Post-Market Surveillance requirements for Medical devices as per EU MDR 2017/745
MDR Article 83 outlines the requirements for Post-Market Surveillance systems under the new regulatory framework. Every manufacturer is required to plan, establish, document, implement, maintain and update a PMS system for every medical device. The system must be designed and documented in a PMS plan and then constantly updated according to a structured assessment of how well it is working and ongoing analysis of the data it has yielded.
MDR Article 83 requires that data generated by Post-Market Surveillance systems is used in specific ways; in particular, it should be used to:
- To update the benefit-risk determination and to improve the risk management
- To update the design and manufacturing information, the instructions for use and the labelling;
- To update the clinical evaluation;
- To update the summary of safety and clinical performance
- For the identification of needs for preventive, corrective or field safety corrective action;
- For the 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; and
- To detect and report trends
A well-designed PMS system will monitor the safety and performance of a medical device through two complementary domains:
-
- Post-Market Clinical Follow-up (PMCF): Post-Market Clinical Follow-up that involves the design and conduct of clinical studies to proactively and continually assess device safety and performance
- Vigilance systems: Vigilance systems that monitor and respond to complaints, adverse events, media reports, serious incidents and FSCAs
Documents must be produced in relation to MDR PMS systems
MDR Annex III provides useful details about what technical documents must be produced in relation to Post-Market Surveillance.
Post-Market Surveillance Plan
All MDR PMS systems require a PMS Plan that describes in detail how the system will collect and analyse safety and performance data. A well-written PMS Plan will account for using data from a wide range of different sources including:
- Serious incidents
- Field Safety Corrective Actions (FSCAs)
- Information from trend reporting;
- Databases and/or registries
- Feedback and complaints, provided by users, distributors and importers; and
- Publicly available information about similar medical devices.
MDR Annex III outlines rules for constructing the PMS Plan. As a minimum the PMS plan should contain the following:
- A proactive and systematic process to collect any information. The process shall allow a correct characterisation of the performance of the devices and shall also allow a comparison to be made between the device and similar products available on the market;
- 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 analyse market-related experience collected in the field;
- Methods and protocols to manage the events subject to the trend report, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;
- Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
- 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; and
- A PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable
Post-Market Surveillance Report
Manufacturers of class I devices shall prepare a Post-market Surveillance Report summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 of EU MDR 2017/745together 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.
Periodic Safety Update Report
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 summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 of EU MDR 2017/745 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:
- The conclusions of the benefit-risk determination;
- The main findings of the PMCF; and
- 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.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years.
A methodical approach to report design is always advantageous! With a proven track record of over a decade, MakroCare has optimized these procedures to ensure quality and success for manufacturers. Reach out to us now to overcome challenges in post-market surveillance!
