Module 17 2024

Howard Dobbs

04/12/2024

MDR Article 22.1 Systems and procedure packs

You may combine devices bearing the CE mark with the following other devices in a manner which is compatible with the intended purpose of the devices and within the limits of use specified by their manufacturers: - other devices bearing the CE mark - in vitro diagnostic devices bearing the CE mark

You must “draw up a statement”.

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The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

27

MDR Article 22.2 Systems and procedure packs

The statement must state that: - the mutual compatibility of the devices has been verified - an IFU has been supplied which includes the information in the IFUs provided by the manufacturers of the devices or products which have been put together - the act of combining the devices was subject to appropriate methods of internal monitoring, verification and validation

28

The Organisation for Professionals in Regulatory Affairs

Howard Dobbs

28

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