Periodic Safety Update Reports (PSURs) are an important element of the EU’s Regulation 2017/745 on medical devices (MDR). A recently issued comprehensive guidance document, MDCG 2022-21, aims at helping manufacturers to understand these requirements.
It contains five main sections and comes with numerous subsections and five annexes, including a template for the PSUR, and a web form:
- General considerations
- Scope and duration of the PSUR requirement
- Grouping of devices
- PSUR preparation and issuance
MDR’s article 86 obliges manufacturers of class III, class IIb and class IIa devices to prepare a PSUR for each device and where applicable, for each category or group of devices.
PSURs must be prepared for:
|MDR compliant devices|
|Class IIa, class IIb and class III devices certified in line with the requirements of the MDR placed on the market or put into operation before or after the 26 May 2021 MDR date of application|
|Custom-made devices falling within class IIa, class IIb and class III in agreement with the requirements of the MDR|
|Annex XVI devices falling within class IIa, class IIb and class III devices, once the MDR becomes applicable to those devices|
|All legacy devices|
Class I MDR devices, class I legacy devices and old devices (devices for which no individual devices have been placed on the market since 26 May 2021) are not compelled to meet the requirements.
The guidance further explains that the chief aim of a PSUR is to give a summary of the results and deductions of the analysis of post-market surveillance (PMS) data relating to a device or a device group. This facilitates reporting on any possible changes to the benefit-risk profile of the medical device(s), considering new or emerging information in the context of cumulative information on benefits and risks.
The PSUR should sum up the results and deductions of the analysis of the data which the manufacturer has methodically and actively collected in PMS with its device(s) and, where appropriate, with similar devices.
Confusion seemingly remains around the topic of the device lifetime and calls have been heard for a clear, organised presentation instead of a such a lengthy guidance for an already comprehensive and extensive regulation.
Source: Medtech Insight (an Informa product), MDCG