Services

CE marking & EU directives

Conformity assessment routes for products entering the European Union — across EMC, low voltage, machinery, medical devices, pressure equipment, radio, construction products and more.

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What we do

Four core areas under this service line.

/ 01

Conformity assessment routing

Identify the right module (B / C / D / E / F / G / H) for your product family and risk profile.

/ 02

Technical documentation review

Risk assessment, harmonised-standard mapping, instructions for use, and labelling review.

/ 03

Type examination & certification

Coordinated through accredited Notified Bodies where required by the directive.

/ 04

Declaration & CE marking

Final compilation of the EU Declaration of Conformity and marking specifications for market launch.

Standards

Standards we work with.

A selection of the directives, regulations and standards we cover under this service. Full scope shared per project.

2014/30/EU Electromagnetic Compatibility (EMC)
2014/35/EU Low Voltage Directive (LVD)
2011/65/EU Restriction of Hazardous Substances (RoHS)
2017/745 Medical Devices Regulation (MDR)
2014/68/EU Pressure Equipment Directive (PED)
2014/53/EU Radio Equipment Directive (RED)
305/2011 Construction Products Regulation (CPR)
2023/1230 Machinery Regulation
EU 2016/425 Personal Protective Equipment (PPE)
2009/48/EC Toy Safety Directive

How it works

Four steps from scope to certificate.

Scope review

We map your product to applicable EU directives and harmonised standards within 72 hours and confirm the assessment route.
Technical file

Joint preparation of risk assessment, test plans and documentation gap analysis.
Testing & assessment

Lab campaigns, type examination and Notified Body coordination where required.
Declaration & marking

EU Declaration of Conformity issued and CE marking specifications finalised.

FAQ

Frequently asked.

Do all products entering the EU need CE marking?

No. Only products covered by one or more “New Approach” directives or regulations require CE marking — for example machinery, electrical equipment, medical devices, toys and pressure equipment. We confirm whether your product is in scope as part of the initial scope review.

Can Boem act as a Notified Body?

For most directives Boem operates as a conformity-assessment partner that coordinates testing, documentation and Notified Body engagement on the manufacturer's behalf. Where a Notified Body is mandatory, we manage the relationship end-to-end so you keep a single point of contact.

How long does a typical CE marking project take?

Anywhere from four weeks for a low-risk product on a self-declaration route to six-plus months for medical devices or machinery requiring extensive testing. The scope review on day one gives you a precise timeline.

Ready to start?

Tell us your target markets and we'll come back within one business day with a clear scope and timeline.

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