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.
PRRC: Person Responsible for Regulatory Compliance
This revised article concentrates on the role of the Person Responsible for Regulatory Compliance (PRRC). The role of QP is a familiar one for those working in the Pharma sector, but this is the first time in European Medical Devices legislation...
EUDAMED Registration: Download our slide deck
With the introduction of the new Medical Device Regulations (MDR) since May 2021, we have noticed many new processes and systems being introduced. One of these has been the registration of all Medical Device Manufacturers in a totally new system...
How Unique Device Identifiers Work
The Unique Device Identifiers system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain. The overall objective of which is to improve patient safety by means of better...
What is a Medical Device under MDR 2017/245?
We first published this article in 2020. This revised article considers the definition of a medical device and explore the types of products that may fall in under the classification of a medical device post May 2021. MDR 2017/245 covers...
Understanding the Changes of MDR in 2021
The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector. The new regulations have brought about many changes compared to the previous regulatory framework. We look...
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...
