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    Post-market Surveillance according Regulation (EU) 2017/745

    Any manufacturer of medical devices that comply with Regulation (EU) 2017/745 (EU MDR) as well as any manufacturer of so called “legacy devices” who wants to continue making their products available from 26 May 2021 and further must meet the increased requirements on post-market surveillance. This keynote will briefly and concisely present the requirements for a PMS system and their practical interpretation, including the regulatory standpoint on “sufficient clinical data” and expectations regarding trend analysis.


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