by Regulatory & More Oct 6, 2020

The Post-Market Surveillance (PMS) Plan under the MDR and the IVDR (Art. 84/79)

PMS Plan: Definition & Purpose

A Post-Market Surveillance (PMS) plan is a document identifying the PMS process activities and their frequencies for collecting PMS inputs.

Everything regarding the design, the planning, and the organisation (action plan) of the PMS activities shall be in this document, and it must provide answers to these questions: Which activities are planned? How these activities will be executed (methods) and based on what (input data)? What are the deliverables (outputs) for each activity? What will be done with these deliverables? Who is doing what by when?

More precisely, the PMS plan must define:

Which stakeholders are involved at which stages?
What are their roles and responsibilities (RACI matrix)?
What are their activities?
Which deliverables and deadlines are associated to these activities?
Which inputs data are used by the stakeholders?
How this input data is evaluated and processed?
How the data evaluation is communicated, and which actions it has to trigger.

A PMS Plan has to be established for each device or device family.

MDR/IVDR Requirements about the PMS Plan

Article 84 MDR and article 79 IVDR mention that the PMS system of a manufacturer shall be based on a PMS plan but both articles don’t mention directly which are the requirements related to it, redirecting the lecturer near their respective Section 1 of Annex III.

For devices other than custom-made devices, the PMS plan shall be part of the technical documentation.

Both articles have almost the same requirements. Minor differences can be highlighted. Same thing for their respective Annex III.

Translated Requirements

Input Sources - Annex III, Section 1, point (a)

For both medical devices and IVDs, the input sources to be included in a PMS plan should be at least the following according to the MDR and IVDR (no main differences between MDR and IVDR – requirements are almost identical):

Information concerning serious incidents:
- Information from Periodic safety update reports (PSURs)
- Information from Field Safety Corrective Actions (FSCAs)
Records referring to non-serious incidents and data on any undesirable side-effects
Information from trend reporting
Relevant specialist or technical literature, databases and/or registers
Information, including feedbacks and complaints, provided by users, distributors and importers
Publicly available information about similar medical devices.

Evaluation Methods - Annex III, Section 1, point (b)

For both medical devices and IVDs, the evaluation process and methods to be used in a PMS plan should be at least the following according to the MDR and IVDR (no main differences between MDR and IVDR – requirements are almost identical):

Proactive and systematic process to collect any information referred to in point (a).
Process allowing a correct characterisation of the performance of the devices
Process allowing 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 that shall be used in the 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
Methods and protocols to manage the incidents subject to the trend report (incl. increase in the frequency or severity of incidents as well as the observation period)
Methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;
Reference to procedures to fulfil the manufacturers obligations
Systematic procedures to identify and initiate appropriate measures including corrective actions
Effective tools to trace and identify devices for which corrective actions might be necessary
A Post Market Clinical Follow-up (PMCF) plan or a justification as to why a PMCF is not applicable.

Output Reports - Annex III, Section 2

The implementation of the PMS plan can lead to two kind of reports. Both are based on the device class. (no main differences between MDR and IVDR – requirements are almost identical):

The Periodic Safety Update Report (PSUR) for Class lla, llb and lll medical devices under the MDR and Class C and D IVD medical devices under the IVDR.
The Post-Market Surveillance Report (PMSR) for Class I medical devices under the MDR and Class A and B IVD medical devices under the IVDR.

Comparison Table

EU MDR – Regulation (EU) 2017/745

EU IVDR – Regulation (EU) 2017/746

Article 84

Post-market surveillance plan

Article 79

Post-market surveillance plan

The post-market surveillance system referred to in Article 83 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III.

For devices other than custom-made devices, the post-market surveillance plan shall be part of the technical documentation specified in Annex II.

The post-market surveillance system referred to in Article 78 shall be based on a post-market surveillance plan, the requirements for which are set out in Section 1 of Annex III.

The post-market surveillance plan shall be part of the technical documentation specified in Annex II.

ANNEX III

TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 83 to 86 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

1. The post-market surveillance plan drawn up in accordance with Article 84.

The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 83.

(a) The post-market surveillance plan shall address the collection and utilization of available information, in particular:

— information concerning serious incidents, including information from PSURs, and field safety corrective actions;

— records referring to non-serious incidents and data on any undesirable side-effects;

— information from trend reporting;

— relevant specialist or technical literature, databases and/or registers;

— information, including feedbacks and complaints, provided by users, distributors and importers; and

— publicly available information about similar medical devices.

(b) The post-market surveillance plan shall cover at least:

— a proactive and systematic process to collect any information referred to in point (a). The 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 that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;

— effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;

— methods and protocols to manage the incidents subject to the trend report as provided for in Article 88, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;

— methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;

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

— systematic procedures to identify and initiate appropriate measures including corrective actions;

— effective tools to trace and identify devices for which corrective actions might be necessary; and

— a PMCF plan as referred to in Part B of Annex XIV, or a justification as to why a PMCF is not applicable.

2. The PSUR referred to in Article 86 and the post-market surveillance report referred to in Article 85.

TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the manufacturer in accordance with Articles 78 to 81 shall be presented in a clear, organised, readily searchable and unambiguous manner and shall include in particular the elements described in this Annex.

1. The post-market surveillance plan drawn up in accordance with Article 79.

The manufacturer shall prove in a post-market surveillance plan that it complies with the obligation referred to in Article 78.

(a) The post-market surveillance plan shall address the collection and utilisation of available information, in particular:

— information concerning serious incidents, including information from PSURs, and field safety corrective actions,

— records referring to non-serious incidents and data on any undesirable side-effects,

— information from trend reporting,

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

— information, including feedbacks and complaints, provided by users, distributors and importers, and

— publicly-available information about similar medical devices.

(b) The post-market surveillance plan shall cover at least:

— effective and appropriate methods and processes to assess the collected data;

— suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the risk management as referred to in Section 3 of Annex I;

— effective and appropriate methods and tools to investigate complaints and analyse market-related experience collected in the field;

— methods and protocols to manage the incidents subject to the trend report as provided for in Article 83, including the methods and protocols to be used to establish any statistically significant increase in the frequency or severity of incidents as well as the observation period;

— methods and protocols to communicate effectively with competent authorities, notified bodies, economic operators and users;

— reference to procedures to fulfil the manufacturers obligations laid down in Articles 78, 79 and 81;

— systematic procedures to identify and initiate appropriate measures including corrective actions;

— effective tools to trace and identify devices for which corrective actions might be necessary; and

— a PMPF plan as referred to in Part B of Annex XIII, or a justification as to why a PMPF is not applicable.

2. The PSUR referred to in Article 81 and the post-market surveillance report referred to in Article 80.

References

Regulation (EU) 2017/745 MDR: 02017R0745 — EN — 24.04.2020 — 001.001 (consolidated version)

Regulation (EU) 2017/746 IVDR: 02017R0746 — EN — 05.05.2017 — 000.003 (consolidated version)