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.

Update: You will see that some of our comprehensive MDR content that we have created refers to the May 2020 date of application.  The date of MDR application has moved to May 26th, 2021.  Articles that were written prior to the delay referenced the earlier date.  However, articles that you might read that reference the earlier date should be read taking the new date of May 2021 into consideration.  Read more here.

The LRQA has advised clients to seek an alternative notified body.  Clients of the LRQA have been issued with 90 days’ notice in recent days.

Furthermore, in recent days QS Zurich has also indicated that they will be withdrawing from the notified bodies market.  Commenting on the latest news from QS Zurich, Orla Keane, Medical Devices Manager at Acorn Regulatory said “the announcement by QS Zurich, coming very quickly after similar news from LRQA, brings sharply into focus the issues of capacity in the Notified Body network. It adds to the challenges already being experienced by manufacturers in trying to prepare for MDR and particularly those manufacturers who now need to transition to a new Notified Body within a very tight timeframe to maintain CE certification for their devices”.

The moves of both LRQA and QS Zurich to exit from the device sector, comes at a time when the capacity of notified bodies to take on new clients is under question. Find out how we can help just after this video (the video was recorded before the announcement by QS Zurich that they intend to exit the NB sector).

Identifying and engaging with a notified body in such a tight timeframe will be challenging.  Our medical devices experts can assist you in the selection of a notified body and they can engage with the notified body on your behalf.

We have been assisting a number of our clients since LRQA and QS Zurich have made their announcements.  If you would like to discuss issues relating to your device and seek our assistance in identifying a new notified body or if you have any questions about the notified bodies issue, then please call us on 00353 52 61 76 706 or complete the form below and we will get back to you.

Acorn Regulatory offers a full suite of services to medical device and IVD companies.  Our expert team assists companies making the transition from the MDD to MDR.  We also offer EU authorised Representative services.

Further Reading on MDR

A Guide to Drug Device Combination Products

We have produced a drug device guide that looks at the issue.  It also considers the issue in relation to the changes for drug device combination products in relation to the Medical Device Regulations.  You can download the guide 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 here.

Get The 1st 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. Read the first whitepaper here

2nd Acorn Regulatory MDR Whitepaper

Our second Acorn Regulatory MDR whitepaper looks at the issues of unique device identifiers, the role of Eudamed under MDR and post-market surveillance. Read the second MDR whitepaper here.

The Medical Device Regulations – MDR – What You Need To Know

The introduction of the new medical device regulations in May 2020 will bring significant changes to the way that we work with medical devices. Our medical device team has been working with many companies to support them for the changeover from the MDD to MDR. During our interactions with these clients, many topics are being raised time and again. Read more here.

About the Author:
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