PMS, PMCF & PSUR

New requirements for post market surveillance for Medical Devices. How to interpret the Annex III of the EU 2017/745(MDR) and EU 2017/746 (IVDR)

Post Market Surveillance (PMS) requirements are impacted with the entry into force of the Medical Device (MDR) and In Vitro Diagnostic Regulations (IVDR).

PMS requirements for manufacturers are described in Article 83 of MDR, Article 78 of IVDR and Annex III  of both regulations specify the PMS plan as a technical file requirement for devices other than custom made .

For each device, manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system which shall in particular be used:

(a) to update the benefit-risk determination and to improve the risk management;

(b) to update the design and manufacturing information, the instructions for use and the labelling;

(c) to update the clinical/ performance evaluation;

(d) to update the summary of safety and clinical performance;

(e) for the identification of needs for preventive, corrective or field safety corrective action;

(f) for the identification of options to improve the usability, performance and safety of the device;

(g) when relevant, to contribute to the post-market surveillance of other devices;

(h) to detect and report trends.

The technical documentation shall be updated accordingly.

If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified, or a field safety corrective action is implemented, it shall be reported according to documented procedures.

Post-market surveillance plan

The regulation requires a post-market surveillance plan which 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; and

— publicly available information about similar medical devices.

And the followings shall be covered in this plan:

— 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 (PMPF) plan for In Vitro Diagnostics (IVDs), or a justification as to why a PMCF/PMPF are not applicable.

Post-Market Surveillance Report and Periodic Safety Update Report

Manufacturers of class I devices and Manufacturers of class A and B IVD’s shall prepare a post-market surveillance report and Manufacturers of class IIa, class IIb and class III devices and Manufacturers of class C and class D IVD’s 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/ Article 80, 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/ Article 81, 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:

(a) the conclusions of the benefit-risk determination;

(b) the main findings of the PMCF/ PMPF;

(c) 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 and manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. Manufacturers of class C and D devices shall update the PSUR at least annually.

For any questions on this topic and to get assistance on setting up your PMS PMCF plans you may contact our expert team

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