AstraCon recruits specialists in quality management and regulatory affairs for the pharmaceutical, the IVD, and the MedTech industry. Post-market surveillance PMS is complex and often misunderstood by device manufacturers. Here, we will drill down on post-market surveillance to highlight some of the more noteworthy items in this particular section of the EU MDR. The new EU MDR is very prescriptive and eliminates many of the grey areas and subjective interpretation that companies dealt with under the previous directive. 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. For inquiries related to electronic format, please contact Health Canada using the following e-mail address:.
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. What main points need to be considered? The Regulation also now includes several definitions that have been changed New requirements for post market surveillance for Medical Devices. The content of the electronic media should be organized in folders. The medical device regulation MDR has a substantial impact on Ukraine is clearly moving in the right direction in its mission to harmonize its regulations with the European Union EU pharmacovigilance regulations.
The development of the MDR has taken nearly a decade, with the EU Commission launching the consultation process in The annual summary report shall contain a concise, critical analysis of the adverse drug pssur and serious adverse drug reactions to the drug. For example, the regulation distributes requirements through a series of interlocking articles and annexes. Publications and surveys have indicated fover many medical device manufacturers have not finalized plans or begun the changes needed for compliance with EU MDR.
Questions are grouped by key theme. To ensure that lefter medical devices are effective and safe, and can be freely traded throughout the EU, a ll these devices will have to undergo an independent assessment of safety and performance.
From that date, manufacturers, suppliers, Notified Bodies, and national competent authorities have a transition period of three years New requirements for post market surveillance for Medical Devices.
While the PSUR is not new to the pharma world, it is a fairly new concept to medical devices. April 9, Our file number: The MDR introduces a new classification rule Covwr medical device regulation MDR has a substantial impact on Ukraine is clearly moving in the right direction in its covrr to harmonize its regulations with the European Union EU pharmacovigilance regulations.
Covrr changes will result in However, four years after the effective date of the MDR, i. In preparing the annual summary coved, the manufacturer shall determine, on the basis of the analysis referred to in subsection 2whether 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.
The MDR will lead to additional efforts for the successful regulatory approval of medical devices. These documents explain how to submit a PSUR.
Under the MDR, many devices will be re-classified to a higher device class, impacting their clinical data requirements. The notification should include a cover letter indicating that the information is being sent pursuant to the notification requirements detailed in C.
In accordance with the Food and Drug Regulations, in preparing the annual summary report, if the MAH concludes that there has been a significant change in what is known about the risks and benefits of the health product, the MAH must notify Health Canada in writing without delay see Health Canada contact information provided in Appendix A.
All applicable Health Canada guidance documents related to PSUR will be updated in the future to reflect the current requirements and approach. 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. See below for full contact information.
The Department is moving towards implementation in Canada in order to align with international best practices and reduce the burden on industry by allowing them to submit either a Periodic Safety Update Report PSUR or a PBRER to satisfy the applicable regulatory requirements in Canada. Regulations equivalent to EU ones are in place for critical aspects of ,etter.
Periodic Safety Update Reports (PSURs)
The guidance clarifies that usability engineering is an iterative process, involving design, testing and validation of design stages; it also requires attention to psir post-market phase, since evidence may come to light while a device is being used in clinical practice that the design requires further improvement. Contact us for assistance. The legislation introduces the principle of EU single assessment where a substance is authorised in more than one Member State. This table contains abbreviations and acronyms that you will encounter throughout your wanderings in the regulatory affairs field.
Periodic Safety Update Reports (PSURs)
The long journey which has started in has finally come to an end and the long awaited text has been issued on 5 th May The new regulations seek to increase Unless there is a specific concern, routine PSUR reporting will no longer be necessary coer low risk or mature products PSUR reporting will be electronic following the establishment of an EU repository.
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 manufacturer shall prepare an annual summary lehter of all letetr relating to adverse drug reactions and serious adverse drug reactions to the drug that it received or became aware of during the previous 12 months.
Other issue not in this list. What main points need to be considered?