Most Read Medical Device Articles of 2019

2019 has been a busy year for people involved in the medical devices sector.  The imminent arrival of MDR, on May 26th next year, is concentrating the minds of those within the industry.  It has been a busy year also for our medial devices team.  Nevertheless, they have had time to look at the big issues in the sector and write about them for the Acorn Regulatory website. 

Here are some of the most widely read articles that the wrote in the past year.

Impacted By The LRQA Decision? Here Is How We Can Help

The decisions by Lloyd’s Register Quality Assurance (the LRQA) and QS Zurich that they will both will cease to offer notified body services under the EU’s existing medical device and in vitro diagnostic directives and that they will not seek to become a notified body under the new medical device regulations has been met with some dismay by manufacturers.  You can read more about how this issue caused many issues for concerned companies, here.

The 5 Responsibilities of the Person Responsible for Regulatory Compliance (PRRC) under MDR

As part of our series of articles looking at some of the changes on the way for medical device regulation under MDR, we are looking at 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 that a person is required to be appointed by a manufacturer to take specific responsibility for regulatory compliance of devices.  Read more about it here.

Get The Acorn Regulatory Medical Device Regulations Whitepaper

The new medical device regulations (MDR) will come into force in May 2020.  In advance of the deadline, companies across the world are working to ensure that their devices will comply with the new regulations.  For many companies there is still much work to do. Also, companies are still actively seeking further information about the regulations and how they will be applied.  Download the whitepaper, here.

The Medical Device Regulations – What You Need To Know

Change is the only constant in the life sciences sector and the introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. We have been working with many companies to support them for the changeover from the MDD to MDR. During the course of our interactions with these clients there are many topics that are being raised time and again.  Read the full article here.

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About the Authors:

Orla Keane
Medical Devices Manager
An engineer by background, she has 15 years experience in medical devices. Prior to joining Acorn Regulatory, she spent over 12 years at the HPRA in various roles within the medical devices team. She was responsible for a team within post market surveillance and vigilance across various general and active implantable medical device product families. Orla also served as co-Chair of the Compliance and Enforcement working group in Brussels for many years. She has previous industry experience at an orthopaedic implant manufacturer. Orla currently assists Acorn Regulatory clients in a variety of areas including regulatory strategy, EU authorised representative support and preparation for MDR, particularly on the topic of post market surveillance. You can read medical device and related articles written by Orla Keane by clicking the link below.
Other articles by Orla Keane

Bronwyn Kelly
Senior Regulatory Affairs Advisor - Medical Devices
Bronwyn Kelly is a Senior Regulatory Affairs Advisor in our growing medical devices team. She has a wealth of experience in both device and pharmaceutical regulatory affairs and she has worked with some of the world's biggest companies in both sectors, In her current role she works with device clients on issues such as EU Authorised Representative and PRRC (Person Responsible for Regulatory Compliance) related issues. You can read medical device and related articles written by Bronwyn Kelly by clicking the link below.
Other articles by Bronwyn Kelly