Podcast
Questions and Answers
Trend reports are submitted for the first three years after a device is approved for market.
Trend reports are submitted for the first three years after a device is approved for market.
True
Annual reports are typically submitted for a device after the first three years it is approved for market.
Annual reports are typically submitted for a device after the first three years it is approved for market.
False
Alternative Summary Reporting is similar to Periodic Reporting.
Alternative Summary Reporting is similar to Periodic Reporting.
True
The volume of supplemental reports will increase if more devices are approved for market.
The volume of supplemental reports will increase if more devices are approved for market.
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Periodic Reporting, a type of reporting described in the content, is required when a device is approved for market.
Periodic Reporting, a type of reporting described in the content, is required when a device is approved for market.
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Australia’s Database of Adverse Event Notifications (DAEN) has been publicly available since 2012.
Australia’s Database of Adverse Event Notifications (DAEN) has been publicly available since 2012.
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The US FDA’s Medical Device Reporting database has been available to the public since 2000.
The US FDA’s Medical Device Reporting database has been available to the public since 2000.
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The new MDR in Europe aims to improve access to vigilance information and market surveillance.
The new MDR in Europe aims to improve access to vigilance information and market surveillance.
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Japan and Brazil have publicly available information on incidents only in English.
Japan and Brazil have publicly available information on incidents only in English.
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EUDAMED will provide the same access level to all users in the European Union.
EUDAMED will provide the same access level to all users in the European Union.
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Manufacturers must report serious threats to public health within 72 hours of first knowledge.
Manufacturers must report serious threats to public health within 72 hours of first knowledge.
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A serious adverse event that results in death must be reported within 10 days.
A serious adverse event that results in death must be reported within 10 days.
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Technical complaints regarding health products must always lead to a report, regardless of severity.
Technical complaints regarding health products must always lead to a report, regardless of severity.
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Events involving counterfeit devices must be reported within 30 calendar days.
Events involving counterfeit devices must be reported within 30 calendar days.
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No severe adverse events must be reported within 10 calendar days if there is a potential for serious adverse events.
No severe adverse events must be reported within 10 calendar days if there is a potential for serious adverse events.
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Health product holders must report any technically verified complaint within 30 calendar days under certain conditions.
Health product holders must report any technically verified complaint within 30 calendar days under certain conditions.
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Events related to health products must only be reported if they involve patients.
Events related to health products must only be reported if they involve patients.
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A serious event must be reported even if there are no adverse effects on the health of involved individuals.
A serious event must be reported even if there are no adverse effects on the health of involved individuals.
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The EUDAMED Database is fully operational as of May 2020.
The EUDAMED Database is fully operational as of May 2020.
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All devices must comply with the MDR requirements by May 2024.
All devices must comply with the MDR requirements by May 2024.
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Manufacturers have no obligations to report under the MDR if the EUDAMED database is not operational.
Manufacturers have no obligations to report under the MDR if the EUDAMED database is not operational.
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The Medical Devices Regulation (MDR) was published on 5 May 2017.
The Medical Devices Regulation (MDR) was published on 5 May 2017.
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MDSAP participating countries do not have varying vigilance reporting requirements.
MDSAP participating countries do not have varying vigilance reporting requirements.
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IMDRF aims to improve international safety data trends and early signal detection.
IMDRF aims to improve international safety data trends and early signal detection.
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Manufacturers are only required to comply with local regulations, disregarding international standards.
Manufacturers are only required to comply with local regulations, disregarding international standards.
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Robust complaint and vigilance reporting processes are unnecessary for manufacturers.
Robust complaint and vigilance reporting processes are unnecessary for manufacturers.
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An adverse event is defined as an event that leads to a serious injury or death.
An adverse event is defined as an event that leads to a serious injury or death.
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A near adverse event refers to an occurrence that has certainly caused death.
A near adverse event refers to an occurrence that has certainly caused death.
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Manufacturers must report a serious threat to public health to the Therapeutic Goods Association (TGA) only if they are not the Australian Sponsor.
Manufacturers must report a serious threat to public health to the Therapeutic Goods Association (TGA) only if they are not the Australian Sponsor.
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Regulation (EU) 2017/745 specifically addresses medical devices in Europe.
Regulation (EU) 2017/745 specifically addresses medical devices in Europe.
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A hazard that arises from a systematic failure of a medical device must have been previously known by the manufacturer to be classified as a serious threat.
A hazard that arises from a systematic failure of a medical device must have been previously known by the manufacturer to be classified as a serious threat.
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Serious threats to public health must always lead to medical or surgical intervention.
Serious threats to public health must always lead to medical or surgical intervention.
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The existence of a probable rate of occurrence of harm must be known for a hazard to be considered serious.
The existence of a probable rate of occurrence of harm must be known for a hazard to be considered serious.
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The Council Directives 90/385/EEC and 93/42/EEC were repealed by Regulation (EU) 2017/745.
The Council Directives 90/385/EEC and 93/42/EEC were repealed by Regulation (EU) 2017/745.
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EUDAMED facilitates transparency by providing easy access to information for the public and healthcare professionals.
EUDAMED facilitates transparency by providing easy access to information for the public and healthcare professionals.
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One of the functions of EUDAMED is to manage financial reports related to market surveillance.
One of the functions of EUDAMED is to manage financial reports related to market surveillance.
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The UDI Database in EUDAMED is associated with the registration of economic operators.
The UDI Database in EUDAMED is associated with the registration of economic operators.
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Harmonization of numeric codes for device problems is an initiative required by EUDAMED.
Harmonization of numeric codes for device problems is an initiative required by EUDAMED.
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Article 100 of EUDAMED addresses the registration of economic operators.
Article 100 of EUDAMED addresses the registration of economic operators.
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Periodic summary reports about device safety are included in the EUDAMED system.
Periodic summary reports about device safety are included in the EUDAMED system.
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EUDAMED is only intended for use by European Union member states.
EUDAMED is only intended for use by European Union member states.
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The system on clinical investigations is described in Article 92 of EUDAMED.
The system on clinical investigations is described in Article 92 of EUDAMED.
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EUDAMED involves collaboration between the IMDRF and various countries to improve device-related terms.
EUDAMED involves collaboration between the IMDRF and various countries to improve device-related terms.
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FSCA in EUDAMED stands for Financial Surveillance of Clinical Activities.
FSCA in EUDAMED stands for Financial Surveillance of Clinical Activities.
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Study Notes
Medical Device Vigilance Reporting Requirements
- Medical devices are regulated differently globally, with each country/region having specific requirements for classification, market entry, and post-market requirements.
- Many publications highlight the need to balance safety with timely access to innovative medical devices.
- Medical devices can fail mechanically, electrically, or biologically, leading to serious health issues or death. Reports of these events (vigilance reports) are mandatory.
- The International Medical Device Regulators Forum (IMDRF) works to harmonize medical device regulations globally.
- The Medical Device Single Audit Program (MDSAP) allows conformity assessment for multiple regions during a single audit.
- This document compares vigilance reporting requirements across MDSAP participating countries with the European Medical Device Regulation (MDR).
Vigilance Reporting Across Countries
- Different countries have various requirements for reporting medical device-related incidents.
- The specific countries and regulatory agencies covered vary from the documents.
- Each country has different guidelines and deadlines for reporting incidents, including death, serious injuries, or near misses.
- Some countries require reporting of counterfeit devices.
- The documents detail how different countries collect and report incidents.
- Reporting requirements relate to medical devices.
Complaint Handling and Vigilance Procedure
- Documentation of complaint handling and vigilance reporting procedures is crucial for regulatory compliance.
- Clear definitions of complaints are required for consistent compliance.
- Reporting deadlines should be clearly established
- Complaint forms should include date, device details, event description, and outcome.
- Establish procedures for obtaining device samples post-incident.
- Investigation procedures should be defined to meet reporting deadlines
- Trend analysis is beneficial for identifying and addressing potential issues.
Importance of an Effective Vigilance System
- A robust vigilance system is essential for ensuring patient safety.
- Data from complaints and vigilance reports helps support a device's technical documentation, like clinical evaluation or risk management.
- Reporting data enables ongoing risk assessment and improves device performance.
- Continuous improvement of safety requirements is supported by analysis of data.
- Data analysis helps inform R&D processes for future product development.
Transparency in Vigilance Reporting
- Transparency in medical device safety and performance is becoming increasingly important.
- Online databases allow public access to device-related incidents and corrective actions in multiple countries.
- Publicly available information is a tool for patient and healthcare professionals.
Summary of Requirements
- Tables detail the vigilance requirements, including who reports, what to report, when to report, and how to report it across the mentioned countries
- Differences in reporting requirements are highlighted
- Online databases for different countries are mentioned - some countries have existing publicly available databases, others do not.
- Each countries specific online resources provide specifics about the countries requirements
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Description
Explore the diverse medical device vigilance reporting requirements across various global regions. This quiz delves into topics like safety regulations, post-market reporting, and the harmonization efforts by the IMDRF. Test your knowledge on how different countries compare in their regulations for medical devices.