Adverse incidents of medical devices

Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 The new European legislation places numerous new obligations on manufacturers of medical devices marketed in Europe. The current requirements for reporting adverse incidents of medical devices in Europe are detailed in the Medical Devices Directive (MDD) [1], Active Implantable Medical Devices Directive (AIMD) [2] and In-Vitro Diagnostic Devices Directive (IVDD) [3]. The current procedures are described in Guidelines on a medical devices vigilance system [4]. The manufacturer is

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Meeting reporting obligations for medical devices

Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare. Manufacturers

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