Module 17 2024

Howard Dobbs

04/12/2024

When do the obligations of manufacturers apply to you?

Howard Dobbs, Director, Howard Dobbs Consulting Ltd

howard.dobbs@talk21.com

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The Organisation for Professionals in Regulatory Affairs

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Answer

The obligations of the manufacturer may apply to you if you: • place an already CE marked device on the market under your own name (i.e., you are an Own Brand Labeller or a Virtual Manufacturer) • change the intended purpose of a CE marked device • modify a CE marked device • supply a system or procedure pack • supply parts or components

All of the above are applicable to this course since they are post-market activities.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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