What is Decision 768/2008/EC and why is it called horizontal?

Decision No 768/2008/EC of 9 July 2008 sets a common framework for the marketing of products. Its Annex II lays down the conformity assessment modules A to H and their variants. It binds no manufacturer directly: Article 4 says that where Union harmonisation legislation requires conformity assessment, the procedures are chosen from the Annex II modules. Each sector act (RED, EMC, ATEX, PED, Machinery, MDR, CRA) then lists which procedures apply to its products. The Decision repealed Decision 93/465/EEC.

How many modules and procedures are there?

Eight modules, named A to H, of which six have variants: A1, A2, C1, C2, D1, E1, F1 and H1. The Blue Guide 2022 (section 5.1.8) counts 16 possible procedures, because module B is never used alone: it is always followed by C, C1, C2, D, E or F.

What is the difference between module B and module C?

Module B (EC-type examination, EU-type examination in the sector acts) covers design: a notified body examines the technical design and, depending on the variant, a specimen, and issues a type-examination certificate. Module C covers production: the manufacturer ensures, under its own internal production control, that each unit conforms to the approved type, with no further notified body involvement. B is always paired with a production module.

What is the difference between modules D, E and H?

All three rest on a quality system approved and audited by a notified body. Under module D the quality system covers production, final product inspection and testing. Under module E it covers only final product inspection and testing. Under module H it covers design, manufacture and final product inspection and testing, with no type examination. D and E follow module B; H does not.

Do A1 and A2 mean tests at random and at fixed intervals?

No. In Annex II, A1 (and C1) means supervised product testing: tests on specific aspects of each product, carried out by an accredited in-house body or under the responsibility of a notified body. A2 (and C2) means supervised product checks at random intervals determined by the body, on a sample taken before placing on the market. No module in Annex II sets fixed intervals.

How long is an EU-type examination certificate valid?

Decision 768/2008 sets no period: the certificate states the conditions, if any, for its validity. Some sector acts fix one: 10 years renewable under the PED and the NAWI Directive, at most five years under the Machinery Regulation 2023/1230 and the MDR. The RED, the EMC Directive, the CRA and ATEX set none (ATEX Guidelines, paragraph 186).

Does the RED allow module A for every product?

For the Article 3(1) requirements (safety and EMC), yes: Article 17(2) allows module A, B+C or H whatever the standards used. For Article 3(2) and 3(3), module A is only available when harmonised standards cited in the Official Journal have been applied in full. If they were not applied, applied in part, or do not exist, Article 17(4) requires B+C or H for those requirements.

Which documents does each module produce?

In every module the manufacturer draws up the declaration of conformity and keeps it, with the technical documentation, for 10 years after placing on the market unless the sector act alters the period. Module B produces a type-examination certificate, H1 an EC design examination certificate, D, D1, E, E1, H and H1 a quality system approval with audit reports, and F, F1 and G a certificate of conformity from the notified body.

Conformity assessment modules A to H (768/2008/EC)

Hugues Orgitello updated 7 Oct 2026 18 min read

Decision 768/2008/EC is the horizontal text whose Annex II lays down the conformity assessment modules reused by the CE marking directives and regulations: eight modules, A to H, and eight variants. No manufacturer applies the Decision directly. Each sector act (Low Voltage, EMC, RED, ATEX, PED, Machinery, MDR, CRA) picks from this menu the procedures allowed for its products and writes them into its own conformity assessment article. This page sets out what Annex II actually says about each module, an article-by-article table of what each act allows, and the readings the texts contradict, several of which appeared on an earlier version of this page.

Origin: from Decision 93/465/EEC to the New Legislative Framework

The modules were first laid down in Council Decision 93/465/EEC of 22 July 1993, which also set the rules for affixing the CE marking (Decision 768/2008, recital 13 and Article 8). In July 2008 the legislator adopted the New Legislative Framework (NLF):

Regulation (EC) No 765/2008 of 9 July 2008, on accreditation and, originally, market surveillance. Since 16 July 2021 its market surveillance chapter (Articles 15 to 29) is deleted and replaced by Regulation (EU) 2019/1020 (Article 39 of that Regulation).
Decision No 768/2008/EC of 9 July 2008 (OJ L 218, 13 August 2008), which repealed Decision 93/465/EEC. Its Annex I holds the reference provisions (Articles R1 to R34: definitions, obligations of economic operators, CE marking principles in R11 and R12, notified bodies, safeguard procedures), Annex II the modules, Annex III the model declaration of conformity.
Regulation (EC) No 764/2008 on mutual recognition, since repealed by Regulation (EU) 2019/515.

Article 4 of the Decision tells the legislator how to choose: the module must suit the type of product, match the nature and degree of risk, give the manufacturer a choice between quality assurance and product certification modules where a third party is mandatory, and avoid modules too burdensome for the risk (Article 4(1)). For custom-made products and small series, the conditions are to be alleviated (Article 4(4)). A sector act may also require more technical documentation or change the 10-year retention period (Article 4(5)).

The Decision speaks of "EC-type examination" and "EC declaration of conformity". The acts aligned on it since 2014 (EMC 2014/30/EU, LVD 2014/35/EU, RED 2014/53/EU, ATEX 2014/34/EU, Lifts 2014/33/EU, PED 2014/68/EU, NAWI 2014/31/EU and others) use "EU-type examination" and "EU declaration of conformity". The Blue Guide 2022, chapter 5, explains how the modules are built and chosen.

The 16 procedures of Annex II

The Blue Guide (section 5.1.4) counts eight modules, A to H, several with variants. Because module B covers design only, it is always followed by a production module, which gives 16 procedures (section 5.1.8): A, A1, A2, B+C, B+C1, B+C2, B+D, D1, B+E, E1, B+F, F1, G, H, H1.

Module	Title in Annex II	Phase covered (Blue Guide 5.1.7)	Third-party role	NB number on the product
A	Internal production control	Design and production	None	No
A1	Internal production control plus supervised product testing	Design and production	Tests on specific aspects of each product, by an accredited in-house body or under the responsibility of a notified body (NB)	Yes, when an NB carries out the tests
A2	Internal production control plus supervised product checks at random intervals	Design and production	Product checks at random intervals set by the body, on a sample taken before placing on the market	Yes, when an NB carries out the tests
B	EC-type examination	Design	NB examines the technical design, with or without a specimen, and issues a type-examination certificate	Not under B itself
C	Conformity to type based on internal production control	Production, after B	None	No
C1	C plus supervised product testing	Production, after B	As A1	Yes, when an NB carries out the tests
C2	C plus supervised product checks at random intervals	Production, after B	As A2	Yes, when an NB carries out the tests
D	Conformity to type based on quality assurance of the production process	Production, after B	NB approves and audits the quality system for production, final product inspection and testing	Yes
D1	Quality assurance of the production process	Design and production	As D, without type examination	Yes
E	Conformity to type based on product quality assurance	Production, after B	NB approves and audits the quality system for final product inspection and testing	Yes
E1	Quality assurance of final product inspection and testing	Design and production	As E, without type examination	Yes
F	Conformity to type based on product verification	Production, after B	NB examines and tests every product, or a statistical sample of each lot	Yes
F1	Conformity based on product verification	Design and production	As F, without type examination	Yes
G	Conformity based on unit verification	Design and production	NB examines and tests each individual product	Yes
H	Conformity based on full quality assurance	Design and production	NB approves and audits the quality system for design, manufacture, final inspection and testing	Yes
H1	Conformity based on full quality assurance plus design examination	Design and production	As H, plus an EC design examination certificate	Yes

The NB number column follows the marking clauses of each module: the identification number appears next to the CE marking only when a notified body is involved in the production phase. Under B+C, the notified body has examined the design but not the production, so no number is affixed.

What Annex II says, module by module

Module A: internal production control

The manufacturer draws up the technical documentation, which must include "an adequate analysis and assessment of the risk(s)", a general description, design and manufacturing drawings, the list of harmonised standards applied in full or in part, design calculations and test reports (Annex II, module A, point 2). It takes the measures needed so that production matches the documentation, affixes the marking and keeps the declaration of conformity with the technical documentation for 10 years after the product has been placed on the market (point 4.2).

Module A does not require tests in an accredited laboratory. It requires test reports in the technical documentation where applicable; who produces them is the choice of the manufacturer, which remains solely responsible.

Module A is the only procedure under the LVD (Annex III) and RoHS (Article 7(b)). It is one of two options under EMC (Article 14) and one of three under the RED for Article 3(1), and for Article 3(2) and 3(3) when the cited harmonised standards are applied in full (Article 17).

Modules A1 and A2: supervised variants of A

A1 adds tests "for each individual product manufactured" on one or more specific aspects, carried out by an accredited in-house body or under the responsibility of a notified body chosen by the manufacturer. A2 adds product checks "at random intervals determined by the body", on an adequate sample taken on site before placing on the market, to verify the quality of the internal checks.

The Blue Guide (section 5.1.9) explains why these variants exist: they let the legislator rely on well-equipped manufacturer laboratories through an accredited in-house body. In practice A2 is used by the PED for category II equipment (Article 14(2)(b)). The RED, the EMC Directive and the Machinery acts use neither.

Module B: EC-type examination

The notified body examines the technical design in one of three ways (Annex II, module B, point 2): examination of a specimen of the complete product (production type), assessment of the documentation plus specimens of critical parts (combination), or assessment of the documentation without a specimen (design type). The manufacturer lodges the application with a single notified body, with a written declaration that it has not lodged it elsewhere (point 3).

The certificate contains "the conditions (if any) for its validity" (point 6). The Decision sets no validity period. The notified body must follow the state of the art and tell the manufacturer when the approved type may no longer comply (point 7). The manufacturer must inform the notified body of all modifications that may affect conformity or the conditions of validity; such modifications require additional approval in the form of an addition to the certificate (point 7).

B always comes with a production module. The Blue Guide (section 5.1.5) adds that the production-module certificate must be dated later than the B certificate, and both must exist before the first unit is placed on the market.

Modules C, C1 and C2: conformity to type

Under C, the manufacturer alone ensures that production conforms to the approved type. C1 adds tests on each product for specific aspects, as A1. C2 adds checks at random intervals on a sample, as A2; where a sample does not reach the acceptable quality level, the body takes appropriate measures.

Modules D and D1: production quality assurance

The manufacturer operates an approved quality system for production, final product inspection and testing. The notified body assesses it, carries out "periodic audits" and may pay "unexpected visits" during which it may test products (module D, points 4.3 and 4.4). The Decision fixes no audit frequency and no approval duration: those come from the sector act or the notified body contract. The MDR, for example, requires surveillance audits at least once every 12 months and unannounced audits at least once every five years (Annex IX, sections 3.3 and 3.4).

D1 has the same quality system but no type examination: the manufacturer also draws up the technical documentation and keeps it for 10 years. The Blue Guide (section 5.1.9) suggests D1, E1 and F1 for products of simple design but complicated manufacture.

Modules E and E1: product quality assurance

The quality system covers only final product inspection and testing. The Blue Guide describes E as "module D without the provisions relating to the manufacturing process", suited where the production mechanism is relatively simple. E1 is the variant without type examination.

Modules F and F1: product verification

At the choice of the manufacturer, the notified body examines and tests every product or a statistical sample of each homogeneous lot, issues a certificate of conformity and affixes its number. If a lot is rejected, it must not be placed on the market; frequent rejections allow the body to suspend statistical verification. The Blue Guide calls F "like C2 but the notified body carries out more systematic product checks" and F1 "like A2" with more detailed checks.

Module G: unit verification

The notified body examines and tests each individual product, issues a certificate of conformity and affixes its number. The Blue Guide (section 5.1.9) points to products made in small series.

Modules H and H1: full quality assurance

The quality system covers design, manufacture and final product inspection and testing, under periodic audits and possible unexpected visits. There is no type examination. Under the Blue Guide (section 5.1.6), applying EN ISO 9001 gives a presumption of conformity with the quality assurance modules for the provisions those standards cover, provided the quality system takes the specific products into account.

H1 adds a design examination: the notified body issues an "EC design examination certificate". The Blue Guide warns not to confuse it with the type-examination certificate of module B: under H1 there is no specimen, only a checked design. H1 is used by the PED for category IV and by the Lifts Directive (Annex XI).

Article by article: what each act allows

Dates checked on October 7, 2026 against the consolidated texts listed in the sources.

Act	Conformity article	Procedures allowed	Type-certificate validity
Directive 2014/35/EU (LVD)	Article 6(2), Annex III	Module A only; no notified body	Not applicable
Directive 2011/65/EU (RoHS)	Article 7(b)	Module A of Decision 768/2008	Not applicable
Directive 2014/30/EU (EMC)	Article 14	A (Annex II) or B+C (Annex III); B+C may be limited to some essential requirements, A covering the rest	Conditions, if any, stated on the certificate
Directive 2014/53/EU (RED)	Article 17	Article 3(1): A, B+C or H. Article 3(2) and 3(3): A, B+C or H if cited harmonised standards applied in full; otherwise B+C or H	Conditions, if any, stated on the certificate
Directive 2014/34/EU (ATEX)	Article 13	Categories M1 and 1: B+D or B+F. Categories M2 and 2: B+C1 or B+E for internal combustion engines and electrical equipment, otherwise A with the technical documentation sent to a notified body that retains it. Category 3: A. G is always an alternative. No module H	None required (ATEX Guidelines, paragraph 186)
Directive 2014/68/EU (PED)	Article 14	I: A. II: A2, D1, E1. III: B (design type)+D, B (design type)+F, B (production type)+E, B (production type)+C2, H. IV: B (production type)+D, B (production type)+F, G, H1. A higher-category procedure may always be chosen	10 years, renewable (Annex III, module B)
Directive 2014/33/EU (Lifts)	Articles 15 and 16	Safety components: B + random checking (Annex IX), B + product QA (Annex VI), full QA (Annex VII). Lifts: B or a QA-approved design followed by final inspection, product QA or production QA; unit verification (Annex VIII); full QA plus design examination (Annex XI)	Conditions, if any, stated on the certificate
Directive 2014/31/EU (NAWI)	Article 13	B+D or B+F; D1 or F1 for instruments without electronic devices and without a spring load-measuring device; G	10 years, renewable for 10-year periods (Annex II, module B)
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) plus internal checks, or full QA (Annex X). Otherwise: type examination or full QA	Review requested every five years (Annex IX, point 9.3)
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	At most five years (Annex VII)
Regulation 2017/745 (MDR)	Article 52	Class III: Annex IX, or Annex X with Annex XI. Classes IIb and IIa: Annex IX chapters I and III with technical documentation assessment, or the Annex X/XI or Annex XI routes set by Article 52. Class I: declaration, with a notified body for the sterile, measuring or reusable surgical aspects	At most five years, renewable (Article 56(2))
Regulation 2024/2847 (CRA)	Article 32	Default: A, B+C, H or a European cybersecurity certification scheme. Important class I without full harmonised standards, common specifications or scheme at level substantial: B+C or H. Important class II: B+C, H or a scheme at level substantial. Critical (Annex IV): a scheme under Article 8(1), otherwise the class II procedures	Conditions, if any, stated on the certificate
Regulation 2023/1542 (Batteries)	Article 17	Articles 6, 9, 10, 12, 13 and 14: A or D1 for series production, A or G otherwise. Articles 7 and 8 (carbon footprint, recycled content): D1 or G	Not applicable

Reading the table for a typical connected product (a mains-powered Wi-Fi or Bluetooth sensor): the RED covers its safety and EMC objectives through Article 3(1), and RoHS imposes module A. Module A is available for the whole product if the cited Article 3(2) and 3(3) harmonised standards are applied in full. Since August 1, 2025, Article 3(3)(d), (e) and (f) apply, and the EN 18031 series is cited with restrictions (Implementing Decision (EU) 2025/138): where a restriction bites, the standard is not applied in full for that requirement and Article 17(4) requires B+C or H.

Dated milestones

Date	Event	Source
July 22, 1993	Decision 93/465/EEC lays down the first modules	Decision 768/2008, recital 13
July 9, 2008	Decision 768/2008/EC and Regulation 765/2008 adopted; 93/465/EEC repealed	Decision 768/2008, Article 8
July 16, 2021	Market surveillance chapter of Regulation 765/2008 deleted, Regulation 2019/1020 applies	Regulation 2019/1020, Articles 39 and 44
June 29, 2022	Blue Guide 2022 published	OJ C 247, 29.6.2022
August 18, 2024	Battery conformity assessment (Article 17) applies, except Article 17(2)	Regulation 2023/1542, Article 96
August 1, 2025	RED Article 3(3)(d), (e) and (f) apply	Delegated Regulation (EU) 2022/30
June 11, 2026	CRA chapter IV (notification of conformity assessment bodies) applies	Regulation 2024/2847, Article 71
September 11, 2026	CRA reporting obligations (Article 14) apply	Regulation 2024/2847, Article 71
January 20, 2027	Machinery Regulation 2023/1230 applies, Directive 2006/42/EC repealed	Regulation 2023/1230, as corrected
December 11, 2027	CRA applies in full, including Article 32	Regulation 2024/2847, Article 71

Detailed case: ATEX 2014/34/EU

ATEX does not offer the full menu. Article 13(1) gives:

Categories M1 and 1 (very high level of protection, Annex I): EU-type examination (Annex III) with production quality assurance (Annex IV, module D) or product verification (Annex V, module F).
Categories M2 and 2 (high level of protection): for internal combustion engines and electrical equipment, EU-type examination with conformity to type plus supervised product testing (Annex VI, module C1) or product quality assurance (Annex VII, module E). For other equipment, internal production control (Annex VIII) and communication of the technical documentation to a notified body, which acknowledges receipt and retains it.
Category 3 (normal level of protection): internal production control (Annex VIII). No notified body.
Unit verification (Annex IX, module G) is always an alternative. Protective systems follow the category 1 route or G (Article 13(2)).

There is no module H in ATEX. See the ATEX guide for categories, marking and the international scheme.

Detailed case: MDR 2017/745

The MDR does not use the A to H labels, but its annexes follow the same logic: Annex IX (quality management system plus assessment of technical documentation) plays the role of a full quality assurance module, Annex X is an EU type-examination, and Annex XI is product conformity verification in two parts, Part A (production quality assurance) and Part B (product verification). Article 52 assigns them by class. Class I devices are self-declared, except that sterile devices, devices with a measuring function and reusable surgical instruments need a notified body for those aspects (Article 52(7)).

Decision path: choosing the procedure

Step 1. List every act that applies

A mains-powered radio product falls under the RED and RoHS; a product with digital elements will add the CRA from December 11, 2027; an industrial device for explosive atmospheres adds ATEX; a machine adds the Machinery Directive, then the Machinery Regulation. Where several acts apply, Article 4(2) of the Decision asks the legislator to keep their procedures consistent, but the manufacturer still has to satisfy each act and draw up a single declaration of conformity covering all of them (for example EMC Article 15(3), ATEX Article 14(3)).

Step 2. Read each conformity article

Open the article in the table above, not a summary. The procedures differ by act even where the module letters are the same: B+C1 exists in ATEX but not in the RED, A2 in the PED but not in the Machinery Regulation.

Step 3. Check harmonised standards coverage

Where the act makes module A conditional (RED Article 17(3) and (4), Machinery Regulation Article 25(3), CRA Article 32(2)), check that every relevant requirement is covered by a harmonised standard cited in the Official Journal and applied in full, including any restriction in the citation. See the self-declaration versus notified body guide and the CE procedure.

Step 4. Choose among the remaining procedures

Where several procedures remain, the choice is yours. The Blue Guide (section 5.1.9) gives the logic the legislator applied: G for small series, F or F1 where products are checked individually or by lot, D or E where a quality system can carry production, H where a quality system already covers design and production. Choose a notified body designated for that procedure under that act (NANDO selection guide).

Common pitfalls

Under-sizing the procedure

Keeping module A for a product that the act sends to a notified body (an ATEX category 1 or 2 electrical product, an MDR class IIa device, a CRA important class II product) leaves the declaration of conformity without the required basis.

Changing the approved type without telling the notified body

Annex II, module B, point 7 requires the manufacturer to inform the notified body of all modifications that may affect conformity or the conditions of validity; they need an addition to the certificate. See component substitution rules.

Forgetting that B is only half a procedure

A type-examination certificate does not cover production. The production module (C, C1, C2, D, E or F) and its certificate, where it has one, must be in place before the first unit is placed on the market (Blue Guide, section 5.1.5).

Ignoring quality system surveillance

Under D, D1, E, E1, H and H1 the notified body carries out periodic audits and may pay unexpected visits. An approval that is suspended or withdrawn no longer supports the declaration. See notified body surveillance audits.

Treating the certificate as a marketing authorisation

A type-examination or quality system certificate attests one step of conformity assessment. The manufacturer signs the declaration of conformity and remains responsible for the product (Blue Guide, section 5.1.3).

Claims the texts contradict

Claim	What the text says
"Annex II has eight modules and nine variants"	Eight modules and eight variants (A1, A2, C1, C2, D1, E1, F1, H1), giving 16 procedures (Blue Guide, sections 5.1.4 and 5.1.8)
"A1 means tests at random intervals, A2 checks at fixed intervals"	A1 and C1: supervised tests on specific aspects of each product. A2 and C2: checks at random intervals set by the body. No module sets fixed intervals (Decision 768/2008, Annex II)
"ATEX category 2: B+C1, B+E, B+F or H"	B+C1 or B+E, and only for internal combustion engines and electrical equipment; other category 2 equipment uses Annex VIII plus the file sent to a notified body. Module H does not exist in ATEX (Directive 2014/34/EU, Article 13(1)(b))
"ATEX category 3: module A with the technical file lodged with a notified body"	Category 3 is internal production control only; lodging the file applies to non-electrical category 2 equipment (Article 13(1)(b)(ii) and (c))
"Type certificates last five years under the RED and ten years under ATEX"	Neither directive sets a period; the certificate states its conditions of validity, if any (RED Annex III point 6; ATEX Guidelines, paragraph 186). The PED and the NAWI Directive set 10 years, the Machinery Regulation and the MDR at most five
"RED module A requires every Article 3(1), 3(2) and 3(3) standard to be applied in full"	Article 3(1) can always use A, B+C or H (Article 17(2)); the harmonised standards condition applies to Article 3(2) and 3(3) only (Article 17(3) and (4))
"The Batteries Regulation offers A, B+C, B+D or H"	Article 17 offers A, D1 and G only
"Module A requires tests in an accredited laboratory"	Module A requires test reports in the technical documentation where applicable; it does not say who performs the tests
"QMS approval lasts three years with annual audits"	Decision 768/2008 requires "periodic audits" and allows unexpected visits; periods come from the sector act, for example at least every 12 months under the MDR (Annex IX, section 3.3)
"Every MDR device above class I needs a notified body, class I never does"	Class I sterile, measuring and reusable surgical devices also need a notified body for those aspects (MDR Article 52(7))
"Annex IV of the Decision sets the CE marking rules"	The Decision has three annexes; the CE marking rules are Articles R11 and R12 of Annex I, which refer to Article 30 of Regulation 765/2008

Articulation with Regulation 765/2008, Regulation 2019/1020 and the Blue Guide

Decision 768/2008 supplies the modules and the reference provisions that sector acts copy. Regulation 765/2008 now covers accreditation, which national authorities may use to assess notified bodies, and the general principles of the CE marking (Article 30). Market surveillance of products is governed by Regulation 2019/1020 since July 16, 2021. The Blue Guide 2022 is the Commission guidance on how these texts apply together; it is not legally binding, but chapter 5 is the clearest single account of the modules.

See the CE pillar for the overview of the marking and the glossary for definitions of NLF terms such as attestation and DoC.

Frequently asked questions

What is Decision 768/2008/EC and why is it called horizontal?: Decision No 768/2008/EC of 9 July 2008 sets a common framework for the marketing of products. Its Annex II lays down the conformity assessment modules A to H and their variants. It binds no manufacturer directly: Article 4 says that where Union harmonisation legislation requires conformity assessment, the procedures are chosen from the Annex II modules. Each sector act (RED, EMC, ATEX, PED, Machinery, MDR, CRA) then lists which procedures apply to its products. The Decision repealed Decision 93/465/EEC.
How many modules and procedures are there?: Eight modules, named A to H, of which six have variants: A1, A2, C1, C2, D1, E1, F1 and H1. The Blue Guide 2022 (section 5.1.8) counts 16 possible procedures, because module B is never used alone: it is always followed by C, C1, C2, D, E or F.
What is the difference between module B and module C?: Module B (EC-type examination, EU-type examination in the sector acts) covers design: a notified body examines the technical design and, depending on the variant, a specimen, and issues a type-examination certificate. Module C covers production: the manufacturer ensures, under its own internal production control, that each unit conforms to the approved type, with no further notified body involvement. B is always paired with a production module.
What is the difference between modules D, E and H?: All three rest on a quality system approved and audited by a notified body. Under module D the quality system covers production, final product inspection and testing. Under module E it covers only final product inspection and testing. Under module H it covers design, manufacture and final product inspection and testing, with no type examination. D and E follow module B; H does not.
Do A1 and A2 mean tests at random and at fixed intervals?: No. In Annex II, A1 (and C1) means supervised product testing: tests on specific aspects of each product, carried out by an accredited in-house body or under the responsibility of a notified body. A2 (and C2) means supervised product checks at random intervals determined by the body, on a sample taken before placing on the market. No module in Annex II sets fixed intervals.
How long is an EU-type examination certificate valid?: Decision 768/2008 sets no period: the certificate states the conditions, if any, for its validity. Some sector acts fix one: 10 years renewable under the PED and the NAWI Directive, at most five years under the Machinery Regulation 2023/1230 and the MDR. The RED, the EMC Directive, the CRA and ATEX set none (ATEX Guidelines, paragraph 186).
Does the RED allow module A for every product?: For the Article 3(1) requirements (safety and EMC), yes: Article 17(2) allows module A, B+C or H whatever the standards used. For Article 3(2) and 3(3), module A is only available when harmonised standards cited in the Official Journal have been applied in full. If they were not applied, applied in part, or do not exist, Article 17(4) requires B+C or H for those requirements.
Which documents does each module produce?: In every module the manufacturer draws up the declaration of conformity and keeps it, with the technical documentation, for 10 years after placing on the market unless the sector act alters the period. Module B produces a type-examination certificate, H1 an EC design examination certificate, D, D1, E, E1, H and H1 a quality system approval with audit reports, and F, F1 and G a certificate of conformity from the notified body.