VII-Periodic Safety Update Report (Rev 1), Part VII. Structures and processes. Note that submission of a PSUR does not constitute an application to vary the registration. Each report must have been prepared within ninety calendar days of the data lock point for that report. The Development safety Update Report (DSUR) is an annual report, U.S. Investigation New Drug Application (IND) and the EU Safety yearly description is a common standard for periodic reporting on the drug being developedDSUR. Provides data on ed drugs under promotadditional study. The Periodic Safety Update Report must be submitted to the Notified Body or the Competent Authority (upon request) during the conformity assessment and it is a compulsory part of the technical documentation as per article 86 of EU MDR 2017/745. It must also be updated as and when required. PSUR frequency amended and DLP updated on PRAC Representative updated on Next DLP was updated and 'Are PSURs required for products referred to in Article 10(1), 10a, 14, 16a of Directive 2001/83/EC as amended' was amended on Lead MS was added on PSUSA/00003 acebutolol. For products of class IIa and higher, the report is called “Periodic Safety Update Report”, PSUR. The goal of both reports is to provide authorities or the designated office a rapid overview of the post-market activities, in particular about the implementation of the plan, the data collected, the conclusions and actions.
PSUR and PMS report: Regulatory background and objectives
The European Commission has significantly increased the requirements for monitoring products with the directives (MDR, IVDR). According to section 1 in chapter VII of the MDR or IVDR, the manufacturer must establish a surveillance system which is normally part of the quality management system. Corresponding instructions for conduct should be, for example:
- Data that the manufacturer collects after marketing
- Channels to reach the manufacturer via these data
- Methods for analysing the data
- Specifications to decide how to react to the data
- Lists of possible measures (CAPA, reports to authorities, recall, etc.)
- Documentation of this process
The manufacturer must document this surveillance specific to product in a Post-Market Surveillance Plan (MDR article 84, IVDR article 79). The MDR and the IVDR also require the manufacturer to document the results of this surveillance.
For medical devices on class 1, this report is called “Post-Market Surveillance Report”). For products of class IIa and higher, the report is called “Periodic Safety Update Report”, PSUR.
Fda Periodic Safety Update Reports Psurs
The goal of both reports is to provide authorities or the designated office a rapid overview of the post-market activities, in particular about the implementation of the plan, the data collected, the conclusions and actions.