EU MDR Post-market Surveillance System
The European Medical Device Regulation 2017/745 requires establishing a post-market surveillance system once the medical device is on the market. The EU MDR Post-Market Surveillance requirements will be explained below:
PMS system is established for the following:
- For each device: variants can be grouped for a device but the PMS system must be established for each device
- manufacturers shall
- plan: PMS plan prepared
- establish: this term is not defined in the MDR but can be understood as “put in place”
- document: documents prepared such as plans, templates, reports
- implement: activities to be carried out
- maintain: keep the PMS system operating at all times: in case of lack of personnel, lack of resource, system down, etc…
- update: review and revise if necessary
- a post-market surveillance system in a manner that is
- proportionate to the risk class: this impacts several areas. For instance: the amount of data source to review, the criteria the benefit-risk factor determination, the frequency of update of the post-market information.
- appropriate for the type of device: first a rationale should be provided in the PMS documentation to confirm if this is appropriate. Then a customer and user survey can be fine for class I devices but it will not be sufficient for a class III. Also, the location of the data must be relevant: no need to look in countries where the device is not sold unless data for similar devices is needed.
- That system shall be an integral part of the manufacturer’s quality management system referred to in Article 10(9): procedures and templates should be in place, referenced in the QMS, and implemented as such. For instance: post-market surveillance procedure, PMS plan template, PMS report template, etc…
Use of the data collected during PMS should be used:
(a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
First of all, there should be some criteria defined for the determination of an acceptable benefit-risk ratio.
The criteria can be documented in the CER and confirmed based on collected data. In the CER itself, there is some post-market data included.
- If any clinical investigation is conducted, there should be some comparison between the success rate of the treatment weighed against the adverse events detected during such clinical trials. For instance, a success rate of 90% against an adverse event occurrence of 3%.
- If a literature search is conducted, the same logic should be applied across all publications where clinical data is collected. An overall success rate can be determined and an adverse event rate as well.
- If possible, in some regions, the number of treatments using the same product or similar kind of product should be assessed. Then the adverse events collected and counted. A rate of adverse event should be estimated accordingly. It is possible to extrapolate the data from one country (such as USA) where more data is available to the rest of the world by applying a correction factor. Then based on the output it can be compared with the ratio obtained with clinical data for consistency. A criterion should be defined to compare the ration obtained with clinical data vs. post-market data. The criteria should consider an increase in the frequency but also on the severity of incidents.
The incidents can be categorized as follow: serious incident, non-serious, undesirable side effects.
Whenever the post-market or clinical data is updated (annual update for instance), new data is collected and should be compared the same way with the initial determined benefit-risk ratio.
The requirement is to update the “benefit-risk determination” so it is not only limited to the benefit-risk ratio. The method of evaluation of the benefit-risk can also be reevaluated.
(b) to update the design and manufacturing information, the instructions for use and the labeling;
There are 2 parts to this:
- Full PMS report update: there should be a section at the end of the EU MDR PMS report to document if the design, manufacturing, IFU, and labeling need to be updated. This should be taken to the change control process.
- When a single event happens: there is a change control process in place for a single event that should take care of this. The forms used to capture adverse events, complaints should include some a section to decide if an immediate change is required on the design documentation, manufacturing information, and labeling.
(c) to update the clinical evaluation;
Besides the benefit-risk ratio, the determination of the impact on the clinical evaluation has to be evaluated. For instance: off-label used, new adverse events, increase in adverse event rate.
- EU MDR PMS report to determine if CER requires an update: dedicated section for this
- A single incident or complaint received requires an update of the CER: specific section to be prepared for this effect.
(d) to update the summary of safety and clinical performance referred to in Article 32;
This update is done indirectly since the SSCP should be updated based on the revision of the CER for instance. However, it is also preferable to have a dedicated area in the EU MDR PMS report and PMS documentation to make sure that SSCP is also updated.
The SSCP can be also updated based on the revision of the CER.
(e) for the identification of needs for preventive, corrective or field safety corrective action;
- PMS report to determine if CAPA or Field Action is required: dedicated section for this
- A single incident or complaint received requires a CAPA or Field Action: a specific section to be prepared for this effect.
(f) for the identification of options to improve the usability, performance and safety of the device;
- PMS report should categorize adverse events in those 3 parts: usability, performance and safety. Then a decision should be made at the end of the report to confirm if there is an impact on the performance claims, safety and usability documentation.
- Single incident or complaint received could also be categorized (usability, performance and safety) and then there could be a determination of any impact: specific section to be prepared to this effect.
(g) when relevant, to contribute to the post-market surveillance of other devices
Define if other devices are:
- devices from other manufacturers: proactive report of the problems found
- other devices from the same manufacturer: for similar technology, define if the problems found have any impact on the other products from the same manufacturer
(h) to detect and report trends in accordance with Article 88.
Trends are defined as per Article 88. Based on the objective and criteria defined in a) there should be a determination of the statistical increase of the incidents. This is in line with what has been defined so far.
EU MDR PMS plan
PMS plan content is defined in Section 1.1 of Annex III (Technical Documentation on post-market surveillance).
(a) 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: serious incidents and FSCA collected from database like MAUDE, frequency of updates. Data collected from PSUR should be consistent with other data in the PMS documentation.
- records referring to non-serious incidents and data on any undesirable side-effects. Incidents should be categorized as serious and non-serious. Non-serious incidents should be evaluated (maybe a different impact on the benefit-risk ratio).
- information from trend reporting: what information is subject to trending, what is the threshold.
- relevant specialist or technical literature, databases and/or registers: define the data source and how to search in the database of literature
- information, including feedbacks and complaints, provided by users, distributors and importers: define which category, location type of user, distributor, importer is selected. For instance, what is an acceptable response rate.
- publicly available information about similar medical devices: define which device, how to find where distributed, what is the impact on the state of the art.
(b) The post-market surveillance plan shall cover at least:
- a proactive and systematic process to collect any information referred to in point (a). The process shall allow a correct characterization 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: information collected should be evaluated against the performance claims established in the CER. Compare the incident rate for other products on the market with the product under evaluation
- 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 as referred to in Section 3 of Annex I: a sort of validation of the method used (metrics and threshold) should be done and a conclusion on the effectiveness and appropriateness given
- effective and appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field: define methods like root cause analysis.
- methods and protocols to manage the events subject to the trend report as provided for in Article 88, 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: define the frequency of update. Define what is the impact on the frequency of the incident. The impact on the severity of the incident should also be determined.
- methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users: define who communicates with whom, what to communicate, when. There should be some process defined for that matter: flow chart for instance.
- reference to procedures to fulfill the manufacturer’s obligations laid down in Articles 83, 84 and 86: procedure number referenced
- systematic procedures to identify and initiate appropriate measures including corrective actions: reference CAPA procedure but also EU MDR PMS procedure and template where corrective actions are linked to PMS data
- effective tools to trace and identify devices for which corrective actions might be necessary: define traceability methods used and related tools (excel tracker for instance) for any Field Action implemented
- a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable: either document the whole PMCF plan in the PMS plan or add a reference to it.
Periodic Safety Update Report
Only for Class IIa, IIb and III.
The PSUR shall be prepared for each device of each group of devices (if relevant). The conclusions provided should include results and conclusion of the analysis of the PMS data: prepare a section from the PMS report (what to extract to PSUR).
A rationale and description of any preventive and corrective actions taken: Based on the data analyzed, PMS report PSUR section to include the CAPA taken.
Throughout the lifetime of the device concerned, that PSUR shall set out:
(a) the conclusions of the benefit-risk determination: extract from the EU MDR PMS report
(b) the main findings of the PMCF: in the PMCF prepare a section dedicated to the PSUR. Which information should be extracted? Or, at a minimum, determine if inclusion in the PSUR is required.
(c) the volume of sales of the device and an estimated evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device: normally this information is included in the CER. If possible, the definition of the frequency of use of the device shall be done.
Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III: PMS report does not need to be updated annually, so there are 2 options:
- a simplified review of the PMS data every year to determine of the PSUR should be updated. Then whenever PMS report is updated, more comprehensive impact analysis on the PSUR should be performed
- For every single post-market event throughout the year, the impact on the PSUR should be evaluated.
PMS plan + (PMS report OR PSUR) are included in the technical documentation.
|Class I||Class IIa||Class IIb and class III|
|PMS report||Update when necessary||N/A||N/A|
|PSUR||N/A||When necessary and at least every 2 years||When necessary and at least every year|
You may go back to our EU MDR guide.