Europe – Countdown to EU MDR and IVDR

Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.
 
MDR and IVDR, close up
Full implementation of MDR is slated for next year and IVDR for 2022, but concerns remain about manufacturers’ ability to meet the deadlines. In Implementing the MDR: Slowing down on the homestretch?Gert Bos, an expert in European regulations, writes that many manufacturers are far from ready to comply with the requirements, despite available guidance and clarity on the expectations. There are concerns about the limited number of notified bodies and also about the no-grandfathering rule, which does not permit remote initial MDR audits, even in the midst of the COVID-19 pandemic. Without a verified quality management system (QMS) in place, it is not possible to continue certification of medical devices under the MDR, Bos warns, and he urges the EU to address these shortcomings.
 
In IVDR, notified bodies, and technical documentation: The devil is in the detailSue Spencer, a medical device, IVD, and notified body expert, discusses notified bodies’ expectations for the technical file and provides some practical tips on preparing submissions. Spencer says manufacturers that have already engaged with a notified body have found the process easier than expected but warns the submission process requires meticulous, time-consuming attention to detail and applicants should set aside enough time and resources for meeting the deadline…