The deadline for the new European Medical Device Regulation (EU MDR) is just around the corner. Are you ready?
By now, your organization has probably conducted a portfolio review and assessment. You might have even progressed to your Clinical Evaluation Report. But during the assessment process, you may have discovered significant data gaps. You might find yourself struggling to prove the safety of your device. What now?
The Challenges of EU MDR
The new EU MDR represents a significant regulatory change for medical device manufacturers. These updated regulations are designed to track the safety and efficacy of products. As of May 2020, manufacturers and distributors must show clinical evidence on the safety of every Class III device in their portfolio. This clinical evidence will face heavy scrutiny. If your data isn’t up to scratch, your company could be in trouble.
With the new EU MDR, your data will also need recurring updates. A single pre-approval review is no longer enough. Instead, new EU MDR promotes a lifecycle approach to medical device regulation. Companies must continue collecting and analyzing data after their device hits the market.
Any company that hopes to sell within the EU will also need a robust Post-Market Surveillance (PMS) system. This system must cover all the medical devices your company manufactures. Your PMS system must include a Post-Market Clinical Follow-up (PMCF) to help your company meet the EU MDR targets. PMCF facilitates quality, performance, and safety data collection throughout the device’s lifetime.
SaaS to the Rescue
Meeting EU MDR targets is achievable with robust, dynamic, and easy-to-use software. To achieve new data-collection goals, most companies will need to upgrade their software. These upgrades reflect the growing industry need for post-clinical device tracking. The right software system is an invaluable tool throughout this process.
When developing your data-collection strategy and searching for new software, consider the following:
- Data Collection
Under the new EU MDR, your company will collect more data than ever. You will need a robust system that can keep track of many data streams. - Data Systems
A robust collection of data is useless if there’s no system to make sense of it. You need software that categorizes data, leaving vital information at your fingertips. - Data Quality
An effective software system and data platform allows you to sift through mountains of data quickly. With an upgraded system, you can easily see which devices are most effective and which need further attention. - Data Analytics
An AI-enhanced software can make recommendations for treatment strategies and follow-up care. AI helps your organization crunch large volumes of data to identify treatment patterns. This software can even flag abnormal responses or identify the need for clinical interventions. - Data People
Clinicians, patients, researchers, manufacturers, and government organizations will need a share in your data. Therefore, developing a central database is essential. A robust database ensures that all stakeholders can access the information they need. - Data Privacy
To maintain your company’s license to operate and preserve your global reputation, you need software with a rigid security protocol. The right system has strict safeguards to protect client and patient privacy.
Where Does Real World Evidence Play a Role?
Once, medical devices were sent out into the world and then, often forgotten. Manufacturers frequently neglected to follow up with their patients. Little data was gathered about how patients tolerated their devices. Side effects and real-world patient practices often went unnoticed.
The new EU MDR aims to solve this problem. Manufacturers will now be required to gather real-world data (RWD) and real-world evidence (RWE) for all their devices. These two terms may seem confusing at first, but their relationship is easy to understand. RWD is gathered from patient surveys, clinical trials, and cohort studies. Once you have plenty of data, you can analyze it to draw conclusions about the risks and benefits of your medical device. These conclusions are considered RWE.
Tracking is an essential part of gathering RWD. Under EU MDR, each device will be tracked through the use of unique device identification (UDI). UDIs allow your company to record incident reports, institute recalls, and reduce medical errors. Your company can also receive real-time data about how your devices operate in the hands of patients.
RWD offers countless opportunities for device improvement. Gathering data from diverse patient groups allows you to learn which areas of your device need improvement. During the RWD-collection process, you may notice that a certain device isn’t working the way it should. Reconfiguring the device can spark innovation and lead to new developments in your company’s product catalog. Over time, these innovations can boost your company’s bottom line.
With UDIs, patients can also enjoy safer, more effective devices. But UDIs generate a tremendous amount of data that your company will need to track. Once again, a robust solution, such as those offered by SHYFT Analytics, a Medidata company, can be your saving grace. SHYFT helps your company convert data into clear, concise insights. With SHYFT, you can use your data to drive clinical development and achieve even greater success.
Thousands of companies are striving to meet the new EU MDR. But many have struggled to find a strategy that meets their needs. If your company is overwhelmed by increased demand for data, consider a new technology solution. The right system can streamline the data collection and distribution process. Efficient software ensures that your company thrives under the new EU MDR.
To learn more about how Medidata and SHYFT Analytics can help, visit us at https://www.medidata.com/en/shyft-analytics/.
Sources:
Medidata. The Rise of Integrated Data in Medical Devices. https://www.medidata.com/wp-content/uploads/2019/05/White-Paper-The-Rise-of-Integrated-Data-in-Medical-Device-May-19-1-1.pdf (Accessed September 9, 2019)
Deloitte. Preparing for the Future: The New European Union Medical Devices Regulation. https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-Health-Care/gx-eu-med-device-regulation.pdf (Accessed September 9, 2019)
Medical Product Outsourcing. 4 Ways to Prepare for the European Medical Device Regulation (MDR) https://www.mpo-mag.com/issues/2019-01-01/view_columns/4-ways-to-prepare-for-the-european-medical-device-regulation-mdr (Accessed September 9, 2019)
Medicines & Healthcare Products Regulatory Agency. Use of Real World Evidence under European MDR. https://www.pmda.go.jp/files/000221793.pdf (Accessed September 9, 2019)
Duke University. Opportunities and Gaps in Real-World Evidence for Medical Devices. https://healthpolicy.duke.edu/sites/default/files/atoms/files/rwe_medical_devices_meeting_summary.pdf (Accessed September 9, 2019)
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