Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always the ever-present vigilance regarding the safety of the device.
Medical device manufacturers follow several guidelines to ensure that adverse health consequences do not happen. They follow the EU regulations, as well as the International Organization for Standardization (ISO), among many others. The good thing about following general manufacturing standards is that the occurrence of factory adverse events or misuse-related adverse events happens less frequently. However, the medical device is not just any other device. Adverse events can and do happen even when the device is used in a completely regular environment. And since it’s a medical device, the fall-out for an adverse event is much larger than a regular device.
So, medical manufacturers have to be meticulous about risk assessment all the time. At every stage of development, safety and risk assessment is kept in mind, and associated steps are taken.
One of the things they do involves a clinical evaluation of the device to assess its safety and efficacy. It is usually done during clinical testing. However, medical device manufacturers must also implement risk management and post-market surveillance activities to ensure that the device is safe and effective over its entire lifecycle.
In this article, we’ll take a closer look at how risk management and post-market surveillance interact with the clinical evaluation of a medical device and how it all comes together to make a safer device for patients.
Risk Management and its clinical side
According to the EU MDR, medical device manufacturers must “establish, document, implement and maintain” a risk management process.
Risk management is not a single step. It’s a systematic, planned process that helps manufacturers detect, assess, and manage any possible dangers connected to the use of medical devices. It is mandatory for manufacturers to set up, and for good reason.
As part of the risk management, the manufacturer will also:
- List and analyze the known and anticipated risks related to each device
- Assess and calculate the risks related to, and occurring during, the intended use and reasonably foreseeable misuse
- Eliminate or control the risks.
- Assess the information from the production phase, particularly from the post-market surveillance system, on risks, their frequency of occurrence, and estimates of their associated risks, as well as the overall risk, risk-benefit ratio, and risk acceptability.
To complete any of these above-mentioned requirements, one needs clinical data. Clinical evaluation allows manufacturers to gather data and safety information based on the actual usage of the medical device in a clinical setting. This real world evidence is far more accurate in predicting and catching risks than any hypothetical situation.
All possible dangers connected to the device, including those discovered during the risk management procedure, should be taken into account during the clinical evaluation. Manufacturers have a legal and moral duty to ensure that all risks are recognized and taken care of.
Post Market Surveillance and its Clinical Correlation
Post market surveillance, while done after the device is launched in the market, is almost completely based on clinical data.
According to the MDR, a post market surveillance plan should be drawn up before the device is launched. The post market surveillance also includes a post market clinical follow up. The goal is to:
- Ensure the device’s safety and functionality during the course of its anticipated lifetime
- Find previously undiscovered side effects and keep an eye on them, as well as any contraindications
- Detect and assess emergent risks based on factual evidence
- Guarantee that the benefit-risk ratio is consistently acceptable
- Locate potential off-label or systemic abuse of the device
When it comes to post-market follow-up, the clinical viewpoint is not just important; it’s kind of the only viewpoint. After the device is in the market, the only thing to assess is how it’s doing in terms of patient care and safety issues.
Post market surveillance or follow-up mostly comprises gathering and analyzing clinical data from the end users. Clinical studies, patient registries, and direct patient/end-user reach-out surveys are some potential places to find this data. The objective is to evaluate the device’s clinical efficacy and safety in a real-world environment over its anticipated lifetime.
Hence, the PMS activities mainly include carefully documenting, assessing, and reporting any new clinical concerns or unexpected adverse events. To guarantee patient safety and optimal device functioning, this constant monitoring helps in the early detection of possible risks, allowing for prompt preventive and corrective actions.
Clinical evaluation, PMS and Risk management plan
According to the MDR, the clinical evaluation, as assessed by the notified body, will have PMS data and a clinical evaluation report, among other things. They will also assess whether the manufacturer correctly fulfils the risk management requirements. So, in terms of medical device regulation, clinical evaluations, risk management, and post-market surveillance are all tied up together.
In terms of the safety and performance of the device, they are all connected, too. Post market surveillance aims to improve device user facilities as much as possible. The goal of risk management is also to reduce serious adverse health consequences. Neither is possible without accurate clinical data.
That is why including any new information gathered during post-market surveillance in the clinical evaluation report is important. That way, the clinical evaluation report will accurately reflect what is known about the device’s efficacy and safety right now. Any corrective and preventive action will be precise and useful.