Module 19: Regulation of In Vitro Diagnostic Medical Devices

28/03/2023

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Common pitfalls in technical files

‘The most common reasons for delays in Technical Documentation reviews by notified bodies are:’ • ‘Incomplete Submissions – Insufficient or missing information that is required for the conformity assessment activities.’ • ‘Lack of Cohesive Structure of Technical Documentation - The information is presented within the Technical Documentation but is unorganized and difficult to locate.’

The Organisation for Professionals in Regulatory Affairs

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Common pitfalls in technical files

‘The most common reasons for delays in Technical Documentation reviews by notified bodies are:’ • ‘Verification reports provided should be complete, i.e., not a report with subsequent amendments or revisions as the device was changed.’ • ‘There are many areas of the technical documentation that will require the duplication of information for multiple documents such as device description. Please ensure that the information is correct throughout all areas where this information is duplicated and consider the risk of potential errors/inconsistencies when updating (e.g., Basic UDI-DI, UDI DI, intended purpose, indications for use, contraindications, warnings, etc.)..’

The Organisation for Professionals in Regulatory Affairs

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