act's conformity assessment article. The module letters come from Decision 768/2008, but the menu differs per act: the same letter can be mandatory in one act, optional in another and absent from a third. The practical question is therefore twofold: does any applicable act force a third party for my product, and if not, is it worth involving one voluntarily?

Radio equipment is not assessed under the LVD or the EMC Directive

A frequent starting error is to stack "EMC + LVD + RED + RoHS" for a connected product. Article 1(4) of the RED states that radio equipment in its scope is not subject to the LVD, except as set out in Article 3(1)(a), which takes over the LVD safety objectives without its voltage limit. The EMC Directive excludes equipment covered by Directive 1999/5/EC (Article 2(2)(a)), the predecessor that the RED repealed (RED Article 50), and EMC for radio equipment is Article 3(1)(b) of the RED. A Wi-Fi or BLE product is therefore assessed under the RED and RoHS (plus any other act that applies), with a single declaration of conformity (RED Article 18(3)).

Procedures allowed, act by act

Read on October 7, 2026 against the texts listed in the sources. For the full 16 procedures of Decision 768/2008 Annex II, see the modules A to H guide.

Act	Article	Procedures allowed	Notified Body mandatory?
Directive 2014/35/EU (LVD)	Annex III	Module A only	Never
Directive 2011/65/EU (RoHS)	Article 7(b)	Module A only	Never
Directive 2014/30/EU (EMC)	Article 14	A or B+C	Never; B+C is the manufacturer's option and may be limited to some requirements
Directive 2014/53/EU (RED)	Article 17	3(1) and 3(4): A, B+C or H. 3(2) and 3(3): A, B+C or H with cited standards applied in full, otherwise B+C or H	Only for 3(2) or 3(3), when cited standards are not applied in full or do not exist
Directive 2014/34/EU (ATEX)	Article 13	M1 and 1: B+D or B+F. M2 and 2: B+C1 or B+E for engines and electrical equipment, otherwise A with the file sent to a body. Category 3: A. G always possible. No module H	Yes for categories M1, 1, M2 and 2 electrical; category 3 never
Directive 2014/68/EU (PED)	Article 14	I: A. II: A2, D1, E1. III and IV: procedures with a body (B+D, B+F, B+E, B+C2, G, H, H1 depending on the category)	From category II
Directive 2014/33/EU (Lifts)	Articles 15 and 16	Safety components: B with random checking or product QA, or full QA. Lifts: final inspection, product or production QA after a type examination or approved design, unit verification, full QA with design examination	Always
Directive 2006/42/EC (Machinery, until January 19, 2027)	Article 12	Outside Annex IV: internal checks (Annex VIII). Annex IV with harmonised standards covering all relevant requirements: Annex VIII, type examination (Annex IX) or full QA (Annex X). Otherwise: Annex IX or Annex X	Only for Annex IV machinery not fully covered by harmonised standards
Regulation 2023/1230 (Machinery, from January 20, 2027)	Article 25	Annex I Part A: B+C, H or G. Annex I Part B: A only if harmonised standards or common specifications cover all relevant requirements, otherwise B+C, H or G. Not in Annex I: A	Always for Part A; Part B unless fully covered
Regulation 2017/745 (MDR)	Article 52	Annexes IX to XI by class	Class IIa and above; class I sterile, measuring or reusable surgical devices for those aspects (Article 52(7))

For a typical connected sensor (mains or USB powered, Wi-Fi or BLE), only the RED and RoHS apply among these. RoHS imposes module A. The RED leaves module A open for the whole product if the cited Article 3(2) and 3(3) standards are applied in full.

The RED, requirement by requirement

The RED is where the choice arises most often in consumer and industrial electronics. Article 17 does not decide per product but per essential requirement:

Essential requirement	Cited harmonised standards applied in full	Not applied, applied in part, or none exist	Article
3(1)(a) health and safety	A, B+C or H	A, B+C or H	17(2)
3(1)(b) EMC	A, B+C or H	A, B+C or H	17(2)
3(4) common charger	A, B+C or H	A, B+C or H	17(2), as amended by Directive (EU) 2022/2380
3(2) effective use of the radio spectrum	A, B+C or H	B+C or H	17(3) and 17(4)
3(3)(d), (e), (f), where Delegated Regulation 2022/30 applies	A, B+C or H	B+C or H	17(3) and 17(4)

Three consequences follow from the text:

1. Safety and EMC never force a Notified Body under the RED. Whether the safety file rests on EN 62368-1 and an exposure assessment to EN 62311 or EN 50385, or on other specifications, module A remains available for Article 3(1) (Article 17(2)).
2. Partial application counts as non-application. Article 17(4) treats a cited standard "applied only in part" like a missing one for Article 3(2) and 3(3): B+C or H for that requirement. The Blue Guide (section 4.1.2.3) adds that partial application gives presumption only to the extent the parts applied cover the requirement.
3. The rest of the product can stay under module A. A manufacturer who needs a body for 3(2) still self-declares 3(1) under module A.

Typical B+C or H cases under the RED: a proprietary modulation that the cited part of EN 300 220 does not cover; a radio technology with no cited standard; equipment under Delegated Regulation 2022/30 assessed without EN 18031 or with one of its restrictions applying.

EN 18031 restrictions (Decision 2025/138)

Implementing Decision (EU) 2025/138 of January 28, 2025, published on January 30, 2025, added EN 18031-1:2024, EN 18031-2:2024 and EN 18031-3:2024 to the RED list with these restrictions:

Standard	Restriction	Requirement without presumption
EN 18031-1, -2 and -3	Clauses 6.2.5.1 and 6.2.5.2 applied so that the user is allowed "not to set and use any password"	3(3)(d), (e) or (f) respectively
EN 18031-2	Toy or childcare radio equipment (clauses 6.1.3 to 6.1.6) where parental or guardian access control is not ensured	3(3)(e)
EN 18031-3	Assessment criteria of clause 6.3.2.4 (secure updates)	3(3)(f), in every case

Each notice removes presumption only "if" its condition is met. Where the condition does not apply to the product, the standard is applied in full for that requirement and module A stays available.

The decision path

Question 1: Does any applicable act impose a Notified Body for my product?

For ATEX, the PED, lifts, Annex IV machinery or a medical device above class I, the act decides: read its conformity article in the table above. The choice then reduces to which procedure among those allowed, and which body.

If yes: the Notified Body is mandatory for that act. Go to the NANDO selection guide.

If no: continue to question 2.

Question 2: Under the RED, are the cited standards applied in full for 3(2) and 3(3)?

Check, for each Article 3(2) and activated Article 3(3) requirement, that the edition you apply is cited in the Official Journal (see RED standards), that you apply all of it, and that no restriction in the citation applies to your product.

If yes: module A is possible for the whole product. Continue to question 3.

If no: B+C or H for the requirements concerned (Article 17(4)); module A remains possible for Article 3(1) and 3(4).

Question 3: Do I want a third party anyway?

Where the act lists a third-party procedure as an option (B+C or H under the RED, B+C under EMC), the manufacturer may choose it. Reasons manufacturers give include a new technology where they want an independent view of the design, or customers who ask for a type-examination certificate. Two limits come from the texts:

• the manufacturer bears full responsibility for conformity whatever procedure is used (Blue Guide, section 3.1), and signs the declaration of conformity;
• voluntary certification does not exempt a product from market surveillance (Blue Guide, section 7.4.1).

If yes: B+C or H where the act allows them.

If no: module A.

What a Notified Body costs

No act sets fees, and NANDO publishes neither prices nor lead times. An earlier version of this page gave cost and lead-time ranges per module that we could not source; they have been removed. Ask several bodies notified for the right act, procedure and essential requirements for written quotes, and see the certification costs guide for whole-project budgeting. Laboratory tests remain the manufacturer's cost under every procedure; under module A the RED does not say who must perform them.

What the texts do fix:

• Module B (RED Annex III): design-type examination of the documentation and supporting evidence, without a specimen; the certificate states "the conditions (if any) for its validity"; any modification that may affect conformity needs an addition to the certificate (point 7).
• Module H (RED Annex IV): approval of a quality system covering design, manufacture, final inspection and testing, then "periodic audits" (point 4.3) and possible unexpected visits with tests (point 4.4). No audit frequency is set; it comes from the contract with the body. See Notified Body surveillance audits.

Choosing the right Notified Body

The NANDO database (Single Market Compliance Space) lists every body by act and Member State. Only a body notified for the act concerned can act as a Notified Body under it, and the record shows what it is notified for: specific procedures (for the RED, Annex III, Annex IV or both), specific essential requirements, specific product types.

1. Read the scope line by line. A body may be notified under the RED for Article 3(2) but not for a 3(3) point.
2. Check the language rule. Under the RED, documentation and correspondence for an EU-type examination must be in an official language of the Member State of the body or a language it accepts (Article 21(3)).
3. Get lead times and fees in writing. The texts set none.

An earlier version of this page listed named bodies with their numbers and strengths; we could not verify those entries and removed them. Read the NANDO record on the day you sign, as notifications are amended. See the NANDO selection guide.

The four-digit body number follows the CE marking only where a body is involved in production control. Under the RED that means module H only (Article 20(3)); under B+C the CE marking stands alone. See the CE procedure for the affixing rules.

Dated milestones

Date	Event	Source
June 13, 2016	RED applies; Directive 1999/5/EC repealed	RED Articles 49 and 50
January 30, 2025	EN 18031-1, -2 and -3 cited with restrictions, in force on publication	Implementing Decision (EU) 2025/138
August 1, 2025	RED Article 3(3)(d), (e) and (f) apply to the equipment listed in Delegated Regulation 2022/30	Delegated Regulation (EU) 2022/30
January 20, 2027	Machinery Regulation 2023/1230 applies, Directive 2006/42/EC repealed	Regulation 2023/1230, as corrected
December 11, 2027	Cyber Resilience Act applies in full, including its conformity assessment article	Regulation (EU) 2024/2847, Article 71

Frequent pitfalls

On the self-declaration side

• Presumption claimed without checking the citation. A declaration that cites a harmonised standard gives presumption only for the edition cited in the Official Journal, applied in full, and subject to any restriction in the citation. See RED standards.
• Standards withdrawn from the list. After the withdrawal date the edition no longer gives presumption; for RED 3(2) or 3(3), keeping it means Article 17(4) applies.
• Certified radio modules. Integrating a module that has its own declaration does not make the end product compliant by itself: the manufacturer of the end product carries out the conformity assessment of the end product and keeps its own technical documentation (RED Articles 10(2), 17(1) and 21).
• No risk analysis. The reference module A requires the technical documentation to include "an adequate analysis and assessment of the risk(s)" (Decision 768/2008, Annex II, module A, point 2), and RED Annex III point 3(c) requires it in every type-examination file.
• Incorrect declaration of conformity. A declaration not drawn up, or not drawn up correctly, is a formal non-compliance that the authority requires the operator to end (RED Article 43(1)(d) and (e)).

On the Notified Body side

• Requirements not specified in the application. Under the RED, the technical documentation lodged with the body "shall specify the applicable requirements" (Annex III point 3(c)); define which ones the body assesses before signing.
• Treating the certificate as a marketing authorisation. The type-examination certificate attests one step; the manufacturer draws up the declaration and remains responsible (Blue Guide, section 3.1).
• Changing the approved type without telling the body. RED Annex III point 7 requires an addition to the certificate for modifications that may affect conformity.
• Forgetting quality system surveillance under modules D, E and H: the body carries out periodic audits and may pay unexpected visits; the frequency comes from the contract, not from the Decision.

The US analogue: SDoC vs certification

The FCC has its own split:

• SDoC (Supplier's Declaration of Conformity): available for most unintentional radiators under Part 15 Subpart B, where the table in 47 CFR 15.101(a) lists "SDoC or Certification"; some devices, such as scanning receivers and radar detectors, require certification.
• Certification by a TCB (Telecommunication Certification Body): required for intentional radiators operating under Part 15 (47 CFR 15.201(b)), with exceptions listed in 15.201(a).

See the FCC procedure. The analogy is loose: FCC certification produces an FCC ID for the device, while the EU issues no central identifier and a Notified Body certificate covers only the requirements and procedure it was asked to assess.

Worked examples

Case A: Wi-Fi or BLE sensor, USB powered, connected to the internet

Applicable acts: RED and RoHS. Article 3(1)(a) rests on EN 62368-1 and EN 62311; Article 3(1)(b) on EN 301 489-17 with its common part; Article 3(2) on EN 300 328; Article 3(3)(d) on EN 18031-1, applied without the option letting the user skip passwords. EMC test methods such as EN 55032 and EN 55035 may also appear in the file as other specifications for 3(1)(b).

Decision: module A for the whole product, provided the 3(2) and 3(3) standards are cited editions applied in full. No Notified Body, no number next to the CE marking.

Case B: 868 MHz transmitter with a proprietary modulation

The modulation is not covered by the cited part of EN 300 220. Safety and EMC are documented.

Decision: B+C or H for Article 3(2) (Article 17(4)); module A remains possible for 3(1). Under B+C, the CE marking carries no body number.

Case C: 4G/5G router whose security design falls outside EN 18031

Delegated Regulation 2022/30 applies, and the security design is not covered by EN 18031, so there is no presumption for Article 3(3)(d), (e) or (f).

Decision: B+C or H for the 3(3) points concerned. Operator or industry programmes such as PTCRB are not part of the RED procedure and are not run by Notified Bodies; see the PTCRB pillar.

Claims the texts contradict

Claim	What the text says
"RED module A needs EN 62368-1 and EN 62311 or EN 50385; otherwise Article 3(1)(a) needs a third-party examination"	Article 17(2): A, B+C or H are available for Article 3(1) whatever specifications are used
"Only a standard that is not applied at all triggers a Notified Body"	Article 17(4): standards "not applied or applied only in part", or no standard, send 3(2) and 3(3) to B+C or H
"EN 18031 partially applied: module B+C"	B+C or H (Article 17(4)); module H is also open
"A connected product needs EMC + LVD + RED + RoHS"	RED Article 1(4) excludes RED equipment from the LVD except through 3(1)(a); the EMC Directive excludes equipment covered by Directive 1999/5/EC, now the RED (EMC Article 2(2)(a), RED Article 50)
"Under B+C the Notified Body number accompanies the CE marking"	RED Article 20(3): only where Annex IV (module H) is applied
"Modules D, E and H mean annual audits"	Decision 768/2008 and RED Annex IV point 4.3 say "periodic audits", with no frequency; some sector acts set one, for example at least every 12 months under MDR Annex IX
"ATEX: B+C, B+D, B+E, B+F, G or H"	Article 13: B+D, B+F, B+C1, B+E, A (with or without the file sent to a body) and G; there is no module H, and category 3 uses module A
"Machinery: B+C or H for Annex IV"	Directive 2006/42/EC uses its own Annexes VIII to X; Annex IV machinery fully covered by harmonised standards may use internal checks (Article 12(3)). B+C, H and G appear with Regulation 2023/1230 from January 20, 2027
"MDR: a Notified Body from class IIa"	Also class I sterile, measuring and reusable surgical devices for those aspects (Article 52(7))
"A type-examination certificate opens third-country markets"	No EU act says so; recognition by a third country depends on that country, and EU mutual recognition agreements are sector by sector
"Module B+C costs EUR 8,000 to 30,000 and adds 6 to 16 weeks; module H costs EUR 30,000 to 80,000 upfront"	No primary source sets fees or lead times; the figures were removed

See also

• Conformity assessment modules A to H (768/2008/EC)
• RED conformity assessment: modules A, B+C and H
• The CE procedure
• Choosing a Notified Body in NANDO
• Notified Body surveillance audits
• RED checklist
• Machinery Directive 2006/42 and Regulation 2023/1230
• ATEX: equipment for explosive atmospheres
• RED pillar

Working on choosing the assessment module for a specific product for a real product? AESTECHNO can audit your design and certification plan. Get in touch

Sources & references

1. Decision No 768/2008/EC, Annex I (R11, R12) and Annex II (modules), EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
2. Directive 2014/53/EU (RED), Articles 1(4), 17, 20, 21, 43 and Annexes II to IV, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
3. Directive 2014/53/EU, consolidated text of 28 December 2024 (Article 17(2) as amended by Directive (EU) 2022/2380), EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02014L0053-20241228
4. Delegated Regulation (EU) 2022/30, RED Article 3(3)(d), (e) and (f), EUR-Lex eur-lex.europa.eu/eli/reg_del/2022/30/oj
5. Implementing Decision (EU) 2025/138, EN 18031-1, -2 and -3 cited with restrictions, EUR-Lex eur-lex.europa.eu/eli/dec_impl/2025/138/oj
6. Directive 2014/30/EU (EMC), Articles 2 and 14, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
7. Directive 2014/35/EU (LVD), Annex III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
8. Directive 2011/65/EU (RoHS), Article 7, EUR-Lex eur-lex.europa.eu/eli/dir/2011/65/oj
9. Directive 2014/34/EU (ATEX), Article 13, EUR-Lex eur-lex.europa.eu/eli/dir/2014/34/oj
10. Directive 2014/68/EU (PED), Article 14, EUR-Lex eur-lex.europa.eu/eli/dir/2014/68/oj
11. Directive 2014/33/EU (Lifts), Articles 15 and 16, EUR-Lex eur-lex.europa.eu/eli/dir/2014/33/oj
12. Directive 2006/42/EC (Machinery), Article 12, EUR-Lex eur-lex.europa.eu/eli/dir/2006/42/oj
13. Regulation (EU) 2023/1230 (Machinery), Article 25, EUR-Lex eur-lex.europa.eu/eli/reg/2023/1230/oj
14. Regulation (EU) 2017/745 (MDR), Article 52, EUR-Lex eur-lex.europa.eu/eli/reg/2017/745/oj
15. Blue Guide 2022 on the implementation of EU product rules (sections 3.1, 4.1.2.3, 5.1 and 7.4.1), Publications Office of the European Union eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
16. NANDO, Notified bodies database (Single Market Compliance Space), European Commission webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
17. 47 CFR 15.101, equipment authorization of unintentional radiators, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-B/section-15.101
18. 47 CFR 15.201, equipment authorization requirement for intentional radiators, eCFR www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-15/subpart-C/section-15.201