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Regulatory Compliance Glossary

Your reference for compliance, identity verification, and regulatory terminology. Clear definitions of key terms.

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Brexit Regulatory Divergence

Brexit regulatory divergence refers to the growing differences between EU and UK rules following the UK’s withdrawal from the EU. These differences can affect product marking, registration, representation requirements, and market access obligations for businesses operating in both regions.

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Supply Chain Due Diligence

Supply chain due diligence involves processes used to identify, assess, and manage compliance risks within a product’s supply chain. This may include verifying supplier practices, reviewing documentation, and monitoring regulatory obligations to reduce legal and reputational risks.

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Product Registration

Product registration refers to submitting required product information to official regulatory systems before sale, where mandated by law. Requirements vary by sector and may involve databases such as EUDAMED, CPNP, or national regulatory portals.

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Regulatory Compliance

Regulatory compliance means meeting all applicable legal requirements before placing a product or service on the market and maintaining those obligations afterward. This includes documentation, testing, labelling, reporting, and ongoing monitoring as required by sector-specific laws.

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Third-Party Testing

Third-party testing refers to independent product testing carried out by a laboratory or certification body separate from the manufacturer. It is often required for higher-risk products and supports evidence of safety, performance, or regulatory compliance.

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Accredited Laboratory

An Accredited Laboratory is a testing facility formally recognised as competent to perform specific tests according to defined international or European standards. Accreditation is typically granted by a national accreditation body and provides confidence in the reliability and validity of test results.

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Distributor Obligations

Distributor obligations apply to businesses that make products available within the supply chain without being the manufacturer or importer. Distributors must exercise due care, verify required markings and documentation are present, and cooperate with authorities if safety concerns arise.

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Importer Obligations

Importer obligations refer to the legal duties of businesses placing products from outside the EU or UK onto the respective market. Importers must verify that products comply with applicable legislation, ensure documentation is available, and provide their contact details on the product where required. They share responsibility for compliance alongside manufacturers.

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Competent Authority

A Competent Authority is the national regulator responsible for enforcing specific legislation within a country. Depending on the sector, this may include product safety authorities, data protection regulators, or medical device agencies. Competent Authorities oversee compliance, conduct inspections, and take enforcement action where necessary.

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European Economic Area (EEA)

The European Economic Area (EEA) includes all EU Member States plus Iceland, Liechtenstein, and Norway. It extends many EU internal market rules — including product safety and CE marking requirements — to these additional countries. Products that comply with relevant EU legislation can generally circulate freely within the EEA.

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