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.
The Latest Acorn Regulatory Newsletter
May 2021 Covid-19 related travel restrictions have driven many audits online. While the audit might now be conducted online, it still needs to be prepared properly and it needs to run smoothly. We look at how you can prepare and...
