Thomas is an expert in Supply Chain and Manufacturing Optimization with more than 10 years of experience originating from Medical Device and High-Tech & Electronic Industries. He comes with a background as an Electronics engineer, complimented with a Master in Technology Management. Thomas has held positions in multinational corporations such as Nilfisk, heading the internal optimization program as well as the supply chain organization.
Ready for the EU MDR? Here are 3 things you must do before the deadline
For medical device manufacturers and distributors who wants to continue selling their products in the EU, the clock is ticking. May 26st 2020 marks the end date of the three-year transition period and is the final deadline for manufacturers and distributors of medical devices in Europe to ensure that their data and documentation meets the requirements.
However, many companies are still lagging in their readiness for the EU MDR. According to a recent survey conducted by KPMG and RAPS:
• Nearly 80% of the respondents currently lack sufficient understanding of the MDR
• The number of the potential Notified Bodies has dropped by 75%
• More than 60% of medical device companies believe quality requirements to be the most challenging for EU MDR compliance
In this article, we will look at the impact of the new regulation on the medical device and diagnostics market and consider technologies that will aid companies with compliance.
Fact sheet: What is the EU MDR?
The EU MDR is a new regulation with the intension to improve product quality, safety and reliability for medical device products sold and operated on European soil. By placing a greater emphasis on clinical evaluations and data, it will require medical device manufacturers to have better transparency and traceability of devices through the supply chain and throughout the device life cycle.
Finally, it also calls for clinical evidence on all devices no matter how long they have been on the market. That also means there will be no “grandfathering” options in the new EU MDR.
The EU MDR will have a significant impact on the European medical device industry. Becoming compliant will require money, time and resources. The increasing number of clinical studies will not only impact costs, but also processes and organizational design as companies need to ensure that they have the right resources in place, with knowledge across clinical, quality, and regulatory, and the capacity to take on the extra work.
The EU MDR also places new obligations on the manufacturer to maintain systems and documentation in permanent compliance throughout the device life cycle, which requires a close alignment between e.g., risk management, clinical evaluation, post-market surveillance as well as clinical studies.
What can companies do to prepare for the MDR?
Although medical device companies are still trying to fully understand all 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 meets the new requirements.
Here are three key steps organizations should take as they embark on the road to MDR-compliance:
- Abandon the paper-based processes
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.
- Conduct a portfolio review and gap assessment
As there will be no grandfathering of legacy devices, 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.
To recap
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 will increase dramatically.
How Minerva can help medical device 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. Minerva Medical Device PLM 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 with one source of truth for shared operational data.