The document is divided into sections identifying the key issues for the development of further guidance. Please refer to Draft Guidance Document: It is possible that a PSUR could be submitted as part of the PSUR Worksharing procedure while at the same time it is also part of an application for re-registration or renewal of a registration. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the product taking into account new or emerging safety information in the context of cumulative information on risk and benefits. The legislation introduces derogation for routine PSUR reporting for certain products. The EU-MDR enforces reducing risk to patients and creates a way to track each device from the manufacturer to the patient. Guidance documents to assist stakeholders in implementing directives related to medical devices.
This is mandatory for both centrally authorised and nationally authorised medicinal products whether they follow the EU single assessment or a purely national assessment procedure. Since this is a regulation and not a directive it will be part of the local regulation in all member states. As a consequence, a variety of interpretations could be observed across the European Union for safety and performance requirements for clinical investigations, reporting requirements during clinical investigations and opinion on the classification of high-risk and borderline products. Good Luck with That! The EU’s Medical Device Regulation is a hot topic in healthcare and a major concern for companies since
As a reminder, the PSUR is not the appropriate procedure for submitting final or interim study reports to the EU regulatory authorities.
A cost-benefit analysis is one of the key decision-making factors in the MDR certification journey. This table contains abbreviations and acronyms that you will encounter throughout your wanderings in the regulatory affairs field. The Minister may, for the purposes of assessing the safety and effectiveness of the drug, request in writing that the manufacturer submit to the Minister one or both of the following: Medical and in vitro diagnostic device manufacturers in the EU are likely aware of big changes in motion.
PSUR Repository and eSubmission Gateway Updated
EU MDR is comprehensive and complex. As the Lerter gives particular attention to risk management, we have asked our Medical Device experts to look closely at the new requirements in this field.
Periodic Safety Update Reports PSURs A Periodic Safety Update Report is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points post-authorisation. The document is divided into sections identifying the key issues for the development of further guidance.
Periodic Safety Update Reports (PSURs)
The MDR has a broader scope than the Medical Device Directives, encompassing, among others, a number of aesthetic devices. According to recent reports believe that they do not have the required understanding of new legislation in-house.
The deadline for EU MDR is fast approaching, and now is the time to take proactive steps to ensure that devices which would improve the lives of patients are not left behind. This rule is especially for software. Guidance documents to assist stakeholders in implementing directives related to lettter devices. About this site Copyright Privacy Cookies Accessibility. Following this short trip to India, we would like to consecrate ourselves to the European PSUR in detail as there are also sufficient abbreviations for potentially causing confusion.
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Periodic Safety Update Reports (PSURs)
ICH requires that the file names be limited to a maximum of 64 characters, including the file extension. What main points need to be considered? The EU’s Medical Device Regulation is a hot topic in healthcare and a major concern for companies since Please refer to Draft Guidance Document: D esi gn D oc um ent Gap A ssessm ent: The Regulation also now includes several definitions that have been changed New requirements for post market surveillance for Medical Devices.
Potential reasons for notification include, but are not limited to, letger significant change in the frequency or severity of a known risk or the identification of a previously unknown risk. Posted by Rob Packard on December 15, Some of the specific topics covered include the following: Good medicines used better.
Publications and surveys have indicated that many medical device manufacturers have not finalized plans or begun the changes needed for compliance with EU MDR. Please follow the procedures outlined in this Notice until such a time as otherwise notified. covee
Although the interpretation of many requirements remain controversial and there are no additional legal acts so far, the transitional period. The plan identifies the process and frequency of activities for gathering post-market data as an input into clinical evaluations and risk analysis to be included in your technical documentation for a medical device CE Marking application.
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The notification should include a cover letter indicating that the information is being sent pursuant to the notification requirements detailed in C. What is a PSUR? Project Manager – Lsur. It should be noted that MAHs are expected to prepare annual summary reports for all their health products with an active Drug Identification Number DINhowever, they need to submit to Health Canada only upon request.