The European Medical Device Regulation (EU MDR) is excessively replacing the regulatory framework for medical devices. One of the new significant challenges is the increased focus on clinical proof and Post-Market Surveillance (PMS).
A recent article published by Emergo by UL warns that medical device companies will have to place a greater emphasis on gathering clinical and safety data as a result of this new requirement. In order to meet these goals, Periodic Safety Update Reports (PSURs) must be submitted on a regular basis. Operations become more complicated and market access and analysis become more costly as a result.
Post-Market Surveillance (PMS) has a tendency to become a significant part of the healthcare approval process for any CE-certified medical device, which will need manufacturers to acknowledge and carry out a new and relatively sophisticated procedure. For your convenience, we have put together an overview of everything that you will need to know about everything that you will need to know right here. Is it possible, however, to make post-market surveillance of medical devices an important part of the regulatory framework once they have been put on the market? And for what reason should we accept the EU MDR Post-Market Surveillance conditions for medical devices rather than question them?
Evidence-based on clinical trials: the elephant in the room:
Several years ago, a European breast implant manufacturer was empowered to sell non-medical grade implants. It generated a global health panic. More than 30.000 women were advised to remove their implants and there were many people who suffered serious health problems and even death.It convinced people that this case was one of the main drivers behind the increased focus on PMS in the MDR. However, if you look at the area of the industry and the number of devices applicable, the danger of a similar case repeating is important.
Process of market approval today:
The fact is that most devices (in the EU and USA) have been accepted for marketing by uniquely proving ‘equivalence’ to a previously legally marketed device – without necessarily accompanying long-term clinical benefit or safety. This has been a quality process for market approval for a long time. However, the term ‘equivalence’ can be somewhat confusing. Especially when you look at the number of devices that have been accepted through this procedure and how far back the original approval has gone.
This shows that a new device that might not pursue the same design, look, or be possessed of the same materials, could be marketed to supply the same clinical value and safety as the predicate device. The problem with this process is that medical technology is not that straightforward.
With the progress and speed of development in MedTech, it can be difficult for regulators to keep up with the industry. But it is understandable that the EU acknowledged that something had to change, in order to decrease the risks of new safety issues.
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Post-market surveillance: A key factor to the improvement of medical devices.
It is hard to state that by eliminating the ‘equivalence rule’ and replacing it with a more harsh clinical-trial requirement (similar to the pharmaceutical industry), perhaps we could have safer or more effective devices But, it looks like EU regulators have acknowledged that the issue is not certainly associated to the approval process, but rather than the shortage of data to support the claims – especially in the long run. Now Post-Market surveillance plays its role. Post-Market surveillance is designed to supervise the safety of drugs once they reach the market, following the successful achievement of clinical trials.
The main purpose for conducting postmarketing surveillance is to identify the previously unrecognized dangerous effects along with positive effects. Therefore upgrading the quality of treatment. Furthermore, the Post-market surveillance data can give producers of safe medical devices a well-defined competitive advantage over any dangerous devices that can be on the market.
Moving forward, it will be extremely hard to sustain healthcare approval if the safety and performance of a device cannot be continuously supported in real-life environments. Moreover, with quick access to information, healthcare consultants and purchasers are creating informed choices established on sources, data, and surveys. Therefore, it is possible that healthcare actors (and customers) will prefer medical devices that require evidence to support their claims, which will positively affect sales along with the success of these devices.
Thus, the result of Post-Market Surveillance of medical devices can be positive for both the industry and the public in the long term, besides it should be embraced rather than questioned. The procedure of collecting the data can be expensive, which explains why some MedTech companies turned out to be reluctant in conducting clinical trials or rigorous Post-Market Surveillance activities. This is mostly true for companies with little or no previous experience with post-market data collection and management. Organizing and executing Post-market surveillance without primality experience can be very complicated and end up being an extremely overpriced affair.
Additionally, Post-market surveillance data can be insufficient or futile by Notified Bodies if the Post-market surveillance plan and data collection methods are not accurate. We have always suggested medical device companies use pre-validated EDC software to make sure that data is collected and managed in a cooperative manner.
What is the future of the MedTech industry?:
If more data and medical device PMS is the foremost way to go But if you look at the progress in the industry, and you compare it to what has been happening in the Pharma industry for the past 20 years, it might not be as inadequate as it currently seems. Even though we might initially see a fall in the number of devices, it doesn’t change the fact that we have to think about the safety of patients. This is the reason why the industry should view this as a positive growth towards better healthcare and not just a hole in their checkbooks. Essentially, manufacturers want to get past the initial (and understandable) shock of the new MDR and move forward with PMS plans.