Module 17 2024

Howard Dobbs

04/12/2024

Contents

• Introduction – who, what and why • The EU legislation and guidance • The UK guidance • Summary, conclusions and advice

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Who are Own Brand Labellers (OBLers)?

• OBLers are people who place an already CE marked device on the market under their own name or trademark. They are probably not the person who actually designed or manufactured the device. • OBLers are often large companies or supermarkets • OBLers are also called Private Labellers, Own Branders or Virtual Manufacturers

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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