COVER LETTER PSUR

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 Please refer to Draft Guidance Document: It is possible that a PSUR could be submitted as part of the PSUR Worksharing procedure while at the same time it is also part of an application for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

cover letter psur

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.

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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.

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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

cover letter psur

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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cover letter psur

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.

COVER LETTER PSUR

If the device conforms to the relevant provisions of MDR medical device regulation, the notified body shall issue an EU technical documentation assessment certificate. These documents are regularly updated. In preparing the annual summary report, the manufacturer shall determine, on the basis of the analysis referred to in subsection 2 , whether there has been a significant change in what is known about the risks and benefits of the drug during the period covered by the report and shall include its conclusions in this regard in the summary report. This table contains abbreviations and acronyms that you will encounter throughout your wanderings in the regulatory affairs field. The repository will act as the single point for all submissions including responses and supplementary information. For inquiries related to electronic format, please contact Health Canada using the following e-mail address: Whether the interruption of use or the removal is temporary shall be The requirements on the form, content, frequency of updates of the PSUR and if necessary reviews by a notified body are described in Art.

Currently, the implementation of the recommendations included in the PSUR assessment, e. Some of the specific topics covered include the following: All media should be labelled. PDF versions of documents should be generated from electronic source documents and not from scanned material, except where access to the source electronic file is unavailable or where a signature is required. Regulations equivalent to EU ones are in place for critical aspects of pharmacovigilance. The concept of the PSUR Worksharing project is that all veterinary medicinal products with the same active ingredient or a fixed combination of active ingredients , may maintain the same Data Lock Point for the compilation of PSURs. Good Luck with That!

cover letter psur

Total product lifecycle management is assumed, emphasizing safety backed by clinical data. However, Health Canada suggests that the file names be kept as brief and meaningful as possible.

Periodic Safety Update Reports (PSURs)

The content of the electronic media should be organized in folders. Most significant regulatory change in Europe in over 20 years! Documents of ten pages or more should be bookmarked. This makes it possible for you, as the marketing authorisation holder, to follow the same PSUR submission procedure in all the countries of Europe. Duplicate copies are not required. The time is ticking for the device manufacturers to ensure data, documentations, processes and systems meet requirements. It is the DI assigned at the level of the device unit of use.

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cover letter psur Archives – All About Resume

Post-market surveillance PMS is complex and often misunderstood by device manufacturers. MDR Article 86 Periodic safety update report reads: PSUR’s will help Europe monitor safety trends, alert citizens of risks, and develop common safety standards.

Clinical evaluation and market observation according to MDR. Currently, the implementation of the recommendations included in the PSUR assessment, e. EU medical device regulation: The development of the MDR has taken nearly a decade, with the EU Commission launching the consultation process in Although the new regulations came into force on May 25 th, the date of application for MDR is May 26 th and for IVDR May 26 thwe recommend our North American principals to start the implementation as soon as possible The required submission of Periodic Summary Updates PSUR — combining post-market surveillance, clinical and risk-benefit assessment data — adds to the administrative and cost burden of post-market surveillance for medical device organizations.

Information is outdated or wrong. Share this page Twitter Facebook LinkedIn. They are prepared for each authorised veterinary medicine by the marketing petter holder MAH.

PDF versions of documents should be generated from electronic source documents and not from scanned material, except where access to the source electronic file is unavailable or where a signature is required. The transition periods are not as long as some would have hoped, given the significance of the changes. As the MDR gives particular attention to risk management, we have asked our Medical Device experts to look closely at the new requirements in this field.

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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: Report a problem or mistake on this page.

cover letter psur

Since this is a regulation and not a directive it will be part of the local regulation in all member state Regulatory Affairs Abbreviations and Acronyms List. All enquiries pertaining to this Notice should include the phrase: The EU-MDR enforces reducing risk to patients and creates a way to track each device from the manufacturer to the patient. The following are recommended as good bookmarking legter.

For more information on cookies, see our cookie policy. What main points need to be considered? From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years New requirements for coer market surveillance for Medical Devices.

cover letter psur

The Regulation also now lteter several definitions that have been changed New requirements for post market surveillance for Medical Devices. You will not receive a reply. It is now time for companies to start preparing for the application date of the Regulation in May Gap assessmen t b etw een you r ex istin g d esign d ocu men ts e.

Post-market Surveillance allows for a longitudinal view over time of the safety performance of a medical device or IVD and should allow psr manufacturer to ensure that their The development of the MDR has taken nearly a decade, with the EU Commission launching the consultation process in