by Regulatory & More Oct 30, 2020

The Periodic Safety Update Report (PSUR) under the MDR and the IVDR (Art. 86/81)

PSUR: Definition & Purpose

The Periodic Safety Update Report (PSUR) is a document summarising the results and conclusions of the analysis of Post-Market Surveillance (PMS) data with usage data.

The purpose of the PSUR is to track the conclusions of the benefit-risk determination, the main findings of the Post-Market Clinical Follow-Up (PMCF) and the volume of sales throughout the lifetime of the device concerned.

MDR/IVDR Requirements about the PSUR

Article 86 MDR and article 81 IVDR mention the requirements for the PSUR. Both articles have almost the same requirements. Minor differences can be highlighted (such as some specific requirements for custom-made devices in the MDR) (See Comparison Table below).

Manufacturers of class IIa, class IIb, class III medical devices and class C, class D IVD medical devices shall prepare a PSUR for each device and where relevant for each category or group of devices.

Content of the PSUR

The PSUR shall present results and conclusion of data gathered from the Post-Market Surveillance plan (PMS plan), and include a rationale and description of corrective action and preventive action (CAPA) taken.

Additionally, throughout the lifetime of the device concerned, the PSUR shall set out:

(a) the conclusions of the benefit-risk determination;

(b) the main findings of the PMCF; and

(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Update of the PSUR

For class IIb, class III medical devices and class C, class D IVD medical devices, the PSUR must be updated at least annually.

For class IIa, the PSUR must be updated at least every two years.

PSUR, Notified Bodies and Competent Authorities

Manufacturers of class III medical devices, implantable medical devices, and class D IVD medical devices shall submit their PSURs electronically via the European Database on Medical Devices (EUDAMED) to their notified bodies.

The notified bodies review the PSURs and add their evaluation to EUDAMED with details of any action taken.

The PSURs and the notified bodies evaluation are also available to the competent authorities through EUDAMED.

Manufacturers of class IIa, class IIb medical devices, non-implantable medical devices and class C IVD medical devices have to make their PSURs available to their notified bodies and, upon request, to the competent authorities.

PSUR and Technical Documentation

The PSUR of class IIa, class IIb and class III medical devices and class C, class D IVD medical devices shall, except in the case of custom-made devices, be part of the technical documentation.

For custom-made devices, the PSUR shall be part of another type of documentation.

Comparison Table

Differences are in orange.

EU MDR – Regulation (EU) 2017/745

EU IVDR – Regulation (EU) 2017/746

Article 86

Periodic safety update report

Article 81

Periodic safety update report

1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 84 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:

(a) the conclusions of the benefit-risk determination;

(b) the main findings of the PMCF; and

(c) the volume of sales of the device and an estimate evaluation of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Manufacturers of class IIb and class III devices shall update the PSUR at least annually. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

Manufacturers of class IIa devices shall update the PSUR when necessary and at least every two years. That PSUR shall, except in the case of custom-made devices, be part of the technical documentation as specified in Annexes II and III.

For custom-made devices, the PSUR shall be part of the documentation referred to in Section 2 of Annex XIII.

1. Manufacturers of class C and class D devices shall prepare a periodic safety update report (‘PSUR’) for each device and where relevant for each category or group of devices summarising the results and conclusions of the analyses of the post-market surveillance data gathered as a result of the post-market surveillance plan referred to in Article 79 together with a rationale and description of any preventive and corrective actions taken. Throughout the lifetime of the device concerned, that PSUR shall set out:

(a) the conclusions of the benefit-risk determination;

(b) the main findings of the PMPF; and

(c) the volume of sales of the device and an estimate of the size and other characteristics of the population using the device and, where practicable, the usage frequency of the device.

Manufacturers of class C and D devices shall update the PSUR at least annually. That PSUR shall be part of the technical documentation as specified in Annexes II and III.

2. For class III devices or implantable devices, manufacturers shall submit PSURs by means of the electronic system referred to in Article 92 to the notified body involved in the conformity assessment in accordance with Article 52. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSURs and the evaluation by the notified body shall be made available to competent authorities through that electronic system.

2. Manufacturers of class D devices shall submit PSUR by means of the electronic system referred to in Article 87 to the notified body involved in the conformity assessment of such devices in accordance with Article 48. The notified body shall review the report and add its evaluation to that electronic system with details of any action taken. Such PSUR and the evaluation by the notified body shall be made available to competent authorities through that electronic system.

3. For devices other than those referred to in paragraph 2, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

3. For class C devices, manufacturers shall make PSURs available to the notified body involved in the conformity assessment and, upon request, to competent authorities.

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)