Post Market Clinical Follow up or PMCF is an essential part of on-going medical device compliance. PMCF has been a requirement for Medical Device manufacturers dating back to the EU medical device directives. However, the introduction of the EU Medical Device Regulations (MDR) EU 2017/745 has significantly strengthened PMCF requirements. This means that almost all medical device manufacturers are now required to complete PMCF activities if the place their medical devices on the EU market.
What is PMCF?
PMCF is a proactive data collection activity that forms one arm of Post-Market Surveillance (PMS), alongside Vigilance processes. Under the EU MDR, the main purpose of PMCF is to collect data relating to residual uncertainty on device safety or performance.
It is a proactive process that collects and evaluates clinical data on the safety and performance of a medical device in normal use. According the MDR Annex XIV Part B, PMCF should run on a continuous basis throughout the entire lifetime of a device.
It is essential that medical device manufacturers have a solid understanding of PMCF requirements under the EU MDR regulatory framework.
A detailed PMCF plan must be written for the medical device, this plan must be kept up to date, the PMCF plan must be written inline with the requirements set out in the EU MDR 2017/745 and MDCG guidelines. The plan is made up of 7 sections which detail all the required information on how PMCF will be carried out by the manufacturer to gather real world clinical data based on the residual risks identified within the Risk Management File and Clinical Evaluation Report. A PMCF study or survey must be designed to accommodate the characteristics, target patient and user population, risk classification and complexity of the subject device, meaning that experience in designing clinical investigations is vital in ensuring suitability for purpose.
What are the objectives of PMCF?
According to Annex XIV Part B of the MDR, overall objectives of PMCF are to collect and evaluate clinical evidence to assess the safety and performance of a medical device when used as intended. Specific objectives for PMCF under the MDR include:
- Identifying and investigating residual risks associated with use of the device
- Contributing towards the update of Clinical Evaluation
- Detecting any emerging risks and previously unknown side-effects
- Confirming the overall safety and performance of the medical device in normal use
- Identifying systematic misuse of the device and its impact on safety and performance
The design of PMCF studies and surveys should be documented in a PMCF Plan and results must be collated in a PMCF Report that forms part of the Clinical Evaluation Report (CER) for the device.
A PMCF study or survey must be designed to accommodate the characteristics, target patient and user population, risk classification and complexity of the subject device, meaning that experience in designing clinical investigations is vital in ensuring suitability for purpose.
A PMCF plan must be put in place for each type of medical device placed on the market, this information is placed within your post market surveillance section of your technical file. A PMCF report must be generated at least once per year to gather on going information collected in the real-world setting.
Clinical Investigations (including medical device registries and PMCF surveys) must adhere to all legislative requirements related to the performance of medical research.
Specific requirements for designing, conducting and reporting Clinical Investigations are documented in MDR Annex XV. Investigations must also conform with GDPR requirements on data collection and should meet the standards of Clinical Investigation conduct outlined in ISO 14155:2020 and GCP guidelines.
For all PMCF investigations, documents should include:
- A Clinical Investigation Plan (CIP) or protocol that outlines how the PMCF study must be conducted
- An Investigator’s Brochure that specifies responsibilities for the principal investigator at each clinical site
- A patient information leaflet and consent form that ensures patients are fully informed and documents the process of informed consent
PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered.
PMCF surveys or ‘end user’ surveys are a valid method of collecting post-market clinical data. They can be used to gain information on a device and its use from both healthcare professionals and patients by providing a set of questions to be answered. These questions should be carefully considered for each device. The nature of the product and the target population will inform the types of questions asked.
These are not the usual ‘marketing’ survey. This is a clinical data generation tool.
The nature of the survey can vary. They can be general or specific – for the lower-risk devices and established technologies then a more general survey on user feedback can be utilized. For products in the high-risk categories a manufacturer should consider a more specific survey activity.
General surveys tend to be retrospective design – asking the end-user to recall information on the device and its use.
Specific surveys can be patient level and case specific – this can be a single survey or a series of surveys that follow the usage of the devices (prospective). This could be direct to the patient or via a healthcare professional using patient records. The data obtained from this type of activity will be of higher quality – usually producing clinical data on the devices under review via patient outcome data and clinical indication data.
A Post-Market Clinical Follow-up (PMCF) Report (also known as a PMCF Evaluation Report) is a structured report that summarises the findings of PMCF activities conducted in relation to a medical device. The Medical Device Regulation – MDR 2017/745 – significantly elevates the importance of PMCF compared to its level of prominence under the predecessor legislation, the Medical Device Directive MDD 93/42/EC.
Detailed rules for PMCF under the MDR are set out in Annex XIV Part B. All PMCF must be conducted according to a written PMCF plan, submitted as one component of the technical documentation needed for regulatory scrutiny along with the device itself.
Periodically, findings from PMCF must be summarised in a PMCF Report, with the contents of the Report also forming part of the Clinical Evaluation Report (CER) for the device.
PMCF objectives should focus on areas such as:
- Adverse events
- Side-effect frequency and severity
- Systematic misuse of the product
- Safety and performance of the device in routine use
Therefore, data relating to each of these areas generated through PMCF studies can be summarised under the appropriate heading in the PMCF Report.
The report should also contain a summary of methods used to generate the data, and information about any method alternations that may be required for future PMCF activities. An assessment should also be made as to whether PMCF activities have been sufficient to address the full range of objectives specified in the plan.
How can Patient Guard Help?
Patient Guards experts and medical writers can support you with your PMCF planning and documentation requirements and provide ongoing support to you should you require regulatory advice and documentation creation around clinical study and clinical survey set up. We can also provide assistance in writing PMCF Reports and assistance in how this information is used to demonstrate state of the art in terms of your continuing clinical evaluation report updates.
Contact us to discuss this in further detail.