Medical Device and post-market surveillance

Di Annamaria Cimicata - Regulatory Affairs Manager

Article 2, considerando 60, of the Medical Device Regulation (EU) 2017/745 (MDR) provides the definition of Post-Market Surveillance, describing, in a highly simplified way, what Post-Market Surveillance (PMS) is, who should be in charge of it, and how:

Post-Market Surveillance means all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions”.

PMS should not be confused with market surveillance (considerando 61 of the MDR Regulation), understood as: “the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonization legislation and do not endanger health, safety or any other aspect of public interest protection”.

Finally, "vigilance" (borne by the Manufacturer, the Authorized Representative and the Competent Authority) is a reactive process and consists of reporting serious incidents and Field Safety Corrective Actions (FSCAs) to the Competent Authorities concerned. Side effects and expected adverse incidents trends, not classified as serious, should also be reported by the manufacturers. 

What is post-marketing surveillance
Post-market surveillance (PMS) is to be understood as the set of activities useful for establishing and keeping up-to-date a systematic and proactive procedure for collecting and analyzing information coming from the market, and concerning medical devices already placed on the market. 
Post-marketing surveillance activities must be performed throughout the entire life cycle of the device and allow useful data to be obtained to keep information on the quality, performance, and safety of the device up to date.
In fact, it is during the post-marketing phase, when the medical device is available on the market and its use by the population is widespread, that new risks, side effects, accidents, and adverse events, not considered and/or not foreseeable during the pre-marketing phase, might emerge.

Data gathered by the manufacturer's post-market surveillance system shall in particular be used 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;
  • update the clinical evaluation;
  • update the summary of safety and clinical performance (only for implantable and class III medical devices);
  • identify needs for preventive, corrective or field safety corrective action; 
  • identify options for improving device usability, performance, and security;
  • contribute to the post-market surveillance of other devices (when relevant); 
  • obtain information for reporting on device trends.

(Article 83 MDR)

Who should take care of it and how 
Post-market surveillance is mandatory for medical device manufacturers according to MDR Regulation. 
However, other economic operators (distributor, importer, authorized representative, where applicable) are also required to participate in the post-market surveillance process in cooperation with the manufacturer. The manufacturer, however, remains solely responsible for the activity on its device(s) with the task of preparing the technical documentation on post-market surveillance in accordance with MDR Articles 83 to 86.
The technical documentation on post-market surveillance shall be presented in a clear, organized, readily searchable and unambiguous manner and shall include in particular the elements described in the Annex III of the MDR. The post-market surveillance system shall be proportionate to the risk class and appropriate for the type of device and integrated into the manufacturer's quality management system.

In particular, the PMS documentation shall include the following:

  • a post-market surveillance plan (PMS plan);
  • a periodic safety update report (PSUR) for class IIa, IIb and III medical devices;
  • a post-market surveillance report (PMS report) for class I medical devices.

The PMS plan shall address the collection and utilization of available information, in particular: 

  • serious incidents, including information from PSURs, and field safety corrective actions; 
  • 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.

The post-market surveillance plan shall cover at least:

  • a proactive and systematic process to collect any information listed above. 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; 
  • 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;
  • reference to procedures to fulfil the manufacturers obligations in the field of post-market surveillance;
  • 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 post-market clinical follow-up (PMCF plan), or a justification as to why a PMCF is not applicable. 

(Rif. Annex III MDR)

To sum up, in the PMS plan, the manufacturer defines the processes, procedures, methods and tools through which to collect and evaluate market-derived data on its medical device. Depending on the 'activity considered, the PMS can be divided into passive PMS and active PMS.

Passive PMS consists of evaluating feedback information from the market, then appropriately handling incoming reports of complaints, incidents, adverse events of particular severity, appropriately notifying the relevant authorities, and taking subsequent preventive and corrective actions (vigilance activities).
Active PMS involves the manufacturer's actively conducted search in the market for information about its device, through activities such as monitoring of safety alerts, relevant databases and/or registries, evaluation of scientific literature, questionnaires to physicians and/or users, etc.

During the Post-Market Clinical Follow-Up the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market within its intended purpose with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence. The PMCF is required by the MDR, and it shall be understood to be a continuous process that updates the medical device clinical evaluation.
It is clearly stated in the MDR Regulations that the manufacturer shall specify and justify what level of clinical evidence is necessary to demonstrate that the device complies with legal requirements, it follows that even in the case of Post-Market Clinical Follow-up activity it is the manufacturer who determines the means by which it is most appropriate, depending on the characteristics and intended use of the device, to collect clinical data. Examples may be a literature search repeated with appropriate periodicity, a questionnaire to be submitted periodically to users, an analysis of adverse event databases to collect data on one's own device or similar or equivalent devices or a combination of these activities. In other cases, however, patient-based clinical data should be collected by conducting post-market clinical investigations (PMCF studies).

PMCF shall be performed pursuant to a documented method laid down in a PMCF plan.
The PMCF plan shall specify the methods and procedures for proactively collecting and evaluating clinical data with the aim of: 

  • confirming the safety and performance of the device throughout its expected lifetime; 
  • identifying previously unknown side-effects and monitoring the identified side-effects and contraindications; 
  • identifying and analyzing emergent risks on the basis of factual evidence; 
  • ensuring the continued acceptability of the benefit-risk ratio, and  
  • identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct. 

The PMCF plan shall include at least: 

  • the general methods and procedures of the PMCF to be applied, such as gathering of clinical experience gained, feedback from users, screening of scientific literature and of other sources of clinical data; 
  • the specific methods and procedures of PMCF to be applied, such as evaluation of suitable registers or PMCF studies; 
  • a rationale for the appropriateness of the methods and procedures referred to the previous two points;
  • a reference to the relevant parts of the clinical evaluation report and e to the risk management;
  • the specific objectives to be addressed by the PMCF; 
  • an evaluation of the clinical data relating to equivalent or similar devices; 
  • reference to any relevant CS, harmonized standards when used by the manufacturer, and relevant guidance on PMCF; and
  • a detailed and adequately justified time schedule for PMCF activities (e.g. analysis of PMCF data and reporting) to be undertaken by the manufacturer. 

The manufacturer shall analyze the findings of the PMCF and document the results in a PMCF evaluation report (PMCF report). The PMCF report conclusion shall be part of the clinical evaluation report and the technical documentation. (Rif. ANNEX XIV – PART B MDR)
Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (PSUR), a document summarizing the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance, throughout the lifetime of the device concerned.

The 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. 
For class III devices or implantable devices, manufacturers shall submit PSURs to the notified body involved in the conformity assessment. The notified body shall review the report and add its evaluation with details of any action taken. Such PSURs and the notified body evaluation shall be made available to competent authorities. The PSUR submission, together with the related notified body evaluation, will be by means of the electronic system (EUDAMED), when it is fully active and functional. For class IIa and IIb devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities. (Rif. Article 86)

Finally, the PMS report, drawn up by the manufacturers of class I medical devices, summarizing 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. (Rif. Article 85)

The MDR Regulation requirements on post-market surveillance, market surveillance and vigilance are found to be applicable from the date of entry into force of the MDR Regulation (26 May 2020), replacing the corresponding requirements of the "old" Directives, even for legacy devices and throughout the entire transition period.

Please see below a schematic representation summarizing what the post-marketing surveillance system is: