EU Medical Device Vigilance Reporting: FAQ
In our first article surrounding EU Medical Device Vigilance Reporting, we discussed medical device vigilance reporting requirements for IVD and medical device manufacturers. This article will address some frequently asked questions questions about vigilance reporting that we receive from clients.
Responsibilities of Importers and Distributors
MDR 2017/745, which was enforced on May 26th, 2021, expands the responsibilities of importers and distributors. This article will examine the revised responsibilities of the importer and the distributor under the new regulation
EU Medical Device Vigilance Reporting
All medical device manufacturers are required to have an effective system for the review and evaluation of customer complaints. The European Commission guidance MEDDEV 2.12/1 revision 8, describes the steps involved for the notification and evaluation of Incidents, Field Safety...
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