Medical Devices Regulation (MDR) 2017/745 - Postmarket surveillance see more https://www.aretezoe.com/medical-devices

1. Post-Market
Surveillance
Medical Device Regulation 2017/745
Chapter VII, Section 1, Article 83 to 86
ANNEX III
PAGE 1

2. PAGE 2
Annex I
General safety and
performance
requirements
Annex II
Technical
Documentation
Annex III
Technical
Documentation on
Post-market
surveillance
Annex IV
Declaration of
Conformity
Class I (other) Annex V
CE Marking
Class I – sterile, reusable,
measuring function
Annex IX
Quality Management
System, Chapters I, III
Annex XI Part A
Production Quality
Assurance
Class I Devices
Manufacturer only
Annex IV
Declaration of
Conformity
Annex V
CE Marking

3. PAGE 3
Annex I
General safety and
performance
requirements
Annex II
Technical
Documentation
Annex III
Technical
Documentation on
Post-market
surveillance
Annex IX
Quality Management
System,
Chapters I, III
Annex IX
Chapter II
Technical documentation
per device category
Annex XI Part A
Production Quality
Assurance
Annex XI Part B
Production
verification
Class IIa Devices
Annex IV
Declaration of
Conformity
Annex V
CE Marking

4. POST-MARKET
SURVEILLANCE
PAGE 4
• Post-market surveillance system
• Post-market surveillance plan
• Post-market surveillance report
• Periodic safety update report

5. Post-market surveillance plan
PAGE 5
Post-Market
Surveillance Plan
Annex III, Article 1.1
Collection and utilization of available information:
 serious incidents,
 Information from PSURs and FSCAs and trend reporting
 Non-serious incidents, undesirable side-effects
 Relevant technical literature, databases and registers
 Feedbacks and complaints from users, distributors, importers
 Publicly available information about similar medical devices

6. Post-market surveillance plan
PAGE 6
Post-Market
Surveillance Plan
Annex III, Article 1.1
The post-market surveillance plan shall cover at least
 Proactive and systematic process to collect information
 Correct characterization of the performance of the devices
 Allow a comparison between the device and similar products
on the market
 Appropriate methods of data assessment
 Suitable indicators and threshold values for reassessment of
benefit:risk analysis

7. Post-market surveillance plan
PAGE 7
Post-Market
Surveillance Plan
Annex III, Article 1.1
Methods, tools, protocols:
 How to investigate complaints and analyze user experience
 How to manage events subject to trend reports
 How to establish statistical significance of changes in
frequency or severity of incidents
 How to communicate with competent authorities, notified
bodies, economic operators and users
 Procedures to identify and initiate CAPAs
 Tools to trace and identify devices subject to CAPAs
 PMCF plan or why a PMCF is not applicable

8. Post-market surveillance system of the manufacturer
 Based on Post-market surveillance plan
 Integral part of quality management system
 Active and systematic gathering, recording and analyzing relevant data
 Quality, performance and safety of a device
 Each device, entire lifetime
 Suitable to drawing conclusions
 Determine, implement and monitor preventive and corrective actions
PAGE 8
For each device, manufacturers shall plan, establish, document, implement,
maintain and update a post-market surveillance system in a manner that is
proportionate to the risk class and appropriate for the type of device.
Post-Market
Surveillance Plan
Annex III, Article 1.1

9. Updates based on post-market surveillance system
PAGE 9
 Benefit-risk determination and improve risk management
 Design and manufacturing information
 Instructions for use and labelling
 Clinical evaluation
 Summary of safety and clinical performance
 Needs for preventive, corrective or field safety corrective action
 Options to improve the usability, performance and safety
 Contribute to the post-market surveillance of other devices
 Detect and report trends
 Technical documentation
 Serious incidents and FSCAs are reportable (Vigilance, Article 87)

10. Post-market surveillance report
Class I devices
Content
 Summarize the results and conclusions of the analyses
of the post-market surveillance data
 Any preventive and corrective actions taken
 Updated when necessary
 Make available to competent authority upon request.
PAGE 10

11. Periodic safety update report
 Class IIa, IIb, III
 Each device, each category
 Summarize results and conclusions of post-
market surveillance data
 Any preventive and corrective actions taken
 Conclusions of the benefit-risk determination
 Main findings of the PMCF
 Volume of sales of the device
 Estimate of the population treated
 Usage frequency
PAGE 11

12. Periodic safety update report
PAGE 12
 PSUR shall be part of the technical documentation
 Class IIb and class III – annual update
 Class IIa - at least every 2 years
 Class III devices or implantable devices:
Submit report into Electronic system on vigilance and
on post-market surveillance (Article 92) to the notified
body.
Notified body adds its review and evaluation
PSUR and evaluation available to competent authorities
 Other devices:
 PSURs available to NBs and upon request to competent
authorities.