The start of the new year highlights a long-awaited deadline, the date of application of the European Medical Device Regulation (EU MDR) – May 21, 2021. For MedTech companies that sell products in the European Union, this is not new news. The predecessor to MDR, the Medical Device Directive (MDD), has been in place since 1993 for nearly 25 years, with very little change. The first directive was actually the Active Implantable Medical Device (AIMD) Directive, which dates back 30 years to 1990. The in vitro diagnostic directive (IVDD) came along in 1998. Reviews of MDD to ensure appropriate levels of safety for patients started in 2008, resulting in the final implementation of the MDR and IVDR in May 2017. During the review of AIMD, MDD, and IVDD, guidelines related to the application of the directives were developed. These are referred to as MEDDEV guidelines. These guidelines are not legally binding but are developed through a process of intensive consultation with various parties, including competent authorities, notified bodies, Commissions services, industries, etc.). This helped companies (manufacturers) to comply with the Directives but did not solve all the interpretation complexities involved in a new regulatory framework where guidance is still limited.
The MDR and IVDR create a new regulatory environment for the development and commercialization of medical and in-vitro diagnostic devices that focus on transparency, predictability, and accountability to reduce risks to patients and improve the safety of medical devices made available on the EU market. Certain aspects of the regulations include: 1) There is no grandfathering rule. All medical devices will have to recertify and undergo independent safety and performance assessments before the product can be marketed in the EU. 2) There is a required centralized system called EUDAMED to access product information. This new database will allow access to patients, manufacturers, notified bodies, and authorities. 3) The regulations require more clinical evidence and greater transparency of information on the benefits for the patient, residual risks, and thorough assessment of the overall risk/benefit ratio.
"MedTech companies have been working for the past few years to understand the implication of the regulations to ensure products can be brought into compliance in a practical way and a beneficial manner for patients and end-users"
MedTech companies have been working for the past few years to understand the implication of the regulations to ensure products can be brought into compliance in a practical way and a beneficial manner for patients and end-users. This resulted in extensive conversations with regulators, external experts, Notified Bodies, and trade associations to ensure a common understanding of these new requirements. There are completely new activities, post-market clinical follow-up, and post-market safety updates, required for a large number of products. To satisfy these new requirements, companies have created new procedures and engaged strategic partners in lower-cost areas to create an efficient Center of Excellence to manage the new work and execute on product portfolio simplification. Companies have invested in subject matter experts and project management across all functions to remediate Tech Files and Product labeling, as examples. The end result is compliance with these regulations will materially impact the product lifecycle requirements for products and change how most
areas of a company - Medical Affairs, Quality, R&D, Regulatory Affairs, Supply Chain, Manufacturing, Commercial - operate today.
While all this preparation work has been ongoing, the pandemic put additional financial pressures on the MedTech industry and complicated the situation. Most companies had to quickly reprioritize work to support pandemic efforts. Others had to handle significant reductions in revenue due to shifts in product demands. The lack of guidance and consistency in regulatory interpretation of MDR/IVDR among the Notified Bodies compounds issues for companies trying to ensure product and business continuity for patients and customers. This was all in a year where some companies were dealing with Notified Body fallout and having to engage with a new Notified Body on audit requirements and prioritization of reviews. These pandemic pressures did result in the European Parliament voting in April 2020 to postpone the original EU MDR date by one year, though it did not extend the final transition date to MDR by May 26, 2025. For most companies, that delay does not impact all the ongoing work that needed to be executed to ensure compliance with MDR by the time product certificates under MDD expired by May 26, 2024.
In a new year with a long-awaited deadline quickly approaching, and with a pandemic, MedTech companies continue to put a significant amount of work and cost into compliance. While it is the right thing to do and the industry is committed to getting the work completed, it will remain a challenge for how these efforts will impact the lifecycle of products and new innovation. The limited guidance available for the new regulations, fewer notified bodies, and lack of common specifications and harmonized standards make it especially challenging for companies to comply with the new regulations in a timely and consistent manner. Engaging with notified bodies, trade associations, stakeholder discussions with the European Commission and other policymakers is critical for having an aligned approach for industry and maintaining the interests of patients.