The MDCG just released their Guidance on Periodic Safety Reports (PUSR) under the MDR. It is available: HERE

The 40-page guidance covers:

Below we have provided an overview of the document; however, the full guidance should be consulted when drafting your PSUR.

What is the purpose of a PSUR?

A PSUR is a stand-alone document created as part of a manufacturer’s post-market surveillance system. The purpose is for manufacturers to analyze post-market surveillance data collected on the device and reevaluate the benefit-risk profile. The manufacturer will complete a summary of the results and analyze them to identify any potential safety and performance concerns.

If there is evidence of an adverse change to the benefit-risk profile, then the manufacturer should evaluate further if the device remains safe and effective.

The PSUR may also be the tool to provide information about Corrective Action(s) or Preventive Action(s) (CAPA), per MDR Article 83(4), first sentence.

“If, in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body”

Which devices require a PSUR?

“Old devices” do not require a PSUR. “Old devices” are those which were placed on the market before 26 May 2021 in accordance with the MDD/AIMDD, and were not placed on the market after this date.  

Legislation	Classification	Required: Yes/No	By When?	How often should it be updated?	Uploaded to EUDAMED?
MDR	Custom-made Class I	No	n/a	n/a	n/a
MDR	Custom-made, Class IIa	Yes	Within two years after the first Statement of Conformity	At least once every two years	No
MDR	Custom-made, Class IIb and III	Yes	Within one year after the first Statement of Conformity	At least once every year	No.
MDR	Class I	No	n/a	n/a	n/a
MDR	Class IIa non-implantable	Yes	Within two years of being newly CE Marked	At least once every two years	No. Manufacturer to make PSUR available to notified body or competent authority upon request.
MDR	Class IIa implantable	Yes	Within two years of being newly CE Marked	At least once every two years	Yes. Manufacturer uploads PSUR to EUDAMED without undue delay. Notified body to add its evaluation to EUDAMED.
MDR	Class IIb non-implantable	Yes	Within one year of being newly CE Marked	At least once every year	No. Manufacturer to make PSUR available to notified body or competent authority upon request.
MDR	Class IIb implantable	Yes	Within one year of being newly CE Marked	At least once every year	Yes. Manufacturer uploads PSUR to EUDAMED without undue delay. Notified body to add its evaluation to EUDAMED.
MDR	Class III (implantable & non-implantable)	Yes	Within one year of being newly CE Marked	At least once every year	Yes. Manufacturer uploads PSUR to EUDAMED without undue delay. Notified body to add its evaluation to EUDAMED.
MDD	Class I	No	n/a	n/a	n/a
MDD	Class IIa (implantable & non-implantable)	Yes	Within two years of the MDR date of application -26 May 2021	At least once every two years	No. Manufacturer to make PSUR available to notified body or competent authority upon request.
MDD	Class IIb (implantable & non-implantable)	Yes	Within one year of the MDR date of application -26 May 2021	At least once every year	No. Manufacturer to make PSUR available to notified body or competent authority upon request.
MDD	Class III (implantable & non-implantable)	Yes	Within one year of the MDR date of application -26 May 2021	At least once every year	No. Manufacturer to make PSUR available to notified body or competent authority upon request.
AIMDD	AIMD	Yes	Within one year of the MDR date of application -26 May 2021	At least once every year	No. Manufacturer to make PSUR available to notified body or competent authority upon request.

What is the duration of the PSUR requirement?

A PSUR is not required for initial certification. It is only required after the device has been CE Marked. Or, for custom-made devices, after the first Statement of Conformity for the device is issued.

The PSUR requirement continues through the lifetime of the device. The lifetime of a device is the time period specified by the manufacturer in the device documentation during which the device is expected to remain safe and effective for use/in use.

The obligation ends only when the last manufactured device of that device model has been placed on the market and the intended lifetime of that device has been achieved. This is true even if the CE Marking certificate has expired but the device’s lifetime is still ongoing. In this situation the PSUR should at least include reactive data regarding product complaints, reporting of serious incidents, FSCA, and trend reports and relevant data from literature research and relevant databases.

MDCG 2022-21 provides example scenarios in case a manufacturer is unclear when their PSUR obligation ends.

Can multiple devices be bundled into a single PSUR?

A PSUR can include a category or group of devices, which may include multiple Basic UDI-DIs / device families. Where a manufacturer does so, they should:

What should be included in the PSUR?

The PSUR should summarize the results and conclusions generated from post-market surveillance activities. If a manufacturer decides that certain datasets are not required for input into the report, they should provide a justification for their exclusion.

The PSUR should also include any actions taken, where appropriate.

The MDCG document also recommends adding an executive summary for the main information related to the benefits and risks, and to any changes to the benefit-risk profile.

Specifically, the PSUR should provide:

Is there a PSUR template available?

MDCG 2022-21 provides a template starting on page 21:

These templates are provided in MDCG 2022-21 in PDF format. Unfortunately, this means that each manufacturer must recreate the Annexes if they want to make use of them.

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How to provide PSURs until EUDAMED is functional?

The PSUR for MDR CE Marked Class IIa implantable, Class IIb implantable, and Class III devices must be uploaded into EUDAMED. However, EUDAMED is not expected to be fully functional until Q2 2024.

Until then, manufacturers deliver the PSURs to their Notified Body in the manner requested, e.g., emailed or uploaded to a document storage system.  

MDD/AIMDD legacy devices, MDR Class IIa and MDR Class IIb non-implantable devices are exempt from uploading their PSURs into EUDAMED. Instead, they must make their PSURs available to Notified Bodies and Competent Authorities upon request, such as to their Notified Body during surveillance audits.