Post Market Surveillance

Post Market Surveillance for medical devices is a collection of processes and activities EU MDR & US FDA uses to monitor the safety and effectiveness once they are on the market. Post market surveillance system helps in actively and systematically gather, record and analyze relevant data on the quality, performance and safety of a device throughout its entire lifetime. Results of PMS helps continuously update the risk file and takes necessary CAPA controls on time.

To comply with the European Union new Medical Device Regulation manufacturers must conduct PMS as outlined in NEW MDR Article 83. The above regulators insist on Post Market Surveillance to makes every effort to assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once medical devices are widely used by health care providers and patients, new issues occasionally arise. These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance. Clinical outcome facilitates the development of new devices or new uses for existing devices.

Post Market Surveillance Report (PMCR)

All class 1 medical device manufacturers including class Is, Im & Ir are required to summarize the results and conclusions of the data gathered during the conduct of surveillance as per PMS plan. The summery of conclusion of data with description of corrective and preventive action if necessary taken collectively called Post Market Surveillance Report (PMSR).

Vigilance is only one part of the post-market surveillance system, as it refers to the reporting of serious incidents, field safety corrective actions (FSCAs) and recalls. It is a reactive system that deals with incidents, rather than the proactive collection of PMS data.

A : Proactive (Review- Driven) Sources

  • Relevant specialist or technical literature
  • Publicly available information about similar medical devices
  • Surveys and feedback provided by users, distributors and importers
  • Experience with similar devices
  • Clinical Literature review, databases and/or registers
  • Retrieval studies on explants
  • In-house testing
  • Post Market Clinical Follow Up (PMCF)

B : Reactive (Incident – Driven) Sources

  • Detection of manufacturing problems
  • Customer complaints and warranty Claims
  • Information Concerning Serious Incidents, including information from PSUR & Field Safety Corrective Actions
  • Non-serious incidents and data on any undesirable side-effects
  • Information from Trend Reporting
  • Service records
  • Compatibility with other medical devices
  • Device misuse
  • Continuing Market Viability
  • Vigilance
  • Failure analysis

The manufacturer maintains an up-to-date systematic procedure to review experience gained from devices in the post-production phase, which includes provisions referred to EU MDR Chapter VII, Section 1.

Article 83 and implement appropriate necessary corrective action as per harmonized standards EN ISO 13485 and EN ISO 14971:2012. .

ISO 13485 gives an outline of a quality management system (QMS) structure which compels the need for a feedback system specifically to provide early warning of quality problems and for input into corrective and preventive action processes.

ISO 13485 requires a systematic approach detailed in clause 8 which outlines the requirements for feedback (clinical & user). The outputs are considered inputs for risk management.

In addition to the pre-market assessment of risks associated with a new device. EN ISO 14971:2012 specifies requirements for production and post-production information to be considered as part of the overall risk assessment process throughout the life of the device.

ISO 14971 requirements aim to measure probabilities and severity of possible damage are correctly analyzed and estimated to make sure the risks are fully identified and mitigated.

The need for Post Market Surveillance (PMS) arises immediately upon the commercialization of the device.

The Post Market Surveillance Procedure complies with MEDDEV 2.12/1, European Medical Device Regulation MDR 2017/745, (EN) ISO 13485:2016.

New MDR Post Market Surveillance requirements and interacting systems find difficult and hard challenge. To initiate the process develop a new QMS process interaction diagram as above with the help of expert hands.


Post Market Surveillance Plan (PMS)

The manufactures should NOT consider post market surveillance plan for product family, it should consider to have a PMS plan that is specific to Intended use, construction, risk class and site of action and also the possible outcome.

Continuous evaluation and improvement of the process is at the very heart of this change, the MDR introduces more clear and prescriptive measures based on device risk level.

PMS requirements are very similar for both MDR and IVDR and are mentioned in 7th chapter. Chapter 7 points out to specific Annexes describing more in detail the provisions relating to this topic.

Post Market Surveillance Plan

Contents of Post Market Surveillance Plan (PMS)

Annex III, describes what information shall be included and specifies that this post market surveillance Plan shall be part of the device Technical Documentation. The important pointers are the following..

    • Information concerning serious incidents, including information from Periodic Safety Update Reports (PSUR), and Field Safety Corrective Actions (FSCAs)
    • All records related to non-serious incidents and undesirable side-effects if any
    • Important technical literature and or databases
    • Feedbacks and complaints provided by users and those from supply chain
    • Similar Medical Devices information
    • Proactive and systematic process to collect information concerning to device in question.
    • Appropriate methods to assess the collected data
    • Procedure for continuous reassessment of the benefit-risk analysis and of the Risk Management
    • Appropriate methods and tools to investigate complaints and analyze market-related experience collected in the field
    • Procedure to communicate with Competent Authorities, Notified Bodies or any other regulatory bodies
    • Procedure to identify and initiate Corrective Actions

As for the Post-market Surveillance Report, the Periodic Safety Update Report shall present Results and conclusion of data gathered from the Post-market Surveillance Plan, includes rationale and description of CAPA taken.

Post Market Clinical Follow Up

When conducting Post Market Clinical Follow Up, the manufacturer shall proactively collect and evaluate clinical data obtained with the aim of confirming the safety and performance throughout the expected lifetime of the device for ensuring the continued acceptability /suitability of identified risks (residual risk) and of detecting any emerging new risks on the basis of factual evidence collected.

If a Medical Device has gained CE Marking based on clinical evidence from a substantially equivalent and similar device, it is a must to conduct PMCF Plan.

If the manufacturer has provided long-term clinical data on the actual device to demonstrate safety, performance, intended use, and stability, a post-market clinical follow-up study may not be necessary.

This page provides important information to be followed by the Organization for conducting Post-market clinical follow-up studies as per MEDDEV 2.12/2 rev 4 as part of maintaining Notified Body CE Certificate.

A Clinical follow-up study is carried out in cases any residual risks are identified or not clear on long term clinical performance that may impact the benefit/risk ratio.

In order to provide evidence of the long term safety and performance of the device, data received via PMS and PMCF are considered most useful for updating the CER throughout the life cycle.

PMCF is a must where there is very limited clinical data for a legacy device and becomes vital where long term data gaps or unanswered questions related to the usage of the device and certain indications, or novel features of a new device exists.

Post Market Clinical Follow Up Plan (PMCF Plan)

As per the new Medical Device Regulation (EU MDR), the Plan shall be a continuous process that updates the Clinical Evaluation Summary Reports and shall be addressed in the manufacturer’s PMS Plan. A PMCF study plan is executed considering the following points

    • PMCF study plan must be designed with the aim to confirm the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks based on factual evidence.
    • PMCF plan must contain the period of study, plan number, PMCF procedure, date of planning, device information, and also confirm or disprove the acceptability of the previously identified risks, discover new risk and evaluate clinical safety and performance.
    • The PMCF plan should describe the appropriate methodology selected for the study
    • PMCF plan should contain inclusion and exclusion criteria
    • PMCF plan should describe the process of clinical data analysis and interpretation of the results.
    • Data to be collected
    • Special control measures needed to be considered and adopted during the study must be identified in the plan
    • PMCF plan should be filled with the respective details with authorization of the personnel prepared by, reviewed by and approved

A PMCF study Plan will help manufacturers and Notified Bodies in the following manner:

    • Demonstrate, for its intended use, clinical safety and performance of a device through its lifetime and
    • Device’s performance to a broad spectrum of physicians and patients.
    • The Plan should have adequate interim follow-up periods for early detection of problems as well as long-term follow-up.
    • The procedure, plans, and relevant records should be controlled and submitted to NB.

Circumstances under which PMCF study to be initiated

    • Novel medical technology
    • High product-related risk
    • High-risk implant/drug-device combination
    • Pediatric use high-risk devices
    • The worst case use scenario [ Severity/Treatment / hard to reach areas]
    • Unanswered questions of long-term safety and performance

Post Market Clinical Follow up Methodology

The most common methodologies adopted for PMCF studies are the following

    • Extended follow up of patients enrolled in premarket investigations
    • A new clinical investigation
    • A review data derived from the device registry.
  • Review of relevant retrospective data from patients previously exposed to the device

Periodic Safety Update Report 

The Periodic Safety Update Report (PSUR) is essentially an extension of a Post Market Surveillance Report (PMSR) containing information for higher risk devices. PSUR is for devices that are low to high-risk, such as Class IIa, IIb, and III. Post-Market Surveillance provides input to Periodic Safety Reports (Results and conclusions of PMS data, vigilance reporting and current status of these devices on the European Market).

The new Medical Device Regulation (MDR) has greatly expanded the standards for tracking medical devices after they have been released to the market and are being used by consumers or patients. The manufacturer must incorporate and track a surveillance device as part of Harmonized Standard EN ISO 13485:2016, according to MDR/IVDR Chapter VII.

    • Post market data collected.
    • Methods for analyzing the collected data
    • Actions taken to counter the data
    • Actions taken such as CAPA, Vigilance, Recall etc.;
    • Analysis and Conclusion of Data

The above are collected and documented as per PMS Plan mentioned in article 84 and article 79 in MDR & IVDR respectively. MDR / IVDR class 1 device permitted to keep Post Market Surveillance Report (PMSR) and Class 11a, Class 11b & Class 111 products Periodic Safety Update Report (PSUR)

Content of Periodic Safety Update Report (PSUR)

The contents of this report are outlined in Article 86 of the MDR listed below.

    • Summary of the PMS and covering findings of Post Market Clinical Follow Up (PMCF)
    • Data analysis and Conclusions / Result
    • CAPAs taken against actions.
    • Result of Risk Analysis / Residual Risks
    • Sales volume, Geographical Location, User group

Periodic Safety Update Report (PSUR) Timeline

Class 1 PMSR On Request When Necessary
Class 11a PSUR NB Conformity Assessment Review Every 24 months
Class 11b (Non Implant) PSUR NB Conformity Assessment Review 12 months
Class 11b (Implant) PSUR EUDAMAD / NB Conformity Assessment Review 12 months
Class 111 PSUR EUDAMAD / NB Conformity Assessment Review 12 months
IVD Class A,B PMSR On Request When Necessary
IVD Class C PSUR NB Conformity Assessment Review 12 months
IVD Class D PSUR EUDAMAD / NB Conformity Assessment Review 12 months

Role of I3CGlobal in writing and documenting PSUR

    • Development of Procedures and necessary templates.
    • Review of PMS data and conclusion derived by the manufacturer as per PMS plan. Unsatisfied reports; we will provide expert help to solve the issue.
    • Review of PMCF conclusion by the manufacturer. Incase of deficiency we provide expert help to solve the issue.
    • We also help in rewriting PMS and PMCF if required.
    • Review of risk-benefit ratio, residual risk, correlate with PMS and CAPA and design changes.
    • Special emphasis on review of custom made devices.
    • Check details in PSUR against estimate evaluation of the size and other characteristics of the population using the device.
    • Modification in PSUR based on rationale and description of any preventive and corrective actions taken against each risk and CAPA.

PSUR Case Study Presentation

Need help with Periodic Safety Update Report documentation including Data Analysis & Writing. Contact via below email.


(Clinical Evaluation Report Writer, Consulting, Document & CER Writing Services with PMS, PMCF, PSUR)

Worried or confused about MDR Article 61 or MEDDEV 2.7/1 Revision 4 Clinical Evaluation Report?

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Before we send the offer we take you to the cockpit and explain what we do and what you must do in due course.

Class III
Class III
Class III
Class IIb
Class IIb
Class IIb
Class IIa
Class IIa
Class IIa
STAGE 0Development of QMS Clinical Evaluation Processtickticktick
Scoping for Clinical Evaluation tick tick tick
SOP Development for the Clinical Evaluation Activities tick tick tick
Develop Clinical Evaluation Plan tick tick tick
Guidance and Drafting Declaration of Interest tick tick tick
Clinical Evaluator Profile and Selection Support tick tick tick
STAGE 1PHASE 1 – Identification of Pertinent Data
Development of SOP for the Data Retrieval tick tick tick
PHASE 2 – Data Generated and held by Manufacturer *
Development of SOP for the Literature Search & Review tick tick tick
Identify Literature Source and Scientific Literatures tick tick tick
Search Report tick tick tick
STAGE 2Development of SOP for the Demonstration of Equivalencetickticktick
Demonstration for Equivalance Devices tick tick tick
Development of SOP for the Appraisal of Clinical Data tick tick tick
Data Suitability Appraisal tick tick tick
Appraisal of Criteria for Data Contribution tick tick tick
STAGE 3Development of SOP for Analaysis of the Clinical Datatickticktick
Analysis of Clinical Data tick tick tick
STAGE 4Develop Clinical Evaluation Report with Conclusiontickticktick
Review Risk Benefit, IFU / User Manual, Pre-Clinical, Bench Test & Performance Test Data and make appropriate modification if needed tick tick
PMS Guidance & Documentation tick tick
PMCF Guidance and Documentation tick tick
PSUR Guidance & Documentation tick tick
 Cordination, Answering, making corrections in CER Writing and Resubmission to Notified Body till CER Approval.


Important things about CER Writing:

  • Avaliablity of equivalent device 25% fees discount
  • Drug Device combination products 40% additional fees
  • Active Implantable Device 40% additional fees
  • Additional Fess for paid scientific Literatures. The fees may vary between 150-350 USD
  • Complete activities done in cloud. Consultants/Clinical writers travel to client located limited to emergency only.
  • The above fees is for each clinical significance (Clinical Indication) of the medical device.
  • We practice to complete a Class IIb CER writing for a single clinical indication in less than 120 days.


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