Versatility of data is great, but how do you track it? How do you ensure that all pivotal data captured while creating one report has also been transferred to another? Manufacturers usually have a very robust QMS system for handling their internal data. They have a systematic approach for handling and updating their internal documentation. However, systematically handling and keeping track of data gathered from external sources is a challenge. Mostly because there are multiple sources of information like we saw, and no two sources give the same kind of interaction to the user.
Let’s look at an example of literature sources. Now, no two sites that you see will have the same interface, and the format of data that is exported from these sites can vary. There is a need for a systematic process to gather and store information from these databases as a uniform data set.
Notified bodies are now interested in how you gathered your information and what strategy you follow to get to your pivotal data. One must also keep in mind the intended audience for this report and how to present data in a way which is clear and easy to understand.
I’d also like to highlight that every update that you make to your report, you will have a new set of data gathered for that review period. Notified bodies are focusing on clinical evidence and support for the device or the device technology. We’ve had instances where the notified bodies asked us to expand the date range of the searches. Instances like these where you have to search, consolidate, and track large data sets from multiple sources are very labor intensive and a huge resource burden.
It is 2021. Your end user is educated, curious, and has access to a lot more resources and information. You have increased awareness of the device status and how long the device has been on the market. Additionally, if it was ever recalled or had any field safety corrective actions against it, that can be accessed by the public. This publicly available information will allow users to make more informed decisions when choosing a device, or when a device is recommended to them.
Data published on EUDAMED can provide manufacturers a competitive advantage. They now have access to competitor data that they could not view before. One can use this data to guide and improve their devices design and risk calculations.
An increased emphasis on PMS will improve the manufacturer’s understanding of their device’s clinical benefits. Apart from meeting compliance requirements, we are looking at an increased level of safety for devices, and the industry overall.
There are also commercial advantages to this. Legacy devices that did not require clinical trials are now required to provide safety data. It may not be financially worth the investment to bring them to MDR standards based on low sales or profitability.
For the UDI – UDI aligns the manufacturers and other stakeholders in the supply chain to reduce counterfeit products. They can improve inventory management, even identify flawed devices, reduce medical errors, provide more information to patient treatment, facilitate worldwide medical device identification, and also give manufacturers an increased lead time to identify issues. These benefits may be utilized in the long-term, but in the short term, a lot of companies are still struggling to be ready for the EU MDR.
As a manufacturer, it is wise to consider a consulting firm or regulatory service provider to overcome these challenges.