Post Market Surveillance (PMS)

Post Market Surveillance


To comply with the European Union new (Medical Device Regulation MDR) manufacturers must conduct PMS as outlined in NEW MDR Article 83

The above regulators insist for 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.

Post Market Surveillance is a collection of processes and activities EU MDR & US FDA uses to monitor the safety and effectiveness of medical devices once they are on the market.

These activities are designed to generate information to quickly identify poorly performing devices and other safety problems, accurately characterize real-world device performance and clinical outcomes, and facilitate the development of new devices, or new uses for existing devices.

Post Market Surveillance for Medical Device

The manufacturer maintains an up-to-date systematic procedure to review experience gained from devices in the post-production phase, which include 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.

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.

The need for PMS arises immediately upon commercialization of the device.

The source of Post market surveillance is divided into 2 categories

  • (a) Proactive (b) Reactive

A: PROACTIVE

  • expert users groups (“focus groups“)
  • post CE Mark clinical trials
  • and post market clinical follow-up studies (PMCF)

B: REACTIVE

  • complaint monitoring,
  • User feedback or from sales representatives,
  • reports from regulatory authorities,
  • In-house stability studies of sold devices
  • literature reviews,
  • service/repair information
  • user reactions during training programs
  • other bodies (e.g. the CA)
  • the media
  • warranty claims

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  • 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 teh 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.



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