MDR Post market surveillance (PMS)

 MDR PMS Requirements: Article 10(10),83,84,85,86 and Annex III

In MDR, PMS defined as ‘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;

Manufacturer shall set-up, implement and maintain a post-market surveillance system, in accordance with Article 83.

CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE SECTION 1 Post-market surveillance Article 83

- Manufacturer shall plan, establish, document, implement, maintain and update a post-market surveillance system

- It is depending on risk class and appropriate for device type.

- This is part of the manufacturer's quality management system (QMS) referred to in Article 10(9).

- This PMS will actively and systematically be gathering, recording and analysing relevant data (quality, performance and safety) throughout its entire lifetime,

- This helps to draw necessary conclusions and to determine, implement and monitor any preventive and corrective actions.

Uses of PMS gathered data

1.To update the benefit-risk determination, design and manufacturing information, instructions for use, clinical evaluation, summary of safety and clinical performance and to improve the risk management 

2. To identify needs for preventive, corrective or field safety corrective action and options to improve the usability, performance and safety of the device

3. To detect and report trends

4. To contribute to the post-market surveillance of other devices

Article 84 Post-market surveillance plan (PMSP)

 PMS system shall be based on a PMS plan. It shall be part of the technical documentation.

PMS Plan requirements based on Section 1.1 of Annex III.

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

—Serious incidents and field safety corrective actions

—Information from PSURs

—Non-serious incidents and data on any undesirable side-effects

—Trend reporting

— Relevant specialist or technical literature, databases and/or registers

 —Feedbacks and complaints, provided by users, distributors and importers

— Publicly available information about similar medical devices

Post-market surveillance plan shall cover at least:

This process shall allow a correct characterisation 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 can be used to 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; -Trend reporting: To establish any statistically significant increase in the frequency or severity of incidents as well as the observation period - To communicate effectively with competent authorities, notified bodies, economic operators and users - To identify and initiate appropriate measures including corrective actions and effective tools to trace and identify devices for which corrective actions might be necessary

Reference to procedures to fulfil the manufacturers obligations laid down in Articles 83, 84 and 86;

PMCF plan or a justification as to why a PMCF is not applicable.

 

Article 85 Post-market surveillance report (PMSR)

Applicable device: Class I devices

Report content:

1. Results and conclusions of the analyses of the post-market surveillance data

 2.A rationale and description of any preventive and corrective actions taken.

Timelines: The report shall be updated when necessary and made available to the competent authority upon request

Article 86 Periodic safety update report (PSUR)

Applicable device: Class IIa, class IIb and class III devices

Report content:

1. Results and conclusions of the analyses of the post-market surveillance data

 2.A rationale and description of any preventive and corrective actions taken.

(a) Benefit-risk determination conclusions

(b) Main findings of the PMCF

(c) Sales volume and usage frequency (estimate evaluation of the size and other characteristics of the population using the device)

Timelines:

Class IIb and class III devices -annually

Class IIa devices -update when necessary and at least every two years

Class III devices or implantable devices-Manufacturer will submit the PSUR in Electronic system on vigilance and on post-market surveillance. The notified body shall evaluate, and these reports can be made available to competent authority through electronic system.

Click below link to know more about IVDR PMS requirements:https://meddev-info.blogspot.com/2021/04/ivdr-post-market-surveillance.html

References

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC