The PMCF – Post Market Clinical Follow-up is part of active modalities to perform post-market surveillance activities and the requirements related post-market clinical follow-up plan and report have been further expanded within the EU MDR 2017/745 . The PMCF is defined as the collection of clinically relevant information coming from postmarket surveillance.
The PMCF can be considered as a continuous process aimed at updating the results of the clinical evaluation; the modalities in which the organization is using to perform the PMCF shall be defined within the post-market surveillance plan. The post-market clinical follow-up is performed subsequently to introduction of the medical device in the European market, after CE marking has already been granted; the goal of PMCF is to ensure the device continues to meet safety and performance requirements through all the life time of the device.
The Post Market Clinical Follow-up Plan
Part B of Annex XIV of EU MDR 2017/745 clarifies in details what shall be addressed in the PMCF Plan. The PMCF plan is part of the technical documentation (MDR Annex II), thus it needs to be submitted to the notified body for review
Specifically, the PMCF plan shall include the following information:
- the general methods and procedures of the post-market clinical follow-up to be applied;
- the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or clinical studies;
- a rationale for the appropriateness of the methods and procedures mentioned above
- reference to clinical investigation report and risk management
- the specific objectives to be addressed by the post-market clinical follow-up
- an evaluation of the clinical data relating to equivalent or similar devices
- reference to any relevant CS (common specifications), harmonised standards when used by the manufacturer, and relevant guidance on PMCF
- a detailed and adequately justified time schedule for PMCF activities
Post-Market Surveillance Procedure
QualityMedDev provides a Post-Market Surveillance Procedure that defines all the requirements associated to PMS activities according to EU MDR 2017/745 and IVDR 2017/746. This includes PMS Plan, PMCF Plan and Report, PUSR, PMS Review, frequency of review and update of PMS processes, and much more. The procedure is a 10-pages word file, fully editable and ready to be amended in order to align the documents with the internal processes of your organization.
The Design of PMCF Activities
Many classic clinical investigation are hardly adapted to meet the requirements of the MDR for the PMCF: in fact, many clinical studies are designed to collect data for a limited amount of time and on a limited amount of users or patients. This means that standard clinical investigation are not suitable to meet PMCF requirements for longitudinal data collection through the whole lifetime of the device.
Example of methodologies / source of information that can used to collect information for the PMCF are:
- Device Registry
- Specific PMCF studies
- Real-world evidence
- Surveys
- A review of relevant retrospective data from patients previously exposed to the device.
- The extended follow-up of patients enrolled in premarket investigations
Medical Device Registry
Medical device registries are defined as an organised system that collects and maintains structured records on a specific disease, medical product etc. for a specific time period and population. A registry can range from ward based spreadsheet to large internationally harmonised registries.
Registry data are given specific emphasis in MDR; for example, in the Annex VI, notified bodies are requested to take registry data into account w/ recertification review, whereas in Annex XIII, manufacturers are requested to review suitable registry data as part of their post-marketing obligations.
Specifically, the registry can be a valuable source of information which can be used for PMCF activities in compliance with the MDR.
Specific PMCF studies
Specific clinical investigation can be performed as well in the framework of PMCF activities. It is important to mention that also PMCF studies need the approval from ethical committee. This can prove to be a time-consuming task, as ethical committees often require a formal application. Moreover, sometimes committees in different countries can react differently to the application and its contents.
Furthermore, it is essential to remind that any study shall always be compliant with GDPR. For this reason, it is essential to guarantee the correct security and safety measures (such as adequate encryption of data in storage or transmission) and to obtain clear informed consent from respondents/patients.
Real World Evidence
Real World Evidence (RWE) is clinical evidence generated from observational data on the real-world use of medical devices. RWE are really suitable to be used for PMCF activities for several reasons:
- Using RWE, it is possible to collect data related to the use of the device by the entire population, which is normally exposed to the device. This is a big advantage compared to standard clinical investigations.
- RWE are focused on safety and performance of the subject device.
- RWE studies the use of a device that is already CE-marked and it does not require experimental studies.
- PMCF using RWE can include an unlimited number of patients for an unlimited number of users.
- Finally, RWE is conducted at all types of clinical sites and does not select for centres of excellence. Thus, there is homogeneity in the source of data collection.
The PMCF Report
The MDR does not include detailed requirements on the contents of the Post Market Clinical Followup report. However, the MEDDEV 2.12/2 rev 2 – focuses on PMCF activities and gives some detail about requirements for PMCF Reports. This guidelines have not been updated yet based on the MDR requirements; however it still contains useful information on how to structure the PMCF report.
The PMCF report shall include all the information requested as per the related PMCF plan, introducing findings from the investigation at relevant points.
Moreover, it is essential that post-market clinical follow-up report, in case a specific PMCF study was conducted, is addressing as well:
- Adverse events
- Side-effect frequency and severity
- Systematic misuse of the product
- Safety and performance of the device in routine use
Finally, it is also necessary to explain the PMCF report wether the activities performed have been sufficient to address the full range of objectives specified in the plan.
QualityMedDev E-Book on Post-Market Surveillance
QualityMedDev recently published e-book of 36 pages that provides a practical guideline to post-market surveillance activities according to EU MDR 2017/745. This document represents a comprehensive overview of the medical devices PMS requirements for the European market. After all the changes introduced through the MDR, there has been the necessity of one unique document that explains and discusses the medical device post-market surveillance requirements.
Specifically, the topics covered by the e-book are:
- ISO 20416:2020 and the New Requirements for Post-Market Surveillance Activities for Medical Devices
- Deep Dive in the Post-Market Surveillance (PMS) Processes according to EU MDR 2017/74
- The Post-Market Clinical Follow-up
- Requirements Periodic Safety Update Report according to EU MDR
- Template for Periodic Safety Updated Report according to European Medical Device Regulation
- Vigilance Reporting Requirements according to EU MDR 2017/745
This Guideline on Post-Market Surveillance (PMS) Activities provides an overview of new processes such as PMCF (Post-Market Clinical Follow-up) and PSUR (Periodic Safety Update Report) and it includes as well an example of PSUR template. Moreover, an overview of the vigilance reporting system according to EU MDR 2017/745 is discussed.
Conclusion
In conclusion, the post-market clinical follow-up process will become an essential requirement for the European Medical Device Regulations at the interface between clinical evaluation, post-market surveillance and risk management.
