Get ready for the new European Medical Device Regulation May 15, 2020 UPDATE: It is confirmed that, due to the Covid-19 pandemic, the MDR is delayed. Please read Sparta’s update about what that means for you.The current Medical Device Directive (MDD) that has been in effect for nearly 25 years is 60 pages long. Regulation (EU) 2017/745, the new MDR, is 174 pages long and adds new requirements, which means that compliance in the EU is going to take a lot more expertise. But by understanding the new MDR, medical device manufacturers can get ahead of the curve and keep headaches—and compliance costs—to a minimum.What Is the New MDR?The good news is that the MDR is a regulation, which means that it has the force of law all over the single market. Because the MDD was a directive, the EU’s national governments passed sometimes conflicting laws based on the MDD that manufacturers have had to navigate.The new regulation, delayed to 2021, mainly updates and expands the MDD. Provisions that are mostly updates include new rules for registration that call for much more information about each device and that now require importers to register.Another such provision will make Notified Bodies play a much stricter and more tightly regulated enforcement role, including by performing more vigorous (and unannounced) audits and inspections. Existing Notified Bodies must all be reaccredited, and many are not expected to make the cut. In addition, the requirements and capabilities of the European Database on Medical Devices (EUDAMED) will be significantly expanded, although the updated EUDAMED won’t go into effect until 2022.What Are the New Components of the MDR?While much is familiar, several components of the MDR are wholly new. To begin with, the new regulation has been expanded to cover devices without a medical purpose, like colored contact lenses. More seriously, medical device manufacturers based outside of the EU will be required to designate individuals as Authorized Representatives who will bear personal legal liability for the manufacturers’ compliance. These individuals will be personally responsible for providing technical documentation and incident reports to Competent Authorities under the law. In a further expansion of accountability, all manufacturers will now need liability insurance to be prepared to compensate patients, if needed.Another new component of the MDR is the creation of a system for Unique Device Identifiers (UDIs) like that in use in the United States. Each device will need an UDI to aid in tracking and to combat falsification. The UDI will be entered into a public database that will expose a fair amount of information, and it will be affixed to the device itself (not just the packaging).It’s a Whole New Ballgame Post-MarketOne of the biggest changes under the new MDR is to the Post-Market Surveillance regime. Under the old rules, there was a great deal of scrutiny prior to approval and then fairly relaxed surveillance and vigilance requirements after approval. That’s all changed. The MDR mandates a continuous “life-cycle” approach to scrutiny of each device and imposes much greater burdens on manufacturers for ongoing performance and safety monitoring and reporting. More rigorous quality control and ongoing clinical assessments will increase post-approval costs, and not just for high-risk devices (although those will require even more resources to keep compliant).Increased documentation alone will take added time and resources. Summaries of Safety and Clinical Performance (SSCPs) and Periodic Safety Update Reports (PSURs) will need to be produced for every device and posted to the EUDAMED database. Expect to see quality compliance costs rise when the new rules kick in.Part of the new MDR has already taken effect: the revised Manufacturer Incident Report (MIR) has been required since January 1, 2020. The new MIR mandates standard coding and terminology recommended by the International Medical Device Regulators Forum. For that and other reasons, the MIR should help with vigilance reporting—if you can get up to speed rapidly.One tool to handle the new MIR requirements is to use an automated quality management system (QMS). The TrackWise Digital Cloud QMS from Sparta Systems already supports EU MDR 2020 requirements, and it incorporates Manufacturing Incident Report functionality. With TrackWise, you can manage core quality and compliance processes in a streamlined, automated system that prevents the errors that come with manual compliance processes. Starting in May 2020, the EU MDR will impose a significant new burden on device manufacturers. Managing quality, complaints, and documents with TrackWise is one way to keep that burden from drowning you in paperwork. Share via: Twitter LinkedIn Facebook Email
EVENT 7th Annual European Medical Device & Diagnostic Quality Assurance and Regulatory Affairs Conference Unlock tomorrow's standards today: Innovate, collaborate, and lead at the Quality Assurance and Regulatory Affairs Conference! The 7th Annual European Medical Device and Diagnostic Supplier Quality Management Conference aims to bring together the industry’s top-performing Supplier Quality Management (SQM) & QA QC professionals under one roof. Distinguished speakers will discuss cutting-edge strategies and procedures for meeting regulatory SQM & QMS requirements, implementing risk-based approaches, minimizing the risk of quality failures, and linking QA QC processes throughout the product life cycle. This two-day in-person conference will provide attendees with live content and highly interactive sessions supported by real-life business examples, case studies, Q&A sessions, panel debates, and interactive workshops. You’ll be able to network with your peers, including leading technology innovators and service providers, while exchanging ideas with the experts in a collaborative setting. We are Bronze Sponsors of the 2024 Medical Device QA & SQM Conference in Belgium. Learn more
WEBINAR AI-Driven Innovation: Redefining Quality Management in Life Sciences Take a deep dive into the confluence of AI and life sciences, exploring how artificial intelligence is poised to revolutionize the realm of quality management in the sector. Learn more
EVENT Honeywell Life Sciences Innovation Days Honeywell invites you to join us for one of our Life Sciences Innovation Days, a series offered throughout the globe in 2024. We will present a variety of process innovations to support the digital transformation of life sciences manufacturing. Themes will include orchestrating systems and data, preventing and containing cyber incidents, quality control and management, modular automation, and the Honeywell life sciences roadmap. Discussion will address streamlining manufacturing, creating batch records, and fulfilling regulatory reporting requirements. Learn more
EVENT TUG Europe Join industry peers at one of these FREE events for TrackWise and TrackWise Digital customers, with two dates and locations to choose from. Enjoy a networking at our pre-event receptions, as we celebrate 30 years of TrackWise! Take advantage of a FREE TrackWise Digital pre-event training workshop. Learn more
EBOOK 5 Things to Know About EUDAMED EUDAMED (European database for medical devices) is a centralized database that aims to enhance the transparency and traceability of medical devices in the EU. Learn more
WEBINAR EUDAMED 2024 and Beyond: Preparing for the Future of Medical Device Oversight Watch our on-demand webinar and gain valuable insights into the transformative impact of EUDAMED on the Medical Device industry. Learn more
EVENT Building a Winning Life Science Eco-system – Leveraging the Quality Link between Platform, Processes and Patients Watch this unique webinar to discover how Life Science organizations can a combine a best-in-class platform with freedom of solution choice to improve product quality, productivity, and supply chain continuity. Learn more
CASE STUDY Empowering Innovation: Revelle Aesthetics Transforms Document Management and Training with TrackWise Digital Revelle Aesthetics selected TrackWise Digital to manage its key quality management processes—document management and training management. Learn more
BLOG The Impact of Digital QMS Solutions on the Life Sciences Industry The evolution of cloud-based quality management systems is transforming expectations and changing realities in the life sciences industry. Find out how in our latest newsletter edition. Learn more
BLOG Integrated Risk Management: Go Beyond Compliance To ensure patient safety, proactively detect signals and trends and continuously improve device quality and safety, integrating quality risk management with the quality management system (QMS) is essential. In our latest article, we consider the benefits of this integration and address the growing complexity of risk management. Learn more
BLOG Cultivate a Culture of Quality: 3 Steps to Getting Started Cultivating a quality culture is critical for any organization's long-term success, regardless of industry or size. Learn more
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BLOG The Power of Integration: A Holistic Approach to Quality and Document Management One of the key components for Life Sciences companies is to have their documents and data in order.... Learn more
BLOG It’s Time For The Life Sciences Industry To Embrace Quality 4.0 Sparta’s President and CEO, Oxana Karpenko Pickeral, explores how the Life Sciences industry can address core challenges and connect the “data dots” by embracing Quality 4.0. Learn more
WHITE PAPER How Digital Technology Accelerates Your Move to Proactive Quality Leading manufacturers are embracing digitization initiatives to stay competitive in the global economy. Are you one of them? Learn more