CE Risk Assessment

A structured risk assessment is mandatory in CE technical documentation. It demonstrates you have systematically identified product hazards, evaluated risks, and applied measures to reduce them to an acceptable level.

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Product

Compliance

Manufacturer

Context

Review

Tell us about your product

Basic details that appear across all generated documents.

Product name *

As it appears on the CE label

Model / type reference

Part number or model designation

Product category *

Used to auto-determine applicable directives

Product description *

Describe the product's function, technology, and intended use (min. 30 words · max. 3 000 words). For longer descriptions, create a file and upload it in the Supporting Documents step.

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Document sections

Product scope and intended use

Defines the product, intended use, and foreseeable misuse scenarios subject to risk assessment.

Hazard identification

Systematic identification of all relevant hazards: electrical, RF/EMF, thermal, mechanical, chemical, ergonomic.

Risk estimation

Severity × probability matrix for each hazard, with initial risk level scored and documented.

Risk evaluation

Determination of which risks require reduction against applicable standard thresholds.

Risk reduction measures

Control measures applied: inherently safe design, safeguarding, information for use — drawn from harmonised standards.

Residual risk evaluation

Re-assessment of remaining risk after each measure. Overall residual risk acceptability determination.

Risk assessment conclusion

Summary statement, applicable standards used, and overall conformity conclusion.

Directives requiring this

· RED 2014/53/EU
· LVD 2014/35/EU
· Machinery 2023/1230
· MDR 2017/745
· PPE 2016/425
· GPSR 2023/988

Quality & accuracy

Hazard categories and risk reduction measures are drawn from harmonised standards for your product category. AI provides product-specific risk narrative. Always review with a qualified engineer.

Frequently asked questions