Has your company addressed the challenges that the new Medical Device Regulation (MDR) will bring? Here are 3 pieces of advice you can follow on your road to compliance.
Complying with the New MDR can bring benefits to your medical device. However, the new MDR calls for stricter rules, more transparency and increased availability of quality data. To address compliance, this blog post will highlight our 3 pieces of advice on how you can initiate compliance and plan ahead. The following sections explain how certain steps can be taken to move towards the direction of compliance.
1. Digitize Your Clinical Data Management
The era of digitally managing your clinical data is here and now. With the new MDR comes an increased requirement for quality clinical data (both pre-market and post-market). Medical Device Manufacturers will have to supplement their device with existing clinical data or generate additional data. To tackle this issue digitizing your clinical data management is the way to go. The benefits include speedy access at any time and from dispersed locations. Have your vital data stored safely and securely in a single location. This will enable you to provide the required data in an efficient way when requested. Dive deeper into the importance of digitizing your data collection and how optimizing generation of clinical evidence for medical devices can contribute to compliance.
2. Establish Overview by Choosing Long-Term Solutions
Above we mentioned the benefits of digitizing your clinical data management. Let’s move on to how this enables you to establish control and maintain an overview. Adhering to the new MDR would mean stricter rules on clinical investigation and an increased need for reliable clinical data. This requires increased traceability of your clinical data.
As such, you should look at the bigger picture. Try to improve the whole process but not just a part, to gain control and overview. With this in mind, solutions that prove beneficial in the long-run are the answer.
Don’t select “one-time-solutions” for data collection. Choose a long-term partner to service, host, and help manage your evidence.
Additionally, try to keep data in one place and focus on accessibility and platform solutions. Platform solutions can provide you with access to all your operations and data in one place. Through a controlled overview, you will be able to produce and access data on demand as and when requested by Notified Bodies. Accessibility is easier when data is well structured. Structured data can be easily accessed when you have a clear overview.
3. Eliminate Missing Data by Designing Better Forms
Manufacturers must meet stricter requirements as to the quality, performance and, safety of medical devices. Improve the data quality by designing better forms to minimize the chance of missing data. Subsequently, better-designed forms can increase response-rates and can lead to better Patient-adherence.
Furthermore, this has shown to decrease the time spent on data management, which results in lowered costs, and eventually a shorter time to market. Through well-designed forms, you can eliminate missing data. And, comply with the new MDR by producing quality data that is relevant to your device.
For the past couple of years, we have helped organizations in both setting up and designing forms for electronic data capture. This covers everything from multi-site trials to post-market surveillance for medical devices, to public research.
This has greatly inspired us and led us to write our own guide on the subject. Get a better understanding of How to design better eCRF’s, by downloading our white paper. We explain the 7 principles behind a good eCRF.
3 Pieces of Advice on How to Comply With the New MDR
Digitizing your clinical data management can enable you to efficiently set up your process towards compliance. Establishing an overview by choosing long-term solutions is part of the process where data is stored in one location and easily accessible. Lastly, the elimination of missing data by designing better forms results in the production of quality data. This leads to higher response rates and improved adherence. Those were our 3 pieces of advice that we hope can guide you on your road to MDR compliance.
Have you looked at the MDR requirements? If not, you can take a look at a great 30-minute video from TÜV SÜD on the matter.
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