With the Medical Device Regulation (MDR) published in 2017 many new requirements were introduced that relate to the systematic collection, evaluation, reporting of clinical data and the continuous demonstration of clinical evidence for safety, performance, and an acceptable benefit/risk ratio of a device. Thus, the MDR enhances the expectation on a compliant systematic approach to collect and evaluate clinical data throughout the device lifecycle in pre- and post-market phases. Included are expectations for a systematic and active post market surveillance (PMS) and post market clinical follow up (PMCF) System. Several MDCG documents provide additional information on the interpretation and implementation of the obligations to perform clinical evaluations for innovative, equivalent, and legacy devices to ensure clinical evidence for clinical claims on safety and performance. Specifics how to plan, conduct, and document clinical investigations, PMCF studies and manage the reporting to Notified Bodies (NB) and Competent Authorities (CA) are aspects that contribute to a high level of transparency and scrutiny. The role of the European Database for Medical Devices (EUDAMED) or alternative solutions need to be understood to ensure the reporting obligations and communication with EU Commission, EU Pannels, CA, NB and Public.  All provision defined in MDR and related regulatory framework need to be mirrored in the manufacturers Quality Management System. Auditing all relevant clinical aspects of the MDR are an expected integral part of the internal audit program of the Manufacturer.

Hotel recommendation:
Arthotel ANA Goggl, Hubert-von-Herkomer-Straße 19, 86899 Landsberg am Lech, Phone: +49 8191 3240