PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance.
The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall be planned and implemented carefully as part of the post market surveillance plan.
PMS requirements for manufacturers are described in Article 83 of MDR and Annex III, whereas the details of the PMCF are given on part B of Annex XIV. In short, PMCF is a continuous process which provides updated data to clinical evaluation. In most cases, especially during the transition period of MDR, it can be used as an effective tool to collect data about a medical device, which has been CE Marked under MDD. This may prevent for most Class IIb implantable and Class III devices a mandatory clinical investigation for CE marking under MDR.
In other words, with a well-designed PMCF plan, the manufacturer can collect and evaluate clinical data from the use in or on humans which is already placed on the market or put into service. PMCF shall aim confirming the safety and performance throughout the lifetime of the medical device. As usual the plan and data gained throughout the process shall be used and evaluated within the risk management process which has been designed according to ISO 14971:2019.
Article 10 General obligations of manufacturers: Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. So if you cannot justify why a PMCF plan is not required, regardless of your device risk classification you must have a PMCF plan and implement it as part of your post-market surveillance plan. This shall be in line with the requirements listed on Part B of Annex XIV.
Post Market Surveillance Requirements
Article 83 of the MDR requires that for each device, manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system which shall in particular be used to update the following.
- the benefit-risk determination and to improve the risk management
- the design and manufacturing information, the instructions for use and the labelling
- the clinical/performance evaluation
- the summary of safety and clinical performance
A PMS system shall also enable inputs for the identification of needs for preventive, corrective or field safety corrective actions and options to improve the usability, performance, and safety of the device. When relevant it shall contribute to the post-market surveillance of other devices and detect, report trends as specified in Article 88.
All these data shall be part of the technical documentation on post-market surveillance specified Annex III and updated continuously.
In order to establish the compliance objective with the MDR requirements the post-market surveillance plan shall address the collection and utilization of available information, in particular;
- information concerning serious incidents, including information from PSURs, and field safety corrective actions
- records referring to non-serious incidents and data on any undesirable side-effects
- information from trend reporting
- relevant specialist or technical literature, databases and/or registers
- information, including feedbacks and complaints, provided by users, distributors and importers
- publicly available information about similar medical devices
- a proactive and systematic process to collect any information
- effective and appropriate methods and processes to assess the collected data
- suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit- risk analysis and of the risk management
- effective and appropriate methods and tools to investigate complaints and analyses market-related experience collected in the field
- methods and protocols to manage the events subject to the trend report
- methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users
- reference to procedures to fulfil the manufacturers obligations for PMS system, PMS Plan and Periodic Safety Update Report (PSUR)
- systematic procedures to identify and initiate appropriate measures including corrective actions
- effective tools to trace and identify devices for which corrective actions might be necessary
- a PMCF plan for Medical Device or Post-Market Performance Follow up
One of the best strategies to be have a compliant PMCF plan with the requirements of Annex XIV is to make use of the MDCG 2020-7. The introduction section of the guidance document gives an overview of the requirements which are detailed in 7 Sections. Using a similar plan format and making a clear and solid justification if one of the sections is considered as nonapplicable, will decrease the debates with the notified bodies during the technical documentation review.
Similar to the PMCF plan format MDCG 2020-8 defines a very basic PMCF report template, which enables the documentation of the data collected during the process. The important thing is data the clinical data is gathered in line with the requirements and used as an input to the clinical evaluation process of the manufacturer.
If you need any help customizing your PMCF plan or report format you may contact our experts. They will be happy to help.
Periodic Safety Update Report (PSUR)
In addition to the PMCF requirements, manufacturers of class I devices shall prepare a post-market surveillance report and manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (PSUR) for each device and where relevant for each category or group of devices.
According to Article 85, a PMS report shall summarize the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. The report shall be updated when necessary and made available to the competent authority upon request.
According to Article 86, PSUR shall summarize the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan together with a rationale and description of any preventive and corrective actions taken. PSUR shall set out the following topics throughout the lifetime of the device concerned.
- the conclusions of the benefit-risk determination
- the main findings of the PMCF
- the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device
Again this process is continuous one.Manufacturers of class I devices do not have to prepare a PSUR; instead, they should prepare a Post-Market Surveillance Report (PMSR) as detailed in Article 85.Manufacturers of class IIb and class III devices shall update the PSUR at least annually and manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
You can find detailed information on MDCG 2022-21 Guidance on Periodic Safety Update Report (Psur) According to Regulation(EU) 2017/745 (MDR).