Risk Assessment

A Risk Assessment is a systematic process used by manufacturers to identify, evaluate, and document potential hazards associated with a product before it is placed on the market. It is a core element of the conformity assessment procedure under EU product legislation.

Regulatory Context

Risk assessment is required by several EU directives and regulations, including:

• the Radio Equipment Directive (RED) 2014/53/EU

• the Low Voltage Directive (LVD) 2014/35/EU

• the General Product Safety Regulation (EU) 2023/988

It forms part of the technical documentation required to demonstrate that the product meets the essential requirements of the applicable directive(s).

Purpose and Scope

The risk assessment aims to ensure that:

• All foreseeable hazards related to the intended and reasonably foreseeable use are identified.

• Adequate mitigation measures (e.g. design controls, warnings, labeling) are applied.

• The product does not present unacceptable risks to health, safety, or the environment.

The assessment must cover electrical, mechanical, thermal, chemical, and—where applicable—radiofrequency-related risks such as electromagnetic interference (EMI), RF exposure, or spectrum misuse.

Integration in Technical Documentation

Risk assessment must be documented and included in the product’s technical file. It should contain:

• Identification of hazards (per use case and misuse scenarios)

• Evaluation of risk severity and probability

• Description of risk reduction measures

• Residual risk evaluation (if applicable)

Manufacturers must ensure that this documentation is available to authorities for at least 10 years after the product has been placed on the market.

Lifecycle Relevance

Risk assessments should be continuously reviewed and updated throughout the product lifecycle, especially in response to:

• Design changes

• Regulatory updates

• Market surveillance findings

• User feedback or incident reports

This ensures that the product remains safe and compliant beyond its initial market placement.

Relation to Standards

While no single harmonized standard governs all aspects of risk assessment, relevant guidance can be found in:

• ISO 12100 – General principles for risk assessment of machinery

• EN IEC 62368-1 – Hazard-based safety engineering for AV/ICT equipment

• Sector-specific application guides (e.g. for medical, RF, or electrical equipment)