Module 17 2024

Howard Dobbs

04/12/2024

Advice

• Read MDR Articles 10 and 16, the MDCG Guidance documents, the UK SI and the MHRA Guidance document on virtual manufacturing • Contact your NB or UK AB and find out how they intend to implement the Article 16 requirements • Find out if they intend to audit your OEM or your OEM’s suppliers – hopefully not! • Find out if the technical documentation must be “fully integrated” and work out what this means in practice • Consider remaining an importer or a distributor – the conformity assessment process is much easier!

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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Any questions?

howard.dobbs@talk21.com

Dilbert by Scott Adams

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

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