Taking a three-stage approach to ensure readiness for the European Medical Device Regulation
Melonie Warfel, vice president, medical device & diagnostics at Veeva Systems explains how companies can prepare for the new European Medical Device Regulation.
The EU’s Medical Device Regulation (MDR) comes into force in May 2020, and will transform the rules for all medical device manufacturers and distributors operating in Europe. Replacing the current Medical Devices Directive (MDD), it makes companies responsible for ensuring that all of their products comply with EU-wide safety and performance requirements. For the first time, it extends rules to cover software-as-a-medical-device and cosmetic devices (such as liposuction equipment and contact lenses).
The MDR aims to address public concerns after several high-profile safety cases involving medical devices. These have included defective breast implants and issues with metal-on-metal hip replacements. It achieves this through greater transparency and traceability of devices across their lifecycles and supply chains.
Getting Ready for 2020
With under two years until the MDR enforcement deadline, companies need to start now in order to ensure they have the data and documentation in place to achieve compliance across their entire product ranges. They have to understand the impact of the legislation and make certain that they have the systems and software in place to be MDR compliant. However, a survey earlier this year found that less than one-third of companies had strong understanding of the MDR.
Focus on Clinical Data Across the Lifecycle
The MDR calls for increased clinical evidence on all products sold within the EU. This means manufacturers and distributors will need to demonstrate clinical evidence around the safety of every Class III device in their portfolios, irrespective of when it was introduced. This "no grandfathering" clause will particularly affect older devices for which manufacturers may have little, or no, clinical information available. At the same time, more products are likely to be designated as Class III, which will add to compliance workloads.
The MDR’s lifecycle approach also means achieving compliance is not a single, one-off event. It mandates that manufacturers maintain systems and documentation in permanent compliance throughout devices’ lifecycles. Achieving this requires close alignment between various fields, including risk management, clinical evaluation, post-market surveillance, and clinical studies. Gaining a CE Mark will become more difficult under the MDR.
An Opportunity for Change
Given the transformative nature of the MDR, many existing systems and processes that businesses use will struggle to cope with compliance demands. The regulation therefore provides an opportunity for companies to future-proof their businesses by upgrading and improving their systems, moving away from home-grown, on-premise legacy technology.
With less than 20 months until the MDR enforcement deadline, we recommend manufacturers and distributors take three steps to ensure that they track clinical documentation and achieve compliance:
1 Understand What the MDR Means for Your Business
The MDR will impact all medical device businesses operating in Europe. The first step is therefore to take the time to fully understand the regulation and what it means for your company. Much of this is likely to revolve around the much larger volume of documentation required under the MDR. A significant amount of this will need to be generated from scratch, as, previously, clinical trials were not required for newly introduced products. Instead, the manufacturer simply had to provide clinical evidence that the device was using similar materials to those already on the market, or that it delivered the same level of effectiveness as a competitor’s product. Such an approach will no longer be compliant, given the MDR’s focus on real-world clinical evidence.
2 Review Your Entire Portfolio
Under the MDR, every device will have to have the necessary clinical evidence in place, no matter when it was introduced or if such evidence was required when it was launched. This means the MDR affects every product in your portfolio. You’ll therefore need to check that supporting data and 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 in place. Because the MDR will have greater emphasis on clinical evaluation requirements, real-world clinical data must be collected and maintained. Additionally, in some cases, some devices may need to be reclassified, which will require additional data, documentation and, ultimately, time and resources.
Reviewing your complete portfolio will show any gaps in the evidence required for MDR compliance. It will then be a matter of performing an informed cost-benefit analysis of those devices that don’t have the supporting clinical evidence. Do they generate sufficient revenue and profits to justify the expense of running a fresh clinical study to gather the necessary evidence?
3 Assess Your Existing Systems
The MDR’s focus on gathering and providing clinical evidence will have a major impact on how medical device businesses operate. Running a greater number of trials will require increased investment, while data will need to be stored and available in a way that can easily and transparently be used to demonstrate compliance. This will impact processes, outsourcing strategies, and organisational design. Just adding more staff will not be enough to achieve cost-effective compliance if you don’t have the right systems and technology in place to support them.
Begin by assessing your existing systems and processes. Are they able to support clinical, quality, and regulatory requirements across your organization? Do they help improve compliance, mitigate risk, and provide increased visibility and transparency across the organisation?
Transforming Technology for Competitive Advantage
In many cases, the answers to these questions will be "no". This is because many medical device manufacturers currently operate through a combination of inflexible, on-premise legacy systems and email for information sharing. The MDR therefore provides the opportunity to replace these legacy systems and processes, which will enable companies to transform their infrastructure by adopting newer and more efficient cloud-based technology.
This will deliver benefits far beyond MDR compliance. More modern systems provide a framework for more collaborative and transparent document and data management across all functions. Departments can work together more easily, increasing transparency into workflows and document lifecycles. Adopting cloud technology allows easier communication and collaboration with external organisations, whether that is outsourcing partners (such as contract research organisations) or regulatory authorities. Employees can be more flexible when they are able to work from wherever they are in the world and upload notes and reports from investigative sites in real time.
All of this makes regulatory compliance much easier to achieve. As tasks are documented throughout the product lifecycle, and there is a complete audit trail from a record’s entry to a system until it is archived. Status updates are automatic, and companies can quickly generate reports for both internal and external use, as well as capturing valuable insight into performance. By eliminating paper and paper-based processes, stakeholders can optimise their time, increase efficiency, and reduce unnecessary administration.
Successfully Preparing for the MDR
From May 2020, the Medical Device Regulation will dramatically increase compliance requirements for manufacturers, which will lead to much greater focus on testing of existing and new products. Companies therefore need to act now, by following a three-stage process – understanding the impact of the legislation, evaluating their current portfolios, and assessing their technology and processes. They can then take steps to meet the MDR, as well as ensuring they have the systems and infrastructure in place to improve overall business effectiveness.