April 6, 2020 EU MDR

Real-World Approach in Collecting Clinical Data for MDR & IVDR

The deadline for MDR is drawing near and for IVDR too there is not much time. In such a situation, manufacturers are busy in the process of collecting all sorts of data. Among these, clinical data fills up a major position consuming a lot of time and money. The best decision at this moment would be to broaden your sphere and not to concentrate only on the CE mark. In doing so, you will get a clear perspective as to how the Real World Data might keep you well ahead of your competitors. As we move ahead we would be giving you deeper insights into the data collection process, the impact of the data and the way it eases your task.

RWD &RWE in Data Collection

Real World Data (RWD) is collected directly from the patient’s health records, wearable devices, electronic health records available in hospitals or with insurance companies, and various other sources. They can even be collected through patients own reporting about the outcomes or the changes and benefits that he has faced. Similarly, Real World Evidence (RWE) is derived from that data through research and analysis. This RWE can be considered as clinical evidence as this helps in the detection of the risks and benefits associated with the medical device. The real-life evidence would make further studies easier and at the same time, its purpose gets defined. The RWE clarifies the treatment in which the medical device is being used and how effective it is in treating the same.

Benefits in MDR & IVDR

Sponsors and regulators are gradually showing more acceptance of such Real World Data and Evidence thus making it a more obvious choice in the collection of both clinical and regulatory data. The MDR and IVDR regulations are becoming very strict with time and to cope with such stringency and meet their expectations, RWD and RWE will be best suited for safety data collection related to high-risk devices.

The major benefits that RWD and RWE are capable of providing are as follows:

  • The data that is generated is in-depth and caters to several aspects of the device based on real evidence.
  • Serves as the most time and cost-efficient procedure in clinical data collection.
  • It helps in retrieving such data that are of much value in making evidence-based changes to the medical device.

EU MDR and IVDR are trying to ensure that the best quality product reaches the patients and at the same time holds safety to be the priority. In such a situation, Real World Data needs to be given its due importance as this would increase patients’ reliability not only on the system but even on the medical devices. This might be equally benefitting for both patients and manufacturers as they too can easily fulfill the EU MDR requirements and even gain the confidence of the patients.