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AMS Consultants
The most visible manifestation of your commitment to the market

Product Labelling Compliance

While a product label may seem like a final administrative detail, it is actually the most visible manifestation of your commitment to the market. Accurate labelling is critical to brand integrity and user safety.

Applicable regulation
  • 2006/42/ECMachinery Directive Article 18Machinery labelling requirements
  • (EU) 2017/745MDR Annex I Chapter IIIMedical device labelling and UDI
  • (EU) 2016/425PPE RegulationMarkings on PPE
What is it?

Labelling Compliance, explained.

While a product label may seem like a final administrative detail, it is actually the most visible manifestation of your commitment to the market. Accurate labelling is critical to brand integrity and user safety. Too often, European manufacturers are caught out by the highly specific warning requirements of North America, resulting in costly delays. We understand that global distribution requires a unified labelling strategy that anticipates these international nuances. To secure your market entry, our engineers verify CE and UKCA marks, FDA UDI requirements, FCC identifiers, CPSC tracking labels, and state-specific warnings like California Proposition 65. We also harmonise warning pictograms between ISO 3864 and ANSI Z535.4, ensuring absolute technical correctness across borders. We provide clear and honest advice to help you navigate these complex global marking requirements. By taking total ownership of the regulatory details, we strive for excellence to ensure your labels pass border customs and market surveillance the first time, safeguarding your reputation and accelerating your global launch.

The process

How we deliver this service

A structured sequence runs behind every project so nothing is missed and the deadline stays in sight from day one.

01

Technical Correctness

Global distribution requires a unified labelling strategy. We verify CE and UKCA marks, FDA UDI requirements, FCC identifiers, CPSC tracking labels, and state-specific warnings like California Proposition 65. We also harmonise warning pictograms between ISO 3864 and ANSI Z535.4.

02

AMS Values

Accurate labelling is critical to brand integrity and user safety. We provide clear and honest advice to help you navigate complex global marking requirements, striving for excellence to ensure your labels pass border customs and market surveillance the first time.

Applicable regulation

The directives and standards we work with

Each recommendation ties back to a specific directive, annex, or harmonised standard.

RegulationNumberScope
Machinery Directive Article 182006/42/ECMachinery labelling requirements
MDR Annex I Chapter III(EU) 2017/745Medical device labelling and UDI
PPE Regulation(EU) 2016/425Markings on PPE
Low Voltage Directive Annex III2014/35/EUMarkings on electrical equipment
Next step

Get a realistic timeline for your labelling compliance project

In this 20-minute call, you will receive a list of applicable directives, likely testing needs, and clear next steps.