Contributed Commentary by David Novotny, Angela Brown and Nicole Cowan
September 24, 2019 | In less than 12 months, the world’s second-largest market for medical technologies will be overhauled with the implementation of the European Union’s new Medical Device Regulation (MDR), and shortly thereafter, the In Vitro Diagnostic Regulation (IVDR).
Over the past decade, faulty devices were linked to 1.7 million injuries and nearly 83,000 deaths globally. As a result, the new MDR and IVDR seek to increase medical device safety and effectiveness in the EU market, while addressing weaknesses revealed in the implementation of Medical Device Directives (MDD) by several medical device manufacturers. With the impending deadline of 2020 for MDR, over 500,000 medical devices currently on the EU market will have to be recertified to meet the new requirements, requiring stronger clinical evidence than previous directives. Alongside this regulatory recertification requirement, diagnostics alone are projected to drive a 4-fold increase in required certifications.
With no indication by the European Commission of extensions, this transition to MDR and IVDR is likely to cause hundreds, if not thousands, of products to leave the EU market, as manufacturers decide to drop older or lower volume products. Already, as a result of medical devices previously self-certifiable now requiring NB oversight, one surgical instrument maker in Germany plans to take around five highly innovative surgical products off the market, and will discontinue several hundred minimally invasive devices. Additionally, the company plans to stop new development in this area of surgical products.
As medical device manufacturers fail to bring new, or keep existing, products on the market at the hands of these regulations, the supply of transformative devices and diagnostic technologies to both hospitals and patients in need will likely be slowed or halted. Here we describe the challenges that medical device manufacturers will face as these new regulations are introduced, and how these challenges will ultimately affect the patients that need these devices.
Notified Body Backlogs
One of the greatest challenges that will affect the supply chain of medical devices under MDR and IVDR is a shortage of notified bodies (NBs), organizations designated by an EU country to assess the conformity of certain products before being placed on the market. So far, only 2 of 58 existing notified bodies have been designated to operate under the European Union’s MDR and zero for IVDR, causing a regulatory bottleneck. With one NB located in the United Kingdom, BSI-UK, its status is uncertain in the face of Brexit; although, they have established an office in the Netherlands where Dutch authorities indicate transitioning designation out of the UK should be seamless.
Furthermore, while about 80% of NBs operating under prior EU medical device directives had applied for MDR by December 2018, the certification process is complex and only a handful are expected to be designated this year. To complicate the issue further, even if all NBs are designated, increased clinical evidence requirements, along with the need to review existing devices, will greatly increase their workload.
The capacity to certify all of the approximately half million or more medical devices currently on the EU market is unrealistic. The resulting backlogs will delay new applications and could even force some existing products off the market. Moreover, these backlogs are predicted to continue through 2027, meaning the delay of new applications may persist over an extended period of time. In fact, there are already numerous NBs refusing to accept new applications.
Because NBs are charged with certifying the safety of devices ranging from bandages to pacemakers, product supply to patients and hospitals could be significantly compromised. In the case of devices such as pacemakers, a lack of supply to hospitals and patients could mean the difference between life and death to a patient.
Seeking Approval Outside of the EU
Historically, gaining a CE mark in the EU has been easier than obtaining FDA approval, but now this is changing with the lengthening timelines and increased data requirements under MDR/IVDR. Moreover, the expanded nature of the new EU process—involving the extra step of running clinical investigations through a NB compared with working directly with the FDA—could easily push the cost and time required for European certification beyond those of the US.
As a result, some start-ups are now looking to launch their products in other markets first, such as the United States or China. By shifting their business strategy to launch products in other markets, in addition to pulling existing products off the EU market, they will be further denying European patients access to innovations that could save or improve their lives. Many companies have already begun this alternative route, with some companies planning to file for US approval this autumn.
Finding a Path Forward
The new EU MDR and IVDR will go into effect in 2020 and 2022, respectively. Although these new regulations are vital to prevent problems that could severely affect patient safety, the challenges they present to device and IVD manufacturers point to a potentially profound impact on patients who may lose access to innovative products, groundbreaking diagnostic assays, and technologies. As device and IVD manufacturers experience delays due to increased requirements for clearance, the ultimate impact is prolonged delivery of improved patient treatments and overall quality of life.
David T. Novotny is the General Manager & Global Head of ICON’s Medical Device and Diagnostic Research Services business unit. David has over 18 years’ experience within the medical device, diagnostic, biotech and clinical industries. He has held leadership roles in Sponsor and CROs companies as well as in-clinic appointments. David is also an industry consultant and author to the life-science industry for the past 10 years across the product development lifecycle and clinical research field. His working experience includes strategic business development, quality systems, technology integration, business optimization, clinical operations including program management and market access. His global expertise in operations and market intelligence enables him to support clients in key markets like North America, EMEA and Asia. He can be reached at David.Novotny@iconplc.com.
Angela Brown, B.S., Director, Regulatory Affairs, Medical Device and Diagnostics Research, has over 20 of regulatory affairs and quality assurance experience with various products in the medical device industry specializing in international regulatory affairs working with universities, start-up and blue chip companies. She is experienced in transitional regulatory activities to handle the ever-changing global regulatory environment, and has a comprehensive knowledge of the regulations for the preparation and writing required for global medical device submissions including EU Technical Documentation (Technical Files/Design Dossiers), Canadian Licensing and Submissions, TGA Technical Documentation, International Product Dossiers, and JSTED, as well as US premarket submissions. Additionally, her expertise in quality assurance provides quality management system alignment as additional geographic regions are incorporated, specifically in post market activities including complaint management, adverse event reporting and recall management. Angela has held various levels of responsibility in regulatory and quality throughout her career prior to joining ICON in 2018. She is an active member of the Regulatory Affairs Professional Society (RAPS), The Organization for Professionals in Regulatory Affairs (TOPRA), and holds a B.S. in health science from Campbell University. She can be reached at Angela.Brown@iconplc.com.
Nicole A. Cowan, MSc, Director, Project Management, IVD Operations & Strategy, Medical Device & Diagnostic Research, directs IVD operations for ICON’s Medical Device and Diagnostic Research (MDDR) business unit, providing operational functional management and team leadership. Prior to joining ICON, Nicole held MedTech senior leadership positions at a large CRO, as Director of Diagnostics, and established an In Vitro Diagnostic business unit with team development and management across EMEA, Japan, and APAC. Ms. Cowan has over 13 years direct patient care experience and over ten years' industry experience directing and managing global feasibility, pivotal, and post–market studies. Cowan obtained an MSc in Molecular Biology & Microbiology at the University of Central Florida’s College of Medicine (UCF COM), with focus in neurodegenerative disease and infectious disease. During her Academia based pre-clinical research, Nicole collaborated with UCF COM Investigators to pioneer the first clinical trials at the institution. Nicole also holds a Double Bachelor’s Degree in Chemistry and Sociology. She can be reached at Nicole.Cowan@iconplc.com.