PMS and clinical evaluation report are essential in the continuous assessment and improvement of medical devices throughout their lifecycle.
While PMS focuses on gathering real-world data on a device’s performance, safety, and any emerging issues after it reaches the market, CERs are important in evaluating the clinical evidence supporting the device’s effectiveness before and during its use.
Together, these processes create a dynamic feedback loop that ensures clinical evaluations are constantly updated with the most relevant and up-to-date information.
This synergy not only enhances the safety and performance of medical devices but also helps manufacturers stay compliant with regulatory requirements, ultimately benefiting patients, healthcare providers, and the broader medical device industry.
Understanding PMS and Clinical Evaluation Report
Post-market surveillance refers to the follow-up of performance on a marketed and used medical device by patients and healthcare professionals. PMS looks for newly emerging safety concerns, assesses the long-term clinical performance of the device, and ensures that the product meets all the regulatory requirements throughout its entire life cycle.
The PMS process collects data from different sources that include user experience, adverse reports, and actual usage information. This therefore allows the possible identification of trends and high-risk areas, beginning any remedial action that is required.
Extensive records that summarize clinical information related to a medical device are known as Clinical Evaluation Report or CERs. This process seeks to evaluate and demonstrate that the gadget.
Synergies Between PMS and CERs
Although PMS and CERs operate towards different purposes, there are quite a few aspects in which these complement each other to present an effective platform ensuring the constant safety and functionality of medical devices. Synergies involved can be articulated in the following critical areas:
1. Continuous Data Integration and Update of CERs
Among other big synergies related to PMS/CERs, the integration of post-market data into clinical evaluation comes at the top. That is because PMS generates real-world evidence about how a device performs, including adverse events, side effects, and patient outcomes, which can form updates and refinements of a CER.
The regulatory bodies demand that the CER should be the most updated clinical information, and PMS provides a continuous flow of data that can be used to ensure the CER is accurate and comprehensive. According to the MDR (specifically Article 61, Annex XIV), the clinical evaluation report must be updated regularly, and one of the primary sources of new data for the CER is the information gathered during PMS activities.
Post-market data can provide new insights, which may result in an updated CER reflecting any new safety or performance concerns or confirming the device’s continued clinical effectiveness.
By incorporating PMS data into the CER, manufacturers can ensure that their clinical evaluation considers not just the controlled settings of clinical trials but also the real-world experiences and potential risks associated with broader patient populations.
This helps to maintain the device’s market authorization and prevent discrepancies between pre-market and post-market assessments.
2. Enhancing Risk Management
Both PMS and CERs are integral components of a device’s risk management strategy. PMS provides a dynamic, ongoing process for detecting and managing risks as the device is used in clinical practice, whereas the CER is primarily concerned with evaluating the known risks at the time of approval and their management in clinical settings.
The data coming out of PMS activities like post-market studies, device-related complications, or adverse event reports can feed into the risk analysis, which then will be amended and updated within the CER.
For instance, PMS identifies new safety concerns or performance issues not detected before clinical trials, such that this is used to update the CER’s risk-benefit analysis and continue the device’s safe and effective performance.
PMS as evidence for re-assessing the risk-benefit balance also guides corrective actions, such as changes in device design, additional safety measures, or labeling modifications.
3. Improving Clinical Evidence and Decision-Making
Another critical link between PMS and CERs is that these allow the improvement of clinical evidence from real-world data. Although the conditions under which clinical trials are done are controlled, the real-world environment has more challenges and variability than clinical conditions.
Real-world evidence is what PMS captures-for example, demographics of patients using the device, how it would perform in diverse clinical settings, and other unpredictable complications.
This information adds to the clinical trials and literature data used in the CER, thereby building on the strength of clinical evidence.
The new patient groups that have been found, the performance change in devices, or the trends of the product coming into being, are documented as part of the CER.
This, of course, increases the strength of the clinical evidence and allows the decision regarding further use of the device. Manufacturers also gain an opportunity to proactively address regulators and other stakeholders on a clear stance.
In this light, PMCF is a core part of PMS. This involves studies performed after a medical device has entered the market to review its performance under real-life conditions.
The conclusions drawn from the results of such studies should form part of the CER to ensure that the manufacturer reflects up-to-date information and continues monitoring the performance of the device.
4. Regulatory Compliance and Documentation
To regulate compliance in these global markets for many, specifically within the MDR and IVDR of the European Union, PMS is necessary, much like CERs.
A clinical evaluation periodically needs to be updated based on the most modern clinical data accumulated, which could include information based on PMS.
Such post-market clinical follow-up data underpins the life-cycle plan maintaining the compliance required so that at any point the device is deemed compliant with any applicable regulations that the device shall follow.
Being a part of CER updating, PMS data can be evidence of whether the manufacturers have complied with regulatory requirements up to the new regulatory requirement established. This process also enables the manufacturer to respond to regulatory authorities and stakeholders transparently and proactively.
In this regard, the role of PMCF, which is part of PMS, is crucial because it involves clinical studies conducted after the device is marketed to assess its real-world performance. The results from PMCF studies should feed directly to the CER so that manufacturers can reflect the latest findings and ensure clinical evaluation continues.
5. Facilitating Corrective and Preventive Actions (CAPA)
CAPA: One of the outcomes of PMS is the identification of areas for corrective and preventive actions. Once a device is established with performance or safety issues, PMS data may trigger the CAPA process in terms of device alterations, additional studies, or more extensive labeling to minimize risks. Findings and actions taken through the results of PMS can be documented and reflected in the CER.
It serves as evidence of the manufacturer actively engaging with newly identified issues by the regulators and stakeholders and makes sure that risk mitigation strategies of the latest developments would be incorporated into future clinical evaluation. Moreover, the ability of PMS activities to improve or correct the device’s design or usage can augment the credibility of the CER.
Conclusion
The collaboration between post-market surveillance and clinical evaluation reports would be a core element in providing ongoing safety and effectiveness of the medical devices. Post-market surveillance with real-world data integrated into clinical evaluation would, therefore, add strength to manufacturers’ risk management strategies, help improve the quality of clinical evidence, and assist in staying up to date with regulatory requirements.
This synergy supports manufacturers in easily identifying potential problems, taking correctional actions in case of some errors, and further enhancing overall device performance. Manufacturers who deploy both PMS and CERs are actually complying with statutory requirements and, therefore, also adhere to the idea of continuous improvement and patient safety.
All three parties involved — that is, the patients, health care providers, and the industry as a whole — benefit from this preventive, data- driven approach when it comes to the safety and efficacy of a medical device.
Author Name : Athira Unnikrishnan
Author designation: Junior Consultant (CER)
References
1. European Union, MDR 2017/745 (2017). Medical Device Regulation (EU) 2017/745.
2. MDCG 2020–13, European Commission (2020).
3. European Commission, MDCG 2020–8 (2020).