The Medical Devices Introductory Course 2020

Scoping pre and post CE-marked devices

Pre Post

Device description

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• MEDDEV 2.7/1 rev. 4 lists different aspects to consider at the scoping and planning stage, depending on whether the device is CE-marked • MDCG 2020-6 provides guidance on devices previously CE-marked under the Directives • Lists sections of MEDDEV 2.7.1 rev. 4 still relevant under MDR • Specifies minimum requirements for a modified CEP for legacy devices

Design features, indications, target populations, intended purpose, claims

Equivalence

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Risk management

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Current knowledge/state of the art Data sources and types of data to be used Changes to design, materials, manufacturing processes, IFU

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Newly emerged clinical concerns

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Relevant PMS data

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The Organisation for Professionals in Regulatory Affairs

CEP example table of contents – what is missing?

Clinical Development Plan!

The Organisation for Professionals in Regulatory Affairs