New Requirements for Post-market Surveillance
The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which need to be implemented for a CE marking process.
A good post-market surveillance (PMS) system is composed by two different parts:
- Post-Market Clinical Follow-up
- Vigilance System
The post-market clinical follow-up is related to the design and implementation of clinical studies to assess clinical safety and performance of a medical device. The vigilance system, instead, is related to communicate to competent authorities events which had serious impact on the user or any other person.
Where are described the PMS requirements according to EU MDR / IVDR?
The EU MDR post market surveillance requirements are quite simulate for both the Medical Device Regulation (MDR) and the In-Vitro Diagnostic Regulation (IVDR. These requirements are described in Chapter 7 of both regulations (EU MDR and IVDR) plus specific annexes that describe more in details the requirement.
Post-Market Surveillance Plan
The PMS plan is part of the technical documentation and the EU MDR provides a detailed summary on what the PMS plan shall contain:
Specifically, any type of PMS plan shall contain the following:
- serious incidents and field safety corrective actions,
- non-serious incidents and undesirable side-effects,
- reportable trends,
- relevant information from literature, databases and/or registers,
- feedback, including complaints, from users, distributors and importers,
- publicly available information about similar medical devices.
Going more in details, the following items shall also be addressed by the PMS plan:
- the processes to be used to collect the data (in this case, ISO 20416:2020 could definitely help),
- the methods to be used to assess the collected data
- the indicators and thresholds to be used in reassessing the benefit risk,
- the methods and tools to be used to investigate complaints and other market feedback,
- the methods and protocols to be used to identify reportable trends,
- the methods and protocols to be used to communicate with stakeholders,
- reference to the PMS procedures to be followed – the PMS procedure within QMS of the organization.
- the procedures to be used to identify and initiate corrective actions (CAPA procedure),
- the tools to be used to trace and identify any devices in case corrective actions are needed,
- the PMCF plan or a justification why PMCF is not applicable. See also the dedicated page on Clinical Evaluation.
PMS System and Article 83 of EU MDR 2017/745
Article 83 of EU MDR reports the general requirements for the implementation of the post-market surveillance system. The requirements reported in Article 83 are the following:
- A post-market surveillance system is needed for each device. The system shall be commensurate with the class of risk of the device.
- The goal of the system is to collect information to ensure quality safety and performance of the device through its entire life time.
- The collected data shall be used for the following purposes:
- to update the benefit-risk determination and to improve the risk management;
- update the design and manufacturing information, the instructions for use and the labelling;
- Evaluate any update needed for clinical evaluation;
- Summary of safety and clinical performance;
- for the identification of needs for preventive, corrective or field safety corrective action;
- identification of options to improve the usability, performance and safety of the device;
- when relevant, to contribute to the post-market surveillance of other devices;
- to detect and report trends.
Post Market Surveillance Report and Periodic Safety Update Report
The post-market surveillance requirements are defined within Article 85 and 86.
The PMS report is a requirement for low-risk devices; it should include a summary of the results of the analysis of PMS data mentioned in the PMS plan and a rationale whether any corrective action is needed or not.
The PSUR (Periodic Safety Update Report) is only for higher class of risk devices (Class IIa, IIb and III). It shall contain the same of what has been mentioned for the PMS report, plus the following:
- the main findings of the PMCF (Post-Market Clinical Follow up)
- conclusion of the reassessment of risk-benefit analysis
- data on sales volumes and estimates of user population and frequency of use