Self-Declaration of Conformity

Self-Declaration of Conformity — Manufacturer’s EU Compliance Route

Self-declaration of conformity is an informal description of a route in which the manufacturer assesses its product’s conformity without mandatory involvement of a notified body, where the applicable EU legislation permits this. Module A (internal production control) is one such procedure; sector-specific procedures may use different names.

The manufacturer must demonstrate compliance, prepare the required technical documentation and issue the applicable declaration of conformity. An EU Declaration of Conformity is also required under many procedures involving a notified body: issuing a declaration does not, by itself, mean that a product is eligible for self-assessment. [Sources: Decision 768/2008/EC, Annex II; Blue Guide, sections 4.4 and 5.]

Reviewed: 2 October 2026. The CRA and machinery transition dates below distinguish current requirements from future conformity assessment obligations.

Key Facts

Detail	Information
Eligibility	Determined by every applicable product law, the product category and the conditions of the assessment procedure
Typical procedure	Module A, where provided for; other sectors have their own procedures
Responsible party	The manufacturer; an authorised representative may perform only tasks permitted by the legislation and its written mandate
Notified body	Not mandatory for a permitted self-assessment route; may be mandatory under another law applying to the same product
Test laboratory	Internal or external evidence may be used, as appropriate; accreditation is not a general requirement of Module A
Output	Required technical documentation, the applicable declaration of conformity and CE marking where the legislation requires it
GPSR	A separate general product safety framework; it does not itself establish CE marking or an EU Declaration of Conformity

How Self-Declaration of Conformity Works

Step 1: Identify Applicable Directives and Regulations

Determine the product’s intended use, characteristics and regulatory classification before selecting an assessment route. For a Wi-Fi product that qualifies as radio equipment:

RED (2014/53/EU) covers radio spectrum requirements, safety and electromagnetic compatibility, plus additional requirements where applicable.
RoHS (2011/65/EU) may also apply, subject to its scope and exclusions.
Other product-specific legislation may apply to the finished product.

Do not automatically list LVD and the EMC Directive as separate applicable directives for the radio equipment itself. RED incorporates their safety and EMC objectives; its safety requirements apply without a voltage limit. A separately supplied power supply or another distinct product can have its own applicable legislation. [Sources: RED, Articles 1(4) and 3(1); Commission RED Guide, section 9.]

For consumer products, assess any additional GPSR (EU) 2023/988 obligations within its scope. For products covered by EU harmonisation legislation, GPSR applies subject to Article 2’s limits and exclusions. It is not an additional CE conformity assessment module.

Step 2: Select the Assessment Route and Relevant Standards

For the legislation discussed here, harmonised standards are generally voluntary. Compliance with the relevant provisions of a standard whose reference is published in the Official Journal provides a presumption of conformity only for the requirements it covers, subject to any published restrictions. Check the precise standard version, covered requirements and dates.

Alternative technical solutions can demonstrate compliance, but must be justified in the technical documentation. Choosing them can change the permitted assessment route: under RED Article 17(3)–(4), failure to apply, or only partial application of, the relevant harmonised standards for Article 3(2) or applicable Article 3(3) requirements requires EU-type examination followed by conformity to type (B+C), or full quality assurance (H). This rule does not apply in the same way to RED’s Article 3(1) safety and EMC requirements.

Step 3: Obtain Appropriate Technical Evidence

Demonstrate that the product meets the applicable legal requirements. Depending on the product and assessment procedure, evidence can include tests, engineering calculations, risk assessments, design reviews and relevant supplier documentation. Perform the tests required by the applicable procedure and selected compliance method.

Tests may be performed internally or commissioned from a competent external laboratory where the procedure permits. An accredited laboratory can provide useful independent evidence; a laboratory test report does not replace the manufacturer’s assessment or any mandatory notified-body procedure. Accreditation must cover the relevant testing if it is relied upon.

The manufacturer remains responsible for product conformity when it uses external services. This does not determine or exclude a laboratory’s separate contractual or legal liability. [Sources: Decision 768/2008/EC, Module A; LVD, Annex III; Blue Guide, section 3.1.]

Step 4: Compile and Maintain the Technical Documentation

The exact contents depend on the applicable legislation. For electronic hardware, the file will normally document the product and intended use, applicable requirements, risk assessment, design and manufacturing information, standards or alternative solutions, and relevant calculations and test reports. Include the declaration and other documents where required by the relevant law.

Retention periods are law-specific. RED, LVD, EMC and RoHS generally require ten years after the individual product is placed on the market. Keeping the common documentation for a model until ten years after its final unit is placed on the market covers that model’s last unit. Longer periods can apply: MDR requires at least fifteen years for implantable devices after the last device covered by the declaration is placed on the market; CRA Article 13(13), once applicable, requires at least ten years or the support period, whichever is longer.

Manufacturing controls must ensure that series production remains compliant. Reassess relevant changes to the product, manufacturing process and compliance basis, and update the documentation and declaration where necessary. [Sources: Blue Guide, sections 3.1 and 4.3; applicable sector legislation.]

Step 5: Issue the Declaration of Conformity

Use the declaration structure required by the applicable product legislation. It generally identifies the manufacturer and product, states the manufacturer’s sole responsibility, identifies the applicable legal acts and standards or other technical specifications used, and includes the authorised signatory’s details and signature. Include notified-body and certificate details where applicable.

Provide translations into the language or languages required by the Member States where the product is marketed. One official EU language is not automatically sufficient for all markets. Under RED, the product must be accompanied by a full DoC or a simplified declaration giving the exact web address of the full text. [Sources: RED, Articles 10(9) and 18; Your Europe guidance.]

Step 6: Affix the CE Mark Correctly

Complete the required assessment and documentation and meet the declaration and marking obligations before placing the product on the market. CE marking is normally placed visibly, legibly and indelibly on the product or its data plate. Moving it to packaging or accompanying documents is subject to the conditions in the relevant legislation. For RED equipment, CE marking must also appear on the packaging. [Sources: RED, Article 20; Blue Guide, section 4.5.1.4.]

Self-Declaration vs. Notified-Body Assessment

The table summarises ordinary procedures for products within each act’s scope, subject to the CRA open-source exception below. It is not an exhaustive list of sector-specific exemptions, special procedures or transitional arrangements. Eligibility under one law does not remove obligations under another. Verify the specific product classification against the current legislation and annexes.

Product / legislation	Assessment route	Mandatory notified body?
Non-radio electrical equipment within LVD, EMC and/or RoHS scope	Internal production control is available under these acts	No under these routes; check other applicable laws
RED: relevant harmonised standards fully applied for Article 3(2) and applicable Article 3(3) requirements, with relevant OJ restrictions respected	Module A is available	No under this route
RED: relevant standards for those requirements absent, not applied or only partly applied	B+C or H	Yes for the affected requirements
MDR: ordinary Class I devices, excluding sterile, measuring and reusable surgical instruments; not custom-made or investigational devices	Manufacturer’s declaration under Article 52(7)	No under this procedure
MDR: Class Is, Im or Ir	Article 52(7) procedure with limited notified-body involvement	Yes for the specified sterility, metrology or reuse aspects
Machinery Directive 2006/42/EC: machinery outside Annex IV	Internal checks under Annex VIII	No under this procedure
Machinery Directive 2006/42/EC: Annex IV machinery	Internal checks are an option only if the applicable harmonised standards cover all relevant essential health and safety requirements and are followed	Conditional; otherwise EC type-examination plus internal checks, or full quality assurance
CRA: products outside the important/critical categories	Internal control based on Module A is available	No under this route; conformity assessment obligations apply from 11 December 2027
CRA: important Class I products	Internal control only where Article 32(2)’s standards/specifications/certification conditions are met; otherwise B+C or H	Conditional; applies from 11 December 2027
CRA: important Class II products	B+C or H; qualifying EU cybersecurity certification may provide an alternative under the Act	Third-party route; Module A alone is insufficient; applies from 11 December 2027

CRA open-source exception: Article 32(5) allows manufacturers of qualifying free and open-source software in Annex III’s important categories to use Article 32(1) procedures, including internal control, if the technical documentation is made public when the product is placed on the market. This exception is separate from the Act’s exclusion for free and open-source software supplied outside a commercial activity.

For CRA critical products, Article 8 provides a certification framework and, absent the relevant delegated acts, refers to Article 32(3). They should not be treated as ordinary self-assessment products. [Sources: MDR, Article 52; Machinery Directive, Article 12; CRA, Articles 2(3), 8 and 32.]

Current Rules and Upcoming Changes

Machinery: Directive 2006/42/EC remains the relevant regime for machinery placed on the market before 20 January 2027. The main requirements of Regulation (EU) 2023/1230 apply from that date; its higher-risk categories are in Annex I, not the Directive’s Annex IV.
CRA: the conformity assessment and CE obligations generally apply from 11 December 2027. Article 14 reporting obligations already apply from 11 September 2026; these are a separate obligation.
RED cybersecurity: Delegated Regulation (EU) 2022/30 has applied since 1 August 2025 to the equipment it covers. For self-assessment, check the applicable Article 3(3) requirements and the restrictions accompanying the EN 18031 references in the Official Journal. A generic cybersecurity test report does not establish eligibility for Module A. The repeal of that delegated regulation takes effect on 11 December 2027, alongside the CRA’s main requirements.

Market Surveillance and Manufacturer Responsibility

Self-assessment requires evidence and continuing compliance. Authorities can request documentation, carry out product checks and require corrective action, withdrawal or recall where the legal conditions are met. Applicable legislation also provides for penalties. A notified-body certificate or laboratory report does not transfer the manufacturer’s responsibility for conformity. [Sources: Blue Guide, sections 3.1 and 7; RED, Articles 10 and 40–43.]

Practical Pre-Market Checklist

Use this checklist to organise the assessment of a specific product. For each item, record the applicable rule, your conclusion and the supporting evidence; the exact obligations depend on the product legislation.

Define the product. Record its intended use, hardware and software versions, accessories and target markets. Distinguish the finished product from separately supplied components.
Map the applicable legislation. Check each act’s scope and exclusions, including any relevant GPSR obligations. Separate current requirements from future application dates.
Confirm the assessment route. Verify the product category and conditions under every applicable act. Record why internal control is permitted or where a notified body is needed.
Check the standards references. Record the exact versions, OJ references, covered requirements and restrictions. Document any partial application or alternative technical solutions.
Plan the technical evidence. Identify the required tests, calculations, risk assessments and relevant supplier evidence. Distinguish laboratory testing from notified-body assessment.
Complete the technical documentation. Check the contents required by each act and ensure the evidence relates to the product version being placed on the market.
Check series-production controls. Document how production remains compliant and how relevant design, software, component or manufacturing changes will be reassessed.
Prepare the declaration. Use the applicable structure, legal references, signatory details and required translations. Include notified-body details where applicable and meet RED’s accompanying-declaration requirement if relevant.
Check marking and accompanying information. Verify CE placement and other required product information, instructions and warnings. For RED equipment, check CE on the packaging as well.
Set retention and update responsibilities. Record the applicable retention period, who maintains the evidence and which product or legislative changes will trigger a new review.

Basis: the assessment steps above; Blue Guide, sections 3.1 and 4.3–4.5 and the applicable sector legislation.

Declaration of Conformity — The manufacturer’s formal declaration, also used in procedures involving notified bodies.
CE Marking — Marking required by the applicable EU harmonisation legislation.
Conformity Assessment — The process of demonstrating that applicable requirements are met.
Technical File — Evidence supporting product conformity.
Notified Body — A designated body for the conformity assessment tasks within its notification.
Module A — Internal production control, where the applicable legislation permits it.

Inovasense supports hardware manufacturers with applicable-legislation mapping, assessment-route selection, technical documentation and declaration preparation. Laboratory testing is arranged where needed. See our EU Compliance services.