Conformity Assessment
Conformity Assessment refers to the process by which a manufacturer demonstrates that a product meets all applicable regulatory requirements before it is placed on the market. It is a mandatory step under EU product legislation and typically includes technical evaluation, documentation, and—in some cases—third-party involvement.
Legal Framework
Conformity assessment procedures are defined in:
The New Legislative Framework (NLF) of the EU
Sector-specific directives such as the Radio Equipment Directive (RED), EMC Directive, and Low Voltage Directive (LVD)
The procedures vary depending on the product category, risk level, and whether harmonized standards are applied.
Key Elements
Depending on the applicable conformity route, the process may include:
Internal production control (self-declaration)
Testing and technical documentation (e.g. test reports, circuit diagrams)
Involvement of a Notified Body (e.g. for products without harmonized standards)
Issuance of an EU Declaration of Conformity (DoC)
Affixing of the CE marking
The conformity assessment must be completed before the product is placed on the market.
Routes of Conformity Assessment
| Procedure | Details |
|---|---|
| Module A |
Description: Internal production control (self-assessment) Common Use: Low-risk products |
| Module B+C |
Description: EU-type examination + production conformity Common Use: Medium-complexity devices |
| Module H |
Description: Full quality assurance with Notified Body Common Use: High-risk or complex products |
| Procedure | Description | Common Use |
|---|---|---|
| Module A | Internal production control (self-assessment) | Low-risk products |
| Module B+C | EU-type examination + production conformity | Medium-complexity devices |
| Module H | Full quality assurance with Notified Body | High-risk or complex products |
The applicable module depends on the directive and product category.
Manufacturer Responsibility
The manufacturer is always responsible for ensuring conformity, even when delegating testing to a third party or involving a Notified Body. The Declaration of Conformity (DoC) remains the legal proof of compliance.