Vigilance Reporting Under the MDR: Insider’s Guide

By |2023-01-16T20:21:46+00:00January 17th, 2023|

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market surveillance and vigilance system requirements for medical device manufacturers compared to previous regulations.   The regulations are clear that medical device manufacturers and authorized representatives (AR) must take action to notify competent authorities [...]

Vigilance: IVDR – A Review of Vigilance Regulations for In Vitro Diagnostic Devices

By |2022-12-15T13:11:18+00:00December 6th, 2022|

The In Vitro Diagnostic Regulation (IVDR; 2017/746) started its staggered implementation in May 2022. Compared to the In Vitro Diagnostic Directive (IVDD; 98/79/EC), post-market surveillance and vigilance have been given their due in the IVDR; they are now clearly distinguished and treated as separate entities.   Reporting requirements in the previous Directive were not considered [...]

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