[Image courtesy of Google Satellite]
Melonie Warfel, Veeva Systems
As we enter 2019, the mid-2020 deadline for the Medical Device Regulation (MDR) is getting closer. It will change the rules for medical device manufacturers and distributors operating in Europe, replacing the current Medical Devices Directive (MDD). Under the MDR, companies will be responsible for ensuring that all their products meet general safety and performance requirements. This now includes cosmetic devices and medical device software for the first time.
Meeting requirements of the MDR
Compliance requires companies to fully understand the legislation and what it means for their businesses and then put in place the software and systems to ensure provisions are met. However, a recent survey found that less than one-third of organizations have a strong understanding of the MDR.
Given the short time until enforcement begins, medical device companies face compliance risks if they are not ready. They should, therefore, look to put appropriate measures in place to guarantee business continuity and minimize risk, as well as ensure they have all the necessary data and documentation to achieve compliance across their products.
Putting evidence at the heart of compliance
The MDR has a much greater focus on clinical evaluations than previous legislation had. This means manufacturers and distributors will need to demonstrate clinical evidence regarding the safety of every Class III device in their portfolios, no matter when it was introduced. This “no grandfathering” clause will particularly affect older devices for which manufacturers may have little, or no, clinical information available. Additionally, more products are likely to be designated as Class III, which will add to compliance workloads.
Manufacturers also need to take a whole-lifecycle approach – achieving compliance will not be a single, one-off event. Companies will have to maintain systems and documentation in permanent compliance throughout the device lifecycle. Accomplishing this requires various fields, including risk management, clinical evaluation, post-market surveillance and clinical studies, to work together closely.
A trigger for technology change
The increased requirements for clinical evidence under the MDR will have a major impact on medical device businesses. Running more trials will require larger investments as well as produce a corresponding need to ensure that data is stored and available in a way that can be used easily and transparently to demonstrate compliance.
That means companies should start by evaluating their existing systems and processes. When manufacturers do this, many are likely to find that the technology they use will struggle in the post-MDR world. This is because up until now, many medical device manufacturers have been able to operate through a combination of inflexible on-premise legacy systems and email for information sharing.
On the positive side, this means the MDR can be a catalyst that pushes companies to upgrade and improve their systems. Companies can look to update legacy systems and processes, transforming their technology landscapes by adopting newer and more efficient cloud-based solutions.
This newer technology provides the framework for more collaborative and transparent document and data management across all functions. It removes silos between departments, increasing transparency into workflows and document lifecycles. Using cloud technology enables easier communication and collaboration with external organizations, whether those are outsourcing partners (such as contract research organizations) or regulatory authorities. Employees can operate from wherever they are – whether home or investigative sites, updating the system directly in real time.
Achieving MDR compliance will be considerably simpler once companies have implemented new technology. It allows tasks to be documented through the entire product lifecycle, creating an audit trail across the lifecycle of the record. Everyone involved can receive automatic status updates via clear dashboards. Built-in metrics enable companies to generate reports for both internal and external use and capture valuable insight into performance. Paper and paper-based processes are removed, which increases efficiency and productivity and reduces administration.
Moving beyond the MDR
The MDR will come into force in 2019 and transform the compliance requirements of device manufacturers and distributors. Clinical-testing workloads will increase, putting a strain on existing processes and inflexible systems. Homegrown legacy solutions are unlikely to be able to achieve effective, efficient compliance.
Now is the time for manufacturers to look at modernizing their technology, which will benefit the overall business while ensuring MDR compliance.
Melonie Warfel is VP of medical devices & diagnostics at Veeva Systems. She has a track record of building profitable businesses across vertical industries including life sciences, healthcare, manufacturing and government.
