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...
MDR: An Essential Guide for 2021
We published our first essential guide to MDR in 2020. Since then, the new MDR regulation has been introduced. This updated essential guide for 2021 provides a fresh outlook on the challenges surrounding MDR. Acorn Regulatory has been at the...
Conformity Assessment Routes Under MDR 2017/745
As part of our ongoing review at the changes introduced with MDR, in this article we focus on Conformity Assessment routes. We provide a revised examination of the changes under MDR and the assessment routes for different device classifications.
Post Market Surveillance under MDR
Regulation (EU) 2017/745 on medical devices (MDR) has established specific requirements which focus on how manufacturers should establish and maintain a post market surveillance and vigilance system. This article examines how this will be implemented and sustained.