Conformity Assessment Module Selection Guide For EU CE Marking

When a product falls under an EU directive or regulation, the manufacturer must follow the conformity assessment procedure set out in that law. Most procedures are assembled from modules listed in Decision No 768/2008/EC, Annex II. This conformity assessment module selection guide explains how to read those modules, match them to your product and production system, and build evidence that survives market surveillance. For the file itself, see EU CE Marking Technical File: A Practical Guide.

What EU Conformity Assessment Modules Are

Modules are standard building blocks. They describe who assesses what: the manufacturer, a notified body, or both. Decision No 768/2008/EC, Annex II sets out modules A through H, with variants A1, A2, C1, and C2. Module A is internal production control. Module B is EU-type examination. Module C is conformity to type. Module D covers quality assurance of the production process. Module E covers quality assurance of the product. Module F is product verification. Module G is unit verification. Module H is full quality assurance. Sectoral laws may add or restrict modules. The legal text for your product always wins over general guidance.

How Modules Combine

Few products use a single module in isolation. A common pairing is B plus C: a notified body examines the type, then the manufacturer controls production. B plus D, B plus E, or B plus F adds a notified body role in production or verification. Module H is a full quality management system route, often with design examination. Module G verifies one unit. Module A is self-assessment, but only where the law permits it. Check the annex of the applicable regulation or directive for the exact combinations.

How to Use This Guide

Treat module selection as a legal reading exercise, not a commercial preference. Start with the product legislation. Identify the scope, definitions, and exclusions. Then find the conformity assessment annex. It will list the available modules and any conditions, such as risk class, capacity, or production type. Next, map the module to your actual operations. If the module requires a notified body, confirm that a body is designated for that legislation and scope. The NANDO database is the official source. Finally, define the technical documentation, declaration, and marking duties. This conformity assessment module selection guide cannot replace the legal text, but it can help you ask the right questions.

Step-by-Step Module Selection

1. Identify the legal instrument. Confirm whether it is a regulation, directive, or implementing act. Check the current consolidated version.
2. Classify the product. Risk class, intended use, and technology often determine the available modules.
3. Read the conformity assessment annex. Note whether the module is mandatory, optional, or conditional.
4. Match the module to production. Module A suits stable, low-risk production. Module D or H suits complex manufacturing with a mature quality system.
5. Check notified body scope. A body designated for one regulation may not be designated for another. Verify scope in NANDO.
6. Build the technical documentation. Include drawings, risk assessments, test reports, and quality records. For quality system documentation, see ISO 9001 documentation requirements guide.
7. Draft the EU declaration of conformity. Reference the legislation, module, and standards used.
8. Affix CE marking. Do this only after all obligations are met.

Module-by-Module Practical Comparison

Module	Notified body	Typical evidence	Best fit
A	No	Technical documentation, internal checks	Low-risk products where law allows
B	Yes	Type examination certificate, test reports	Designs needing independent type approval
C	No after B	Production checks, declaration	Follow-up to B
D	Yes	Production QMS audit, surveillance	Process-driven manufacturing
E	Yes	Product QMS audit, surveillance	Product quality systems
F	Yes	Product verification, certificates	Batch or individual verification
G	Yes	Unit verification, test reports	One-off or small-batch products
H	Yes	Full QMS audit, design examination	Complex products with design control

Some modules have variants A1, A2, C1, and C2 that add supervised testing or checks. The applicable law decides which variants are available.

Evidence, Notified Bodies, and Documentation

A notified body is an organisation designated by an EU member state and listed in NANDO. It assesses conformity under a specific legal instrument. Its scope matters. A certificate outside that scope has no legal value. The manufacturer remains responsible for compliance, even when a notified body is involved. Technical documentation must show that the chosen module was applied correctly. Keep design records, risk assessments, test reports, supplier evidence, and production controls. If the notified body processes personal data, handle it under GDPR. A data processing agreement may be needed; see GDPR Data Processing Agreement Clauses: A Practical Guide. Where packaging or transport testing is relevant, standards such as ASTM D4169 can support evidence. For material specifications, ASTM A36 may appear in technical files for structural steel products. Quality systems often align with ISO 9001, ISO 14001, and ISO 45001, but these certificates do not automatically satisfy a module. The module's own requirements govern.

Common Pitfalls and Audit Readiness

The most common mistake is choosing a module before reading the legal annex. Another is assuming an ISO 9001 certificate equals Module H. It does not. Module H has specific design, production, and surveillance obligations. A third pitfall is using a notified body outside its designated scope. A fourth is treating the technical file as a one-time document. Update it when the design, standards, or legal text changes. Market surveillance authorities can request the file, the declaration, and evidence of module application. Keep version control and traceability. If you outsource design or production, define responsibilities in contracts and ensure the module still fits. For a practical file structure, review the EU CE Marking Technical File: A Practical Guide. For quality documentation, the ISO 9001 documentation requirements guide is a useful companion. A disciplined conformity assessment module selection guide should be part of your compliance procedure, not a one-off exercise.