- CE
- CE marking procedure: modules and steps, by the texts
CE marking procedure: modules and steps, by the texts
The CE procedure is written into the texts: each sectoral act lists the conformity assessment procedures it allows, taken from the modules of Decision 768/2008/EC, and sets the order of the manufacturer obligations: technical documentation, assessment, EU declaration of conformity, then CE marking. This page follows that order for a typical electronic product, with the article behind each step, as of 7 October 2026. It gives no durations or costs: the texts set none, and they depend on the product and the laboratories. What the texts do settle is who must act, in what order, and when a third party is required, along with the chain of economic operators behind the product.
TL;DR:
- The act chooses the module, not the manufacturer alone. LVD and RoHS: module A only. EMC: A or B+C. RED: A, B+C or H, with module A for Article 3(2) and 3(3) only when the cited harmonised standards are applied in full.
- The order is fixed by the articles: the DoC is drawn up and the CE marking affixed only once compliance "has been demonstrated" by the procedure (EMC Article 7(2), LVD Article 6(2), RED Article 10(3)).
- No accredited laboratory is required under module A; the texts require test reports in the file, not a particular laboratory.
- The NB number follows the CE marking only when the body is involved in production (Decision 768/2008 Article R12(3)); under RED, only for module H.
- Since 16 July 2021 a product under these acts needs an economic operator established in the EU (Regulation 2019/1020 Article 4).
The procedure step by step, with the text behind each step
Section titled “The procedure step by step, with the text behind each step”For a product under several acts, each step is done once for all of them where the texts allow it (one technical documentation for RoHS within another procedure, one DoC for all acts).
| # | Step | What the text requires | Text |
|---|---|---|---|
| 1 | Identify the acts | CE marking only where an act provides for it; a radio product falls under RED, which excludes the LVD (except through Article 3(1)(a)) and the EMC Directive | Regulation 765/2008 Article 30(2); RED Article 1(4); EMC Article 2(2)(a) |
| 2 | Analyse the risks | The technical documentation includes "an adequate analysis and assessment of the risk(s)"; the manufacturer remains responsible for identifying the relevant requirements even when using harmonised standards | Decision 768/2008 Annex II, module A point 2; Blue Guide 2022, section 4.1.2.2 |
| 3 | Choose the standards | Cited harmonised standards give presumption of conformity for the requirements they cover; other solutions are allowed but must be demonstrated in the file | EMC Article 13; LVD Article 12; RED Article 16; Blue Guide 2022, section 4.1.3 |
| 4 | Choose the procedure | Among those the act allows (table below) | EMC Article 14; LVD Article 6(2) and Annex III; RED Article 17; RoHS Article 7(b) |
| 5 | Test, and involve a notified body where required | Test reports in the file; notified body only for the modules that require one | Module A point 2; EMC Annex III; RED Annexes III and IV |
| 6 | Draw up the technical documentation | Contents set by each annex; available when the product is placed on the market | EMC Annex II; LVD Annex III; RED Article 21 and Annex V; Blue Guide 2022, section 4.3 |
| 7 | Draw up the EU declaration of conformity | Once compliance has been demonstrated; one DoC for all acts that require one, with their publication references | EMC Articles 7(2) and 15; LVD Articles 6(2) and 15; RED Articles 10(3) and 18 |
| 8 | Affix the CE marking and the identification details | Before placing on the market; type, batch or serial number; manufacturer name and postal address | EMC Articles 7(5), 7(6) and 17; LVD Articles 6(5), 6(6) and 17; RED Articles 10(6), 10(7), 19 and 20; RoHS Article 15 |
| 9 | Provide instructions and safety information | In a language easily understood by end users, as determined by the Member State; for radio equipment, frequency bands, maximum power, and a DoC copy or simplified DoC | EMC Article 7(7); LVD Article 6(7); RED Article 10(8) to (10) |
| 10 | Make sure an EU economic operator is responsible | Manufacturer, importer, authorised representative or fulfilment service provider established in the EU, named on the product, packaging, parcel or an accompanying document | Regulation 2019/1020 Article 4 |
| 11 | Keep production and the file in conformity | 10-year retention; series production kept in conformity; corrective action and information of authorities when non-compliance is found | EMC Article 7(3), (4) and (8); LVD Article 6(3), (4) and (8); RED Article 10(4), (5) and (11) |
Steps 1 to 3 are detailed in Scope and Standards, steps 5 and 6 in Tests and Technical file, and the errors that occur at each step in Common pitfalls.
Which procedures each act allows
Section titled “Which procedures each act allows”Decision 768/2008/EC defines eight modules, A to H, and eight variants (A1, A2, C1, C2, D1, E1, F1, H1). It binds no manufacturer directly: each act picks its procedures from that list. For the four acts that cover most electronic products:
| Act | Procedures allowed | Notified body | Article |
|---|---|---|---|
| Directive 2014/35/EU (LVD) | Module A (internal production control) | Never: "There is no conformity assessment procedure in this Directive which requires the intervention of a notified body" (recital 36) | Article 6(2), Annex III |
| Directive 2011/65/EU (RoHS) | Module A; may be done within the procedure of another act at least as stringent, with a single technical documentation | Never | Article 7(b) and (c) |
| Directive 2014/30/EU (EMC) | Module A (Annex II), or EU-type examination followed by conformity to type, B+C (Annex III); B+C may be limited to some aspects, A covering the rest | Only if the manufacturer chooses B+C | Article 14 |
| Directive 2014/53/EU (RED), Article 3(1), and 3(4) as added by Directive (EU) 2022/2380 | A (Annex II), B+C (Annex III) or H (Annex IV) | Only if the manufacturer chooses B+C or H | Article 17(2) |
| RED, Article 3(2) and activated points of 3(3) | A, B+C or H if cited harmonised standards are applied in full; otherwise B+C or H | Required when standards are not applied, applied in part, or do not exist | Article 17(3) and (4) |
What the modules mean in these acts:
- Module A: the manufacturer draws up the technical documentation, ensures production stays in conformity, draws up the DoC and affixes the CE marking. No third party is involved. Module A does not say who performs the tests.
- Modules B + C: under the EMC Directive and RED, the notified body examines the technical documentation "without examination of a specimen (design type)" (EMC Annex III point 2; RED Annex III point 2) and issues an EU-type examination certificate. Under module C the manufacturer then ensures production conforms to the approved type, with no further body involvement. The certificate states "the conditions (if any) for its validity"; neither directive sets a period.
- Module H (RED only among these acts): a notified body approves and audits the manufacturer quality system for design, manufacture, final inspection and testing (Annex IV), with "periodic audits" at no set frequency.
Modules A1, A2, C1, C2, D, D1, E, E1, F, F1, G and H1 exist in Decision 768/2008 but none of these four acts uses them. They appear in other acts (for example ATEX, the Pressure Equipment Directive, the NAWI Directive or the Machinery Regulation). The modules A to H guide gives the act-by-act table, and the RED procedure reads Annexes II to IV in detail.
When a notified body is required
Section titled “When a notified body is required”For the acts above, the cases are narrow:
| Situation | Notified body? | Basis |
|---|---|---|
| Electrical safety under the LVD, with or without harmonised standards | No | LVD Article 6(2), recital 36 |
| EMC, with or without harmonised standards | No, unless the manufacturer chooses B+C | EMC Article 14 |
| RED Article 3(1)(a) safety or 3(1)(b) EMC | No, unless the manufacturer chooses B+C or H | RED Article 17(2) |
| RED Article 3(2) radio, no cited standard for the band or technology, or a cited standard applied only in part | Yes, B+C or H | RED Article 17(4) |
| RED Article 3(3)(d), (e) or (f) for equipment under Delegated Regulation (EU) 2022/30, where an EN 18031 restriction applies or EN 18031 is not applied | Yes, B+C or H | RED Article 17(4); Implementing Decision (EU) 2025/138 |
| A sector act that requires a body for a risk category (for example ATEX equipment categories M1 and 1, machinery in Annex I of Regulation 2023/1230 from 20 January 2027, most medical devices above class I) | As set by that act | ATEX Article 13; Regulation 2023/1230 Article 25; MDR Article 52 |
A manufacturer that does not apply a harmonised standard is not, for that reason alone, sent to a notified body under the EMC Directive or the LVD: it must demonstrate conformity by other means in its technical documentation (Blue Guide 2022, section 4.1.3). The requirement is specific to the acts that write it, such as RED Article 17(4).
Finding a notified body
Section titled “Finding a notified body”Notified bodies are listed in the Commission NANDO database (Single Market Compliance Space), by act, by procedure and by scope. A body notified for one act or one procedure is not thereby notified for another, so check the act, the annex (for example RED Annex III or IV) and the requirements or equipment covered. The notified body selection guide explains how to read a notification. A body may use its number only for the conformity assessment activities it is notified for (Blue Guide 2022, section 5.2.2).
A worked sequence: a Wi-Fi and BLE sensor under module A
Section titled “A worked sequence: a Wi-Fi and BLE sensor under module A”A mains-powered sensor with Wi-Fi and BLE, sold to consumers, with internet connectivity:
- Acts. RED, because the product intentionally emits radio waves; RoHS. The EMC Directive and the LVD do not apply separately: RED covers safety through Article 3(1)(a) with no voltage limit, and EMC through Article 3(1)(b). Because it is internet-connected, Delegated Regulation 2022/30 makes Article 3(3)(d) apply from 1 August 2025, and 3(3)(e) if it processes personal, traffic or location data. Ecodesign or other acts are checked separately. See Scope.
- Risk analysis and configurations. Every intended operating condition and every configuration the product can take (RED Article 17(1)), plus reasonably foreseeable conditions for safety.
- Standards. For Article 3(2), the editions cited in the RED list on the day of signature; for Article 3(3), EN 18031-1 and, if relevant, EN 18031-2, checked against the restrictions of Decision 2025/138. Safety and RF exposure standards such as EN 62368-1 are used as other technical specifications for Article 3(1)(a), since the RED list cites no general safety standard. See Standards.
- Procedure. Module A for the whole product if the cited standards for 3(2) and 3(3) are applied in full and no restriction applies; otherwise B+C or H for those requirements, while 3(1) stays under module A if the manufacturer wishes.
- Tests. In the laboratory of the manufacturer's choice under module A. See Tests.
- Technical documentation to RED Annex V, with the RoHS evidence (EN IEC 63000:2018). See Technical file.
- One DoC covering RED and RoHS, with their publication references (RED Article 18(3)), signed once the reports exist.
- Marking on the product or its data plate and on the packaging (RED Article 20(1)), with type or serial number, manufacturer name and postal address, and the Article 4 operator details.
- Accompanying information: instructions and safety information in the language required by each Member State, frequency bands and maximum transmitted power, a copy of the DoC or the simplified DoC of Annex VII, and the Article 10(10) information if use is restricted in some Member States.
CE marking: what the texts fix
Section titled “CE marking: what the texts fix”| Rule | Text |
|---|---|
| Affixed only by the manufacturer or its authorised representative | Regulation 765/2008 Article 30(1) |
| Only on products whose act provides for it, and on no other product | Regulation 765/2008 Article 30(2) |
| Form of the graduated drawing; proportions kept if reduced or enlarged | Regulation 765/2008 Annex II points 1 and 2 |
| At least 5 mm high where the act imposes no other dimension | Regulation 765/2008 Annex II point 3 |
| Radio equipment: may be lower than 5 mm "provided that it remains visible and legible" | RED Article 19(2) |
| On the product or its data plate, "visibly, legibly and indelibly"; on the packaging and accompanying documents only where that is not possible or not warranted by the nature of the product | EMC Article 17(1); LVD Article 17(1); RoHS Article 15(1) |
| Radio equipment: also on the packaging, in every case | RED Article 20(1) |
| Affixed before placing on the market | EMC Article 17(2); LVD Article 17(2); RED Article 20(2) |
| Notified body number after the CE marking only where the body is involved in the production control phase | Decision 768/2008 Article R12(3); Blue Guide 2022, section 4.5.1.5 |
| Radio equipment: NB number only under module H, same height as the CE marking | RED Article 20(3) |
| No markings likely to mislead about the meaning or form of the CE marking | Regulation 765/2008 Article 30(5) |
The Blue Guide (section 4.5.1.4) adds that the marking may not be moved from the product to the packaging "on purely aesthetic grounds", that it may be hollow or coloured if proportions and legibility are kept, and that electronic labelling alone is not allowed. The RED Guide notes that the reduced RED height cannot be used where another applicable act, such as RoHS, does not allow it. Graphic details: CE marking dimensions and visual rules.
There is no separate "China Export" mark to tell apart from the CE marking. Answering written question P-5938/2007 in March 2008, the Commission said it was not aware of any "China export mark" and considered the mark in question to be the CE marking affixed without respecting the prescribed dimensions and proportions. A marking that departs from the graduated drawing is a formal non-compliance, which the authority requires the operator to end, and which can lead to restriction, withdrawal or recall if it persists (EMC Article 40, LVD Article 22, RED Article 43).
Modifications after placing on the market
Section titled “Modifications after placing on the market”The texts give no list of "modification types". They give three rules:
- Series production. Changes in design or characteristics, and changes in the harmonised standards or other specifications on which conformity is declared, "shall be adequately taken into account" (EMC Article 7(4), LVD Article 6(4), RED Article 10(5)).
- Type certificates. Under module B, the manufacturer informs the notified body of every modification of the approved type that may affect conformity; it needs an addition to the certificate (EMC Annex III and RED Annex III, point 7).
- New product. The Blue Guide (section 2.1) treats a modified product as a new product when its original performance, purpose or type is modified without this being foreseen in the initial risk assessment, the nature of the hazard has changed or the level of risk has increased, and the product is made available. The same test applies to software updates. The person making such a change becomes the manufacturer. The documentation is updated "in as much as the modification has an impact", and tests on unaffected aspects need not be repeated.
Each change and its assessment go into the technical documentation, and the DoC is updated for units placed on the market after it. Practical cases (antenna, power supply, firmware): Component substitution rules.
Economic operators: who does what
Section titled “Economic operators: who does what”The obligations below are those of the sectoral acts (EMC Articles 7 to 12, LVD Articles 6 to 11, RED Articles 10 to 15, following Decision 768/2008 Articles R2 to R7). Regulation 2019/1020 adds the Article 4 operator on top of them; it does not replace them.
| Operator | Main obligations | Text |
|---|---|---|
| Manufacturer | Design to the essential requirements, technical documentation, procedure, DoC, CE marking, identification and contact details, instructions, 10-year retention, corrective action | EMC Article 7; LVD Article 6; RED Article 10 |
| Authorised representative | Only the tasks of a written mandate, at least: keep the DoC and file 10 years, provide information on reasoned request, cooperate with authorities. Cannot be given the design obligations or drawing up the technical documentation | EMC Article 8; LVD Article 7; RED Article 11 |
| Importer | Before placing on the market: check that the procedure was carried out, the file drawn up, the CE marking, documents and manufacturer details present; add its own name and postal address; keep a copy of the DoC 10 years | EMC Article 9; LVD Article 8; RED Article 12 |
| Distributor | Before making available: verify the CE marking, the documents, the instructions in the right language, and the manufacturer and importer details; do not supply a product it believes non-compliant; inform where there is a risk | EMC Article 10; LVD Article 9; RED Article 13 |
| Importer or distributor treated as manufacturer | When it places the product on the market under its own name or trade mark, or modifies it so that compliance may be affected | EMC Article 11; LVD Article 10; RED Article 14 |
| All operators | Identify, on request, who supplied them and whom they supplied, for 10 years | EMC Article 12; LVD Article 11; RED Article 15 |
| Article 4 operator (EU manufacturer, importer, authorised representative or fulfilment service provider) | Verify the DoC and file exist, keep the DoC available, answer reasoned requests, inform authorities of a risk, cooperate on corrective action; name and contact details on the product, packaging, parcel or accompanying document | Regulation 2019/1020 Articles 4 and 5 |
A manufacturer established outside the Union is not obliged by these acts to appoint an authorised representative (Blue Guide 2022, section 3.2), but where it has no EU importer, it needs one of the Article 4 operators. The Blue Guide also lists, among the tasks a mandate may include, affixing the CE marking and drawing up and signing the DoC. Online offers targeted at end users in the Union count as making the product available (Article 6); online platforms must cooperate with authorities at their request (Article 7(2)). Detail: Authorised representative and importer obligations.
At the external border, customs suspend release for free circulation when, among other cases, the required documentation is missing, the CE marking is affixed in a false or misleading manner, or the Article 4 operator details are not indicated (Regulation 2019/1020 Article 26(1)). Penalties are set by each Member State and must be "effective, proportionate and dissuasive" (Article 41; LVD Article 24, which allows criminal penalties for serious infringements).
Dates that shaped the procedure
Section titled “Dates that shaped the procedure”| Date | Act | Effect |
|---|---|---|
| 9 July 2008 | Decision 768/2008/EC, Regulation (EC) No 765/2008 | Common modules, reference obligations of operators, CE marking principles |
| 20 April 2016 | Directives 2014/30/EU and 2014/35/EU | EMC and LVD recasts apply; Directives 2004/108/EC and 2006/95/EC repealed |
| 13 June 2016 | Directive 2014/53/EU | RED applies; Directive 1999/5/EC repealed |
| 16 July 2021 | Regulation (EU) 2019/1020 | Article 4 EU operator required; customs controls of Articles 25 to 28 |
| 29 June 2022 | Blue Guide 2022 (OJ C 247) | Current Commission guidance on modules, marking and operators |
| 1 August 2025 | Delegated Regulation (EU) 2022/30 | RED Article 3(3)(d), (e) and (f) apply to the categories it lists |
| 11 September 2026 | Regulation (EU) 2024/2847 (CRA) | Reporting obligations apply |
| 20 January 2027 | Regulation (EU) 2023/1230 | Machinery Regulation applies, with its own procedures (Article 25) |
| 11 December 2027 | Regulation (EU) 2024/2847 (CRA) | Full application, with its own conformity assessment (Article 32) |
Claims the texts contradict
Section titled “Claims the texts contradict”Several of these claims appeared on an earlier version of this page.
| Common claim | What the text says |
|---|---|
| "If a harmonised standard is not fully applied, a notified body is mandatory" | True only where an act says so (RED Article 17(4) for 3(2) and 3(3)). Under the LVD no procedure involves a body, and under the EMC Directive module A stays open; conformity is then demonstrated in the file (Blue Guide 2022, section 4.1.3) |
| "Module A is reserved for products whose harmonised standards are fully applied" | That condition exists only for RED Article 3(2) and 3(3). LVD Annex III and EMC Article 14 do not make module A conditional on standards |
| "Under module B the notified body examines a representative sample" | EMC and RED Annex III point 2: design-type examination, "without examination of a specimen" |
| "The NB number appears next to the CE marking whenever a body has intervened" | Only where the body is involved in the production control phase (Article R12(3)); under RED only for module H (Article 20(3)) |
| "For EMC, risk analysis is good practice but not mandatory" | EMC Annex II point 3 requires "an adequate analysis and assessment of the risk(s)", as module A does for every act |
| "Tests must be done in an ISO/IEC 17025 accredited laboratory" | Module A requires test reports in the file and does not say who performs the tests |
| "The authorised representative does not sign the DoC" | The Blue Guide (section 3.2) lists drawing up and signing the DoC among the tasks a written mandate may include |
| "Every non-EU manufacturer must appoint an authorised representative" | Not required by the sectoral acts (Blue Guide 2022, section 3.2); Regulation 2019/1020 Article 4 requires an EU operator, which may be the importer |
| "Online platforms must refuse listings without an EU operator" | Article 7(2) requires platforms to cooperate with authorities at their request and in specific cases |
| "Regulation 2019/1020 defines the importer and distributor obligations" | Those obligations are in the sectoral acts (for example EMC Articles 9 and 10); the Regulation adds the Article 4 operator and market surveillance |
| "An importer that skips its checks becomes the manufacturer" | It becomes the manufacturer when it places the product under its own name or trade mark or modifies it so that compliance may be affected (EMC Article 11, LVD Article 10, RED Article 14) |
| "An LTE or 5G product goes through a notified body" | RED Article 17 depends on whether cited harmonised standards are applied in full, not on the radio technology |
| "China Export is a look-alike mark that a trained eye can tell from CE" | The Commission knew of no such mark and read it as a CE marking with the wrong dimensions and proportions (answer to P-5938/2007), a formal non-compliance under EMC Article 40, LVD Article 22 and RED Article 43 |
| "Module D, E, F or G can be used for an electronic product under EMC, LVD or RED" | Not in these acts: LVD A; EMC A or B+C; RED A, B+C or H |
See also
Section titled “See also”- Choosing a Notified Body, NANDO and scope verification: how to verify an NB's notified scope before engaging it.
- NB surveillance audits, cadence and conduct: what to expect after the type examination certificate.
- EU Authorised Representative and Importer obligations: the economic operator chain required since Regulation 2019/1020.
- Certification test plan, template and checklist: the TPP structure that feeds the assessment module.
- Product recall and EU Safety Gate response procedure: the corrective action procedure that closes the certification loop.
- Conformity assessment modules A to H: the 16 procedures of Decision 768/2008 and what every act allows.
- Self-declaration or notified body: the decision across CE acts.
- EU declaration of conformity: content, signature and languages of the DoC.
- RED procedure: Article 17 and Annexes II to IV for radio equipment.
Sources & references
- Decision No 768/2008/EC, Articles R2 to R12 and Annex II (modules), EUR-Lex eur-lex.europa.eu/eli/dec/2008/768/oj
- Regulation (EC) No 765/2008, Article 30 and Annex II (CE marking), EUR-Lex eur-lex.europa.eu/eli/reg/2008/765/oj
- Directive 2014/30/EU (EMC), Articles 7 to 19 and Annexes II and III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/30/oj
- Directive 2014/35/EU (LVD), Articles 6 to 17 and Annex III, EUR-Lex eur-lex.europa.eu/eli/dir/2014/35/oj
- Directive 2014/53/EU (RED), Articles 1(4), 10 to 21 and Annexes II to IV, EUR-Lex eur-lex.europa.eu/eli/dir/2014/53/oj
- Directive 2011/65/EU (RoHS), Articles 7 and 15, EUR-Lex eur-lex.europa.eu/eli/dir/2011/65/oj
- Regulation (EU) 2019/1020 on market surveillance, Articles 4 to 7, 26 to 28, 41 and 44, EUR-Lex eur-lex.europa.eu/eli/reg/2019/1020/oj
- The Blue Guide on the implementation of EU product rules 2022 (2022/C 247/01), sections 2.1, 3.2, 4.1, 4.3, 4.5.1, 5.1 and 5.2, EUR-Lex eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022XC0629(04)
- Guide to the Radio Equipment Directive 2014/53/EU, European Commission ec.europa.eu/docsroom/documents/33162
- 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
- Answer given on behalf of the Commission to written question P-5938/2007 (China Export mark), European Parliament www.europarl.europa.eu/doceo/document/P-6-2007-5938-ASW_EN.html
- NANDO: notified bodies database (Single Market Compliance Space), European Commission webgate.ec.europa.eu/single-market-compliance-space/#/notified-bodies
Frequently asked questions
- Which conformity assessment module applies to a typical electronic product?
- It depends on the act, not on the product family. The LVD offers module A only (Article 6(2) and Annex III) and RoHS imposes module A (Article 7(b)). The EMC Directive offers module A or modules B and C (Article 14). RED offers A, B+C or H for Article 3(1), and for Article 3(2) and 3(3) module A only when cited harmonised standards are applied in full (Article 17). Modules D, E, F and G are not available under these four acts.
- When is a notified body mandatory for CE marking?
- Under the LVD and RoHS, never: the LVD states that none of its procedures requires one. Under the EMC Directive, only if the manufacturer chooses modules B and C. Under RED, for Article 3(2) and 3(3) when the cited harmonised standards are not applied, applied only in part, or do not exist (Article 17(4)). Other acts, such as ATEX, machinery in Annex I of Regulation 2023/1230 or the medical device regulations, set their own cases.
- Does the notified body number always follow the CE marking?
- No. Decision 768/2008 Article R12(3) puts it after the CE marking only where the body is involved in the production control phase. The Blue Guide 2022 states that a body involved only under module B does not add its number. Under RED, Article 20(3) limits the number to module H.
- Must a non-EU manufacturer appoint an authorised representative?
- The sectoral acts do not require it: the Blue Guide 2022 states that a manufacturer established outside the Union is not obliged to have one. Since 16 July 2021, however, Article 4 of Regulation (EU) 2019/1020 requires an economic operator established in the Union (manufacturer, importer, authorised representative with a written mandate, or fulfilment service provider) for products under the EMC Directive, the LVD, RED, RoHS and the other acts it lists.
- Does a product change require a new conformity assessment?
- The texts set no list of cases. The manufacturer must take changes in design, characteristics and standards adequately into account (EMC Article 7(4), LVD Article 6(4), RED Article 10(5)), and a type covered by an EU-type examination certificate needs an addition to it when the change may affect conformity. The Blue Guide 2022 treats a modified product as new when its performance, purpose or type changes beyond the initial risk assessment and the hazard or risk level changes.