Module A (Internal Production Control) — Conformity Assessment Route
Module A, formally titled Internal Production Control, is one of the eight EU conformity assessment modules defined in Decision 768/2008/EC (the “New Legislative Framework” or NLF). It is the simplest and most widely used module — and forms the legal basis for self-declaration of conformity across the majority of CE-marked hardware products.
When a manufacturer says they are “self-declaring conformity” for CE marking, they are almost always following Module A — whether or not they use that term explicitly.
Key Facts
| Detail | Information |
|---|---|
| Formal name | Module A — Internal Production Control |
| Legal basis | Decision No 768/2008/EC (New Legislative Framework) |
| Conformity route | Manufacturer self-declaration — no Notified Body required |
| Output | EU Declaration of Conformity + CE marking |
| Applicable legislation | RED (2014/53/EU), LVD (2014/35/EU), EMC (2014/30/EU), RoHS, Machinery (non-Annex IV), GPSR, CRA (Default class) |
| Technical file | Required — must be maintained for 10 years |
| Testing | Manufacturer’s responsibility — typically via accredited test labs |
The Eight EU Conformity Assessment Modules
EU product legislation organises conformity assessment into eight standardised modules (A through H), each representing a different combination of design assessment, production assessment, and third-party involvement. Products are assigned to specific modules by their governing directive based on risk level:
| Module | Name | Third-Party? | Scope |
|---|---|---|---|
| A | Internal Production Control | ❌ None | Low-risk products; manufacturer self-declares |
| A1 | Internal Production Control + supervised testing | ❌ / Partial | Module A with mandatory accredited lab testing for specific tests |
| B | EU Type-Examination | ✅ Notified Body | Design assessment only — always paired with C, D, E, or F |
| C | Conformity to Type | ❌ None | Production conformity to the examined type (Module B required first) |
| D | Production Quality Assurance | ✅ Notified Body | QA system for production stage |
| E | Product Quality Assurance | ✅ Notified Body | QA system for testing stage |
| F | Product Verification | ✅ Notified Body | Testing of each product or statistical sample |
| G | Unit Verification | ✅ Notified Body | Each unit individually verified. Used for unique/custom products |
| H | Full Quality Assurance | ✅ Notified Body | Full QA system covering both design and production |
For most hardware products — consumer electronics, IoT devices, radio equipment, industrial sensors — Module A applies, meaning the manufacturer assesses and declares conformity independently.
What Module A Requires of the Manufacturer
Module A places the full burden of conformity assessment on the manufacturer. The three core obligations are:
1. Technical Documentation (Technical File)
The manufacturer must draw up and maintain technical documentation that enables assessment of the product’s conformity with all applicable essential requirements. The technical file must contain:
- General product description — intended use, target market, user population
- Conceptual design and manufacturing drawings — schematics, PCB layout references, mechanical drawings
- Bill of Materials (BOM) — all components, including manufacturer, part number, and relevant certifications
- Harmonised standards applied — list of published standards relied upon for presumption of conformity
- Results of design calculations — engineering analysis supporting safety claims
- Test reports — results from testing against applicable harmonised standards
- Risk assessment — identification of hazards and mitigating design measures
- A copy of the EU Declaration of Conformity
The technical file must be kept for 10 years from the date the last unit is placed on the market, and must be made available to market surveillance authorities on request within a defined timeframe (typically a few days to a few weeks depending on the directive).
2. Production Conformity Assurance
The manufacturer must take all necessary measures to ensure that the manufacturing process produces units that conform to the approved design described in the technical file.
In practice, this means:
- Production testing or sampling may be needed to verify each batch meets specifications.
- Any design change that could affect conformity must trigger a re-assessment.
- The manufacturer must have quality processes ensuring consistent production.
This is Module A’s equivalent of a production quality control system — though unlike Modules D and H, there is no requirement for a third party to audit or certify this system. The manufacturer self-manages it.
3. EU Declaration of Conformity and CE Marking
Upon completing the technical documentation and satisfying themselves of conformity, the manufacturer:
-
Draws up the EU Declaration of Conformity — a formal legal document listing:
- Manufacturer name and address
- Product identification (name, model, batch/serial if applicable)
- Statement that sole responsibility for conformity rests with the manufacturer
- Applicable directives and regulations
- Applicable harmonised standards or other technical specifications
- Date, place, and name of authorised signatory
-
Affixes the CE mark to the product — permanently and legibly, with the required minimum height (5mm) and proportional width.
-
The CE mark may also appear on the product’s packaging and in accompanying documentation.
Module A Variants Used in Practice
Several directives modify Module A with specific additions:
Module A + Harmonised Standard (Standard Route)
The most common scenario for radio equipment under RED: the manufacturer applies the applicable harmonised EN standard(s), collects test evidence from an accredited laboratory, and self-declares. The harmonised standard provides presumption of conformity — the most legally efficient path.
Module A + No Harmonised Standard (Non-Standard Route)
If no harmonised standard exists or applies, or the manufacturer chooses not to use one, conformity must be demonstrated against the essential requirements directly. Under RED, this triggers the EU-type examination route (Annex IV) involving a Notified Body — effectively taking the product out of Module A and into Module B + C.
Module A1 (Supervised Testing)
Some directives specify Module A with mandatory involvement of an accredited body for specific tests (but not a full design review). This is common in machinery safety where certain functional safety tests must be performed by accredited labs.
Module A and the CRA
The EU Cyber Resilience Act introduces Module A equivalents for cybersecurity conformity assessment:
| CRA Product Class | Conformity Assessment Route |
|---|---|
| Default (lowest risk) | Self-declaration — Module A equivalent; manufacturer self-assesses |
| Important Class I | Harmonised standard route (Module A) or third-party assessment |
| Important Class II | Mandatory third-party assessment — Module B+C or B+D equivalent |
| Critical | EU cybersecurity certification scheme |
For the majority of IoT hardware products (sensors, gateways, smart home devices) that fall into the Default class, Module A will remain the applicable CRA conformity route.
Module A and Market Surveillance
Module A does not exempt products from market surveillance. National market surveillance authorities actively:
- Sample products from the market and commission independent testing.
- Request technical files from manufacturers — typically with a 10-business-day deadline.
- Issue corrective actions, recall orders, and market withdrawal decisions for non-compliant products.
The legal consequence of an inaccurate Module A self-declaration is significant: the product loses its CE marking, may be ordered off the market, and the manufacturer faces administrative penalties and potential civil liability for any harm caused.
Related Terms
- Self-Declaration of Conformity — The process implemented through Module A.
- Declaration of Conformity — The formal output document of the Module A process.
- CE Marking — The visible result of completed Module A conformity assessment.
- Technical File — The mandatory documentary foundation of any Module A declaration.
- Notified Body — Required for higher-risk modules (B, D, E, F, G, H) but not for Module A.
- Conformity Assessment — The broader process of which Module A is one variant.
Most hardware products that Inovasense designs — IoT sensors, radio-connected embedded systems, smart industrial gateways — follow the Module A self-declaration route. We compile the complete technical file, manage accredited laboratory test coordination, and issue the EU Declaration of Conformity on behalf of our clients. Our EU Compliance services ensure that Module A documentation is complete and audit-ready from day one of market entry.