New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published

The European Commission has recently published a new reporting template for serious incidents under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) and incidents under the the Medical Devices Directive 93/42/EEC (MDD), the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and the In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD).

Please note that the new forms will become mandatory as of January 2020. Against this background, the European Commission has also provided a supplementary guidance document for MEDDEV 2.12-1, rev. 8 on vigilance.

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