Market observation through PMS/PMCF

As a manufacturer you are requested to pursue active market observation and develop defined post market surveillance (PMS) strategies for each product or each product family. This puts you in the position to identify and eliminate rare complications and problems across the entire product lifecycle that could not be identified before placing the product on the market.

Activities for post-market surveillance may include: processing of complaints; surveying users, dealers and carriers; analyzing hotline feedback, social media forums or reviews from the app store; researching scientific literature or databases of surveillance authorities for incidents and recalls, as well as post-market clinical follow-up (PMCF). Any activity that does not relate to a specific incident is regarded as active. Together we develop a strategy that will allow you to integrate this data efficiently into your clinical evaluation and consequently to save a considerable amount of time and labor costs for the annual update.

Post-market clinical follow-up (PMCF) studies are so-called market observation studies conducted for medical devices with legitimate CE marking. The medical device in question must be used within its intended purpose; the study design may neither include additional invasive nor other stressful examinations. These studies serve the aim of generating further clinical data and incorporating it in the clinical evaluation report. As ISO 14155 does not differentiate between medical devices with and without CE marking, the standard is applicable to all studies/clinical investigations alike.

We structure your internal market observation processes and deliver ideas how you may incorporate this data into your clinical evaluation efficiently. If the results indicate that you need to conduct a PMCF study, we plan this study efficiently and ensure smooth implementation.

MDR: product lifecycle reporting

The MDR defines new responsibilities for you as a medical device manufacturer such as a regular preparation of plans and reports. Some updates follow a fixed schedule, others need to be integrated in this cycle reasonably.

The figure shows the plans and reports in a logical sequence. This makes it easier to identify interdependencies. The collection of clinical data must be planned already during product development. After approval you are in a continuous process of preparing plans and reports throughout the entire product lifecycle.

To comply with all requirements and be able to provide all documents in a timely manner, the individual stages need to be aligned carefully.
[CR #494746] @ MDR:  Product Life Cycle Reporting[/CR]

Explanation of the stages

+1 - CDP - Clinical Development Plan
At the beginning of the development process, the clinical development plan defines how you will collect sufficient clinical data for later clinical evaluation. This may include exploratory investigations, first-in-man studies, feasibility and pilot studies, to confirmatory investigations; an outlook for possible PMCF activities is also possible at this stage.
+2 - CEP - Clinical Evaluation Plan
Prior to conducting the clinical evaluation, the clinical evaluation plan defines the scope of the clinical evidence. Available pre- and clinical data, remaining residual risks, newly identified risks (from PMS/PMCF/complaints) as well as all other claims (also from marketing) are considered. Afterwards, clinically relevant questions as well as open questions from risk management are derived. Finally, the search strategy is defined (sources, search terms, selection and evaluation criteria) that is to be applied for the clinical evaluation.
+3 - CER - Clinical Evaluation Report
The clinical evaluation report represents the results of the clinical evaluation. At this stage, clinical data is collected, selected, evaluated, and analyzed from the device or devices for which it has been demonstrated that they are equivalent to the device. It is checked whether the device meets the requirements for safety, performance, undesired side effects and the benefit-risk ratio defined by the MDR. Furthermore, currently available alternative treatment options also have to be taken into consideration. Finally, the need for further clinical data is discussed (PMCF activities) and passed on to PMS.
+4 - PMS Plan / PMCF Plan
In the PMS plan the manufacturer defines how the device will be monitored after the market launch and which data is to be collected. Product-specific planning of activities needs to take into account the findings from the clinical evaluation and the device’s risk potential. Furthermore, the methodologies for analyzing the data and the criteria for the analysis are defined. The manufacturer is responsible for collecting the data on the market proactively.

Post-market clinical follow-up (PMCF) is part of PMS. PMCF is to close the gaps that could not be answered in the scope of the clinical evaluation (e.g. long-term behavior, monitoring of side effects and contra indications). The PMCF plan describes methodologies and procedures for the proactive collection and evaluation of clinical data. The extent may vary considerably depending on the PMCF activities. Therefore, a PMCF master plan may well be established at this point that refers to different PMCF plans defining the individual activities.
+5 - SSCP - Summary of Safety and Clinical Performance
An SSCP report must be prepared only by manufacturers of class III and implantable devices. The report is referenced in the user manual or the label and is made publicly available via EUDAMED. The report must be written in such manner as to be comprehensible for laypersons. The purpose of the short report is to introduce the device in the context of its application and explain alternative therapeutic or diagnostic options as well as residual risks and undesirable effects. Prior to publication, the report is validated by the notified body, which will then upload the report to EUDAMED. Content and format of the representation may be defined by the commission.
+6 - Proactive PMS: Vigilance Report, PMCF Report, Trends
The proactive PMS phase is where you conduct your PMCF activities and collect and evaluate market data. The strategies you defined in the PMS plan have to ensure that reportable events such as vigilance cases and trends may be identified and reported in a timely manner.

Vigilance: Describes the reporting of serious incidents and field safety corrective actions to the authority. For this purpose, every manufacturer needs an appropriate system in which it is ensured that the evaluation and analysis of such events is enabled and that the deadlines for reporting them may be adhered to. Reporting is carried out via EUDAMED.

PMCF: The results of PMCF activities are documented and analyzed in one or several PMCF reports. The extent of analysis may vary considerably depending on the PMCF activity. The conclusions of the PMCF report must be taken into account for the PSUR/PMS report and furthermore for the clinical evaluation and risk management.

Trends: Statistically significant increases in the frequency or severity of non-serious incidents or expected undesirable side effects must be reported to the responsible authority provided they affect the benefit-risk ratio. By comparing your observations to the expectations from risk analysis, you will arrive at a conclusion whether an increase is significant. The PMS plan must define a methodology how to identify trends reliably. In addition, the observation period has to be defined.
+7 - PMS Report / PSUR
A PMS Report is created for class I devices and includes a summary of the results from market data collected over the last observation period. Based on these results, a conclusion is derived that is passed on to clinical evaluation. Furthermore, corrective and preventive actions are defined and explained. The purpose of the PMS report is to gain insights into the behavior of the device on the market across the entire product life cycle. These may then be used for further product development as well as for ensuring the device’s safety. That way it may be ensured that the device complies with the requirements of the regulation at any time.

A PSUR is prepared for class IIa, IIb, and III products. Like the PMS report, it includes a summary of the results from market data collected over the last observation period. Based on these results, a conclusion is derived that is passed on to clinical evaluation. Furthermore, corrective and preventive actions are defined and explained.
In addition to the topics of the PMS report, the PSUR also includes the conclusions from the benefit-risk assessment, the most important results from PMCF, and the total number of units sold as well as other information on frequencies, e.g. on application.
The purpose of the PSUR is to gain insights into the behavior of the device across the entire product life cycle. These may then be used for further product development as well as for ensuring the device’s safety. That way it may be ensured that the device complies with the requirements of the regulation at any time.

Our services in detail

Support and consulting services on post-market surveillance (PMS), e.g. by planning proactive market observation and developing PMS processes.

Creating reports required under the MDR:
  • CDP - Clinical Development Plan
  • CEP - Clinical Evaluation Plan
  • CER - Clinical Evaluation Report
  • PMS Plan/PMCF Plan
  • SSCP - Summary of Safety and Clinical Performance: for class III and implantable devices
  • Vigilance Report, PMCF Report, Trends (Proactive Post-Market Surveillance)
  • PMS Report and Periodic Safety Update Report (PSUR) for all class IIa devices or higher.

Metecon is your established and thorough partner for planning, conducting and evaluating all of these reports.