MDD Devices

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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… Read more

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. … Read more