IVDR PMS Requirements: Article 10(9),78,79,80,81 and Annex III
In IVDR, 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 78.
CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND
MARKET SURVEILLANCE SECTION 1 Post-market surveillance Article 78
- 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(8).
- 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, performance evaluation,
summary of safety and 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 79 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; |
|
PMPF plan or a
justification as to why a PMPF is not applicable. |
Article 80 Post-market surveillance report (PMSR)
Applicable device: Class A & B 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 81 Periodic safety update report (PSUR)
Applicable device: Class C & D 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 C & D devices -annually
Class D 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.
Class C devices- Manufacturers shall
make PSURs available to the notified body involved in the conformity assessment
and, upon request, to competent authorities .
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