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EU Medical Device Vigilance Reporting: FAQ

EU Medical Device Vigilance Reporting: FAQ

by elena@investinu.ie | Oct 27, 2021 | Acorn Regulatory News, Pharmacovigilance

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 about vigilance reporting that we...
Responsibilities of Importers and Distributors

Responsibilities of Importers and Distributors

by elena@investinu.ie | Oct 12, 2021 | Acorn Regulatory News, Medical Devices

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. What is an Importer under MDR 2017/745?...
EU Medical Device Vigilance Reporting

EU Medical Device Vigilance Reporting

by elena@investinu.ie | Sep 27, 2021 | Acorn Regulatory News

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 in the notification and evaluation of Incidents and...
MDR: An Essential Guide for 2021

MDR: An Essential Guide for 2021

by elena@investinu.ie | Sep 24, 2021 | Acorn Regulatory News, Medical Devices

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 forefront of the MDR...
Conformity Assessment Routes Under MDR 2017/745

Conformity Assessment Routes Under MDR 2017/745

by elena@investinu.ie | Sep 22, 2021 | Acorn Regulatory News, Medical Devices

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. Increase in...
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