Module 16 2024

10/17/2024

Article 86 – Periodic Safety Update Report (PSUR) – Best Practice?

The aim of the PSUR, as stated in MDCG 2022-21, is to provide a general overview • of the PMS activities , • the collected data and their analysis • along with a summary of all results and conclusions. When preparing the PSUR, it is very important to make a statement regarding the data validity in order to openly address limitations . Conclusions must be stated concerning about new (or emerging) risks or benefits and potential negative impacts on the benefit-risk assessment (see Annex I of MDCG 2022-21). The PMCF conclusions are an essential contribution to the ongoing confirmation of an acceptable benefit-risk profile , and emphasize the importance of properly integrating PMCF into PMS .

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

39

39

Overview of MDR PMS Reporting Requirements

Medical Device Class

Type of Report

Update Frequency

Available to Notified Body

Class I

PMS Report

As necessary

As necessary but at least every second year

Class IIa

PSUR

Yes

Class IIb & III Class Ill and implantable devices

PSUR

Yes

As necessary but at least annually

PSUR

Uploaded to EUDAMED for Notified Body assessment

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

40

40

20