All applicable Health Canada guidance documents related to PSUR will be updated in the future to reflect the current requirements and approach. Find out more by exploring the conference agenda. The EU MDR requires significantly larger amounts and different types of both premarket and postmarket device safety and performance data. The MDR will lead to additional efforts for the successful regulatory approval of medical devices. Post-market Surveillance allows for a longitudinal view over time of the safety performance of a medical device or IVD and should allow the manufacturer to ensure that their The development of the MDR has taken nearly a decade, with the EU Commission launching the consultation process in
Please refer to Draft Guidance Document: NSF International hosted an industry forum in the UK on November 30, , to explore the likely impact of the changes on company planning, finance and human resources, particularly in the areas of quality assurance, regulatory and manufacturing functions. EU MDR is comprehensive and complex. Check if your device is a medical device according to MDR. Thank you for your help!
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Periodic Safety Update Reports (PSURs)
Potential reasons for notification include, but are not limited to, a significant change in the frequency or severity of a known risk or the identification of a previously unknown risk. Sections, subsections, tables, figures, and appendices should all be bookmarked.
While the PSUR is not new to the pharma world, it is a fairly new concept to medical devices. The new Regulations on medical and in-vitro diagnostic medical devices Please note that guidance for stakeholders to implement the medical devices regulations is now available on a dedicated page. Nevertheless, after the transition period has expired, all parties involved must meet the new regulatory requirements if they want to market medical devices in the EU, i.
To fulfil the EU MDR time constraint, it is important that associations quicken key basic leadership on issues with long lead times, for example, headcount and staffing, marking, item rollout, cvoer rules, and documentation.
Post-market Surveillance allows for a longitudinal view over time of the safety performance of a medical device or IVD and should allow the manufacturer to ensure that their The development of the MDR has taken nearly a decade, with the EU Commission launching the consultation process in Total product lifecycle management is assumed, emphasizing safety backed by clinical data.
While this also merits the full attention of regulated manufacturers of Medical Devices and also involves significant changes, this Regulation is not in the scope of this white paper.
Periodic Safety Update Reports (PSURs)
By then at the latest, all medical devices marketed in the EU will have to comply with the new regime. If, in preparing the annual summary report, the oetter concludes that there has been a significant change, it shall notify the Minister without delay, in writing, unless this has already been done.
Login error when trying to access an account e. For inquiries related to electronic format, please contact Health Canada using the following e-mail address: Irish Medtech Skillnet in association with Meddev Solutions Limited are delighted to offer a 2-day overview and application of cpver Medical Device Regulation.
Article and Annex references are correct at the time of publication. 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 xover points post-authorisation. The legislation introduces derogation for routine PSUR reporting for certain products.
What is a PSUR?
The following stricter requirements need to be implemented by the end of the transition period in May, in order to market your medical devices futher on: The rule 11 has serious implications: With the exception of the file extension, the file naming convention within each folder is left to the MAH. PDF Version – 47 K.
The long journey which ocver started in has finally come to an end and the long awaited text has been issued on 5 th May Files submitted electronically should neither be zipped nor password protected.
All applicable Health Canada guidance documents related to PSUR will be updated in the future to reflect the current requirements and approach. Here is a map of the EU: Duplicate copies are not required. Clinical evaluation and market observation according to MDR. The deadline for EU MDR is fast approaching, and lether is the time to take proactive steps to ensure that devices which would improve the lives of patients are not left behind.
The naming convention used for the leaf titles is up to the MAH’s discretion; however, meaningful names should be applied. EU MDR is comprehensive and complex. ICH requires that the file names be limited to a maximum of 64 characters, including the file extension.