Post Market Surveillance

Post Market Surveillance for Medical Device

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).

Difference between PMS & Vigilance

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.

PMS Relationship ISO 13485 & ISO 14971

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.

Post Market Surveillance

Common PMS Data Sources recommended by MDR

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

We have developed complete solutions for regulatory compliance.

Readers  contact at for requirements in (a) Ready to use procedures (b) ready to use templets or (c) consulting requirements.

  • To prove the continuing safety of the device
  • To address any adverse effects observed due to the device
  • To list out the corrective and preventive actions taken during the study

Manufacturer has to decide the frequency. Normally yearly once it is recommended.

As per Article 64, PMS referred to in Article 83 shall be based on a PMS plan, for devices other than custom-made devices clearly mentioning the Duration, Frequency, Region & Desired device features.

We understand the product, market, device features and associated risk of the device and draft PMS procedure and Plan and necessery templates.

Analysis data received from multiple sources and if required guide manufacturer to proceed with CAPA or PMCF or if required design change and Hazard analysis.

Consolidate the data and prepare Post-Market Surveillance Report.

PSUR is new as per MDR 2017 Article 86.

Periodic safety update report (PSUR) is made based on the PMS & PMCF resultans.

New MDR PSUR is mandatory and to be submitted to Notified Body on annual basis.

NB-MED/2.12/Rec1 - PMS Guideline.

Procedure to be made as per guideline and MDR article 83, 84 & 85.

INDIA & Bangalore
+ 91 994 591 2081
Phone / WhatsApp

USA & Chicago
+1 630 696 1293
Phone / WhatsApp

GERMANY & Bremen
+49 2161 990 8831
Phone / WhatsApp