ABSTRACT

This article provides an overview of the new MedTech European regulatory environment and opportunities for the Medical Affairs function to evolve and bring value to the respective organizations. The European Regulations ask for an increased effort from manufacturers to generate and communicate clinical evidence on the safety and performance of their Medical devices, In vitro-diagnostics and Drug Device Combinations. In conjunction with increased quality standards they make a compelling case for Medical & Scientific Governance with a prominent role for Medical Affairs in many pre- and post-market processes. A transformation of Medical Affairs into a strategic business function makes the medical device industry an exciting place to be for Medical Affairs professionals.

INTRODUCTION

For over two decades, Medical devices and In-vitro Diagnostics have been regulated in Europe by Directives for MEDICAL DEVICES (MDD) and IN VITRO DIAGNOSTICS (IVDD)^1,2,3 that were published in 1993 and 1998 respectively. A separate Directive for Active Implantable Medical Devices (AIMD) was published in 1990 with a last revision in 2009. According to these Directives, devices are approved for the European Single Market only after having obtained CE Mark for which manufacturers need to demonstrate conformity to essential requirements relating to the device’s performance and safety for patients and users. After public consultation by the European Commission in 2008 it became clear that an update of the Directives was needed, one reason being the simple fact that new technologies such as companion diagnostic devices were not yet covered. The need for revision gained traction after incidents with breast implants, transvaginal meshes around 2009 and metal-on-metal hip prostheses a couple of years later. Eventually, the revision process that started in 2012 resulted in the Medical Device Regulation (MDR) in which MDD and AIMD were combined and the In Vitro Diagnostics Regulation (IVDR)^4,5. The new Regulations were published in 2017, with May 25, 2017 as the official date of entering into force. A transition period to full implementation of the MDR and IVDR was allowed for three and five years respectively, which means the MDR applies from May 26, 2020 and IVDR from May 26, 2022.

So far so good… and then the COVID-19 crisis struck Europe, right at the moment when the medical device industry and notified bodies are transitioning to the new Regulations. Therefore, in order to “take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the coronavirus,” the European Commission has decided to move back the date on which the new MDR would fully apply by one year, to 26 May 2021. MedTech Europe, the European trade organization of medical device manufacturers, has advocated for a similar delay for the IVDR.

Since the early days of the global COVID-19 crisis the medical industry has made a so far unseen effort in finding (bio-)pharmaceutical solutions, developing vaccines and reliable test kits. Simultaneously, in an attempt to address the relative shortage of masks and intensive care equipment such as ventilators, traditional medical device manufacturers ramped up production. Although regulators accommodate the surge of new devices by fast tracks and exemption rules, new devices are subject to meticulous assessments of performance and safety. And rightly so, since national policies to curb transmission of the virus rely on the quality of diagnostics and personal protection equipment. Especially important is the scrutiny in assessing new medical devices which are intended to be used in the management of the most vulnerable and severely ill COVID-19 patients who end up in hospitals and ICUs.