EU MDR: May 2020 Is Right Around the Corner
In May 2017, the European Union (EU) published the new Medical Device Regulation (MDR), marking the start of a three-year transition period for manufacturers selling medical devices in Europe. With the enforcement deadline of 26 May 2020 now in place, time is ticking for manufacturers and distributors of medical devices in Europe to ensure data and documentation meet the requirements. However, many companies are already behind in their readiness for the MDR. In a recent survey1 of 4,200 representatives from across the global medical device industry, over half (55%) claimed only a basic understanding of the new regulation.
Here, we look at the impact of the new regulation on the medical device and diagnostics market – and consider technologies that help compliance.
What is the MDR?
The MDR, which replaces the Medical Devices Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD), is intended to improve product quality, safety, reliability, and performance, by placing greater emphasis on clinical evaluations and data. It requires better transparency and traceability of devices through the supply chain and throughout the device lifecycle. And it calls for clinical evidence on all devices no matter how long they have been on the market.
Historically there has been limited oversight across the medical device industry. Increased incidents have prompted regulatory authorities to implement regulatory and compliance reforms. Although the MDR’s predecessors, the MDD and AIMDD, intended to harmonize standards, the directives had some inherent weaknesses, and changes in technology and medical science demanded additional legislation. Problems with varying interpretations of the existing rules, as well as certain incidents – such as a scandal involving defective breast implants, and safety issues with metal-on-metal hip replacements – highlighted weaknesses of the existing legal system and damaged the confidence of patients, consumers, and healthcare professionals in the safety of medical devices.
How will it impact the industry?
One of the main impacts is the “no grandfathering” clause: the new regulation requires clinical evidence on all devices. However, for products that have been available for a long time, there may be little or no clinical information available. Becoming compliant will require time, money, and resources. It will take time to assess product portfolios and identify gaps. Companies will have to look at the cost-benefit ratio and determine if high costs of collecting clinical data for legacy products is worthwhile.
“By 2020, the device industry must show clinical evidence for the effectiveness and safety of both new and existing products – this means new clinical trials,” says Andrew Tummon, director of global clinical affairs at medical technology company Integra LifeSciences Corporation. “The EU previously required a clinical evaluation report and literature review for many products. These reports involve the assessment and analysis of clinical data pertaining to the medical device to verify its clinical safety and performance.” Tummon adds that companies are faced with hard decisions on determining which existing products are worth investing tremendous resources to conduct clinical studies that meet new EU requirements.
The increasing number of clinical studies will not only impact costs, but also processes, outsourcing strategy, and even organizational design. Companies need to ensure they have the right resources in place, with knowledge across clinical, quality, and regulatory, and the capacity to take on the additional work. The MDR places new obligations on the manufacturer to maintain systems and documentation in permanent compliance throughout the device lifecycle, which requires close alignment between various fields, including risk management, clinical evaluation, post-market surveillance, and clinical studies. “These new regulations will require a significant change in operating processes for global medical device companies or any company that sells into Europe,” comments Tummon.
What can companies do to prepare for the MDR?
Medical device companies need to find ways to increase operational visibility internally and externally, enable transparent content and data management across all functions, and improve efficiency – especially in clinical, where the number of studies is expected to increase dramatically.
While continuing to bring new innovations to market, many medical device companies have largely relied on out-dated technology. Many maintain manual, paper-based processes, and homegrown, on-premise, legacy systems. There is also a dependency on email to share documents and information. These processes and systems do not support the broad visibility and control needed to meet new requirements, nor do they enable the kind of efficient collaboration with external partners that so many device companies rely on today.
“As medical device companies are forced to conduct more trials, advanced technology becomes critical,” notes Tummon. “It’s not sustainable to hire more and more people to manage an increased number of trials. With streamlined processes and capabilities to complete tasks in real-time, from anywhere, we can optimize staff time and clinical research associates can more easily execute their jobs. It’s the key to getting ahead of this compliance curve.”
How can Veeva solutions help companies meet MDR compliance standards?
Increased visibility and continuous collaboration between business functions will be key to maintaining the required permanent compliance with the new regulation. Veeva Vault Clinical Suite enables companies to unify clinical data management with clinical operations. It puts all data and documents on one system, to enable faster and easier collaboration. Vault eTMF, with Vault CTMS, provides sponsors and their partners with one source of truth for shared CTMS and eTMF operational data. Vault eTMF enables active TMF management for real-time inspection readiness, visibility, and control.
What are the first steps towards MDR readiness?
Although companies are still trying to fully understand all of the changes the MDR will bring they cannot afford to delay implementation. It will take significant time to assess product portfolios and evaluate whether the clinical data currently captured and managed meet the new requirements.
Here are three key steps organizations should take as they embark on the road to MDR-compliance:
- Understand EU MDR and plan ahead – invest time in understanding the EU MDR and how it will impact your business. Develop a plan to assess all your devices relative to the EU MDR guidelines.
- Conduct a portfolio review and gap assessment – there will be no grandfathering of legacy devices, so all devices need to be reviewed to ensure they are compliant with the guidelines. Overall, the amount of supporting data and documents has increased significantly. Documents such as post-market surveillance plans and reports, post-market clinical follow-up reports, periodic safety update reports, and summaries of safety and clinical performance are all required. Additionally, more emphasis is now placed on clinical evaluation requirements and the required clinical data that must be collected and maintained. In some cases, devices may need to be reclassified which will require additional data, documentation, and ultimately time and resources.
- Conduct a technology landscape assessment – now is the time to evaluate the systems you use across the organization to support clinical, quality, and regulatory. Systems should help improve compliance, mitigate risk, and provide increased visibility and transparency across the organization.
Contact us today to continue conversation about how Veeva can help you prepare for the MDR.
1Emergo Outlook Survey 2018 (February 2018)