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.
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...
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...
Download Our MDR Changes Slide Deck
The new medical device regulations will be introduced in May 2021. The MDR changes will see an increased set of responsibilities for manufacturers, economic operators, authorised representatives, and distributors. Our MDR regulatory affairs consultants are currently working with companies to...
The Northern Ireland Protocol & Medical Devices: Explained
How will the Northern Ireland Protocol impact companies in the medical devices sector? That is a question that we have been asked many times in recent months. Now, as the UK’s departure from the EU gets closer, we have created...
How Will The Northern Ireland Protocol Impact Medical Device Companies?
Our clients have been contacting us in recent weeks with questions relating to the Northern Ireland Protocol and medical devices. They are eager to understand the intricacies of the Northern Ireland Protocol and how it will impact their companies. We...
What Is A Unique Device Identifier?
The Unique Device Identifier system under the Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 IVDR applies new requirements on all participants of the supply chain with the final aim to improve patient safety through better traceability and transparency. Both...
