Post Market Surveillance

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 to identify any need to apply any necessary corrective or preventive actions immediately.

• Post Market Surveillance activities should be planned, established, documented, implemented, maintained and updated in proportionate to the risk class and appropriate for the type of device.
• Post Market Surveillance of medical devices should be conducted for the device upon release into the market, irrespective of its CE marking.
• The PMS study for a medical device should be performed if the device is available in the market and continuing sales of the device are observed.
• The data on sales history and the countries in which devices are sold should be thoroughly studied for performing PMS.
• MDR PMS plan must be established as part of the assessment of PMS and should be based on available data and assessment of residual risks.
• The residual risk identified for the device as part of the risk management activities should be considered. The implementation of the Post Market Surveillance system should provide the residual risks observed during the risk management of the device and its control measures taken.
• The residual risk (if applicable) should be considered during the data collection through various PMS sources.

Criteria for Conducting Post Market Surveillance (PMS) Study as per EU 2017/745 and 2017/746

1. The PMS study for a medical device should be performed if the device is available in the market and continuing sales of the device are observed.
2. The data on sales history and the countries in which devices are sold should be thoroughly studied for performing PMS.
3. The detail of sales of the device should be recorded in sales data form.
4. Sales data from domestic and international markets for the device in question.

Output of PMS

1. The Post Market Surveillance study results are considered the input for the other processes like corrective and preventive actions.
2. The output of medical device PMS is the major input for PSUR for class IIa, class IIb and class III devices.
3. Data gathered by the medical device PMS system shall, in particular, be used to update relevant documents in the quality management system.

Updating of Post Market Surveillance Report and PSUR

1. Medical Device PMS report of Class I device shall be updated when necessary and made available to the competent authority upon request.
2. For class IIa, class IIb and class III devices a PMSR is not mandatory, instead, a Periodic Safety Update Report is required.
3. PUSR report is most similar to PMCR, but the documentation requirements slightly differ.

Applicable Standards

• EN ISO 13485: 2016 CL 8.2.1 Customer Feedback
• EN ISO 14971:2012 Risk Management
• NB-MED/2.12/Rec1 Post-Marketing Surveillance (PMS)
• MEDDEV 2.12-1, Rev 8Guidelines on a Medical Device Vigilance System
• MEDDEV 2.12-2, Rev 2 Guidelines on Medical Devices. Post Market Clinical Follow-Up Studies Post Market Clinical Follow-up Studies
• MEDDEV 2.7.1, Rev 4Clinical Evaluation
• MDR 2017/745: Medical Device Regulation of the European Parliament and the Council of 5 April 2017 on medical devices.

PMS Plan

A PMS plan outlines a manufacturer’s approach for constantly monitoring and collecting data and safety information about its equipment. Manufacturers must describe how frequently important documentation is utilized to show GSPR in response to information gathered during the Post Market Surveillance as part of the PMS. A PMS strategy must be presented as part of the CE mark clinical evaluation based on existing clinical data and a risk assessment.