Post-market Clinical Investigation:
For post-market clinical investigations, adherence to the principles outlined in the ISO14155:2020 and other regulations and guidelines is recommended, as far as they are relevant, taking into account the nature of the clinical investigation. According to this standard, post-market clinical investigations are conducted subsequent to the market approval of a medical device. Their purpose is to address specific inquiries concerning the clinical performance, effectiveness, or safety of a medical device when used in accordance with its approved labelling. In comparison to pre-market studies, post-market investigations may benefit from certain exemptions outlined in the standard, making these studies administratively simpler.
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Please note that if marketed products are being investigated for new indications, beyond those described in the approved labelling, normative guidelines for pre-market clinical investigations apply.