The Medical Devices Introductory Course 2020

Conclusions

• Conformity to the ERs/GSPRs can only be assumed when the following items are aligned with each other: • the information materials supplied by the manufacturer (the labelling, instructions for use, available promotional materials) • the clinical evaluation (the device description used for the clinical evaluation, other contents of the clinical evaluation report) • the available clinical data (such as results of clinical investigations, publications, PMS studies, etc.) • If further/ongoing actions have been identified as part of the clinical evaluation, these should be described • Statement needed on when the clinical evaluation will be updated (every X years depending on risk profile or immediately when there are clinically significant changes)

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Information on evaluators

• Declarations of interests (DOI) of the evaluators should be held by the manufacturer and cover relevant financial interests outside the current work as an evaluator • DOI should contain statements that clarify the extent of the declaration • Evaluator CVs and evidence of appropriate training also required

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