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. 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. 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. [ninja_form id=1] Acorn Regulatory offers a full suite of services to medical device and IVD companies. Our expert team assists companies in making the transition from the MDD to MDR. We also offer EU authorised Representative services.