Medical Device Vigilance Reporting Requirements
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Questions and Answers

Trend reports are submitted for the first three years after a device is approved for market.

True (A)

Annual reports are typically submitted for a device after the first three years it is approved for market.

False (B)

Alternative Summary Reporting is similar to Periodic Reporting.

True (A)

The volume of supplemental reports will increase if more devices are approved for market.

<p>False (B)</p> Signup and view all the answers

Periodic Reporting, a type of reporting described in the content, is required when a device is approved for market.

<p>True (A)</p> Signup and view all the answers

Australia’s Database of Adverse Event Notifications (DAEN) has been publicly available since 2012.

<p>True (A)</p> Signup and view all the answers

The US FDA’s Medical Device Reporting database has been available to the public since 2000.

<p>False (B)</p> Signup and view all the answers

The new MDR in Europe aims to improve access to vigilance information and market surveillance.

<p>True (A)</p> Signup and view all the answers

Japan and Brazil have publicly available information on incidents only in English.

<p>False (B)</p> Signup and view all the answers

EUDAMED will provide the same access level to all users in the European Union.

<p>False (B)</p> Signup and view all the answers

Manufacturers must report serious threats to public health within 72 hours of first knowledge.

<p>True (A)</p> Signup and view all the answers

A serious adverse event that results in death must be reported within 10 days.

<p>False (B)</p> Signup and view all the answers

Technical complaints regarding health products must always lead to a report, regardless of severity.

<p>False (B)</p> Signup and view all the answers

Events involving counterfeit devices must be reported within 30 calendar days.

<p>False (B)</p> Signup and view all the answers

No severe adverse events must be reported within 10 calendar days if there is a potential for serious adverse events.

<p>True (A)</p> Signup and view all the answers

Health product holders must report any technically verified complaint within 30 calendar days under certain conditions.

<p>True (A)</p> Signup and view all the answers

Events related to health products must only be reported if they involve patients.

<p>False (B)</p> Signup and view all the answers

A serious event must be reported even if there are no adverse effects on the health of involved individuals.

<p>False (B)</p> Signup and view all the answers

The EUDAMED Database is fully operational as of May 2020.

<p>False (B)</p> Signup and view all the answers

All devices must comply with the MDR requirements by May 2024.

<p>True (A)</p> Signup and view all the answers

Manufacturers have no obligations to report under the MDR if the EUDAMED database is not operational.

<p>False (B)</p> Signup and view all the answers

The Medical Devices Regulation (MDR) was published on 5 May 2017.

<p>True (A)</p> Signup and view all the answers

MDSAP participating countries do not have varying vigilance reporting requirements.

<p>False (B)</p> Signup and view all the answers

IMDRF aims to improve international safety data trends and early signal detection.

<p>True (A)</p> Signup and view all the answers

Manufacturers are only required to comply with local regulations, disregarding international standards.

<p>False (B)</p> Signup and view all the answers

Robust complaint and vigilance reporting processes are unnecessary for manufacturers.

<p>False (B)</p> Signup and view all the answers

An adverse event is defined as an event that leads to a serious injury or death.

<p>True (A)</p> Signup and view all the answers

A near adverse event refers to an occurrence that has certainly caused death.

<p>False (B)</p> Signup and view all the answers

Manufacturers must report a serious threat to public health to the Therapeutic Goods Association (TGA) only if they are not the Australian Sponsor.

<p>False (B)</p> Signup and view all the answers

Regulation (EU) 2017/745 specifically addresses medical devices in Europe.

<p>True (A)</p> Signup and view all the answers

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.

<p>False (B)</p> Signup and view all the answers

Serious threats to public health must always lead to medical or surgical intervention.

<p>False (B)</p> Signup and view all the answers

The existence of a probable rate of occurrence of harm must be known for a hazard to be considered serious.

<p>False (B)</p> Signup and view all the answers

The Council Directives 90/385/EEC and 93/42/EEC were repealed by Regulation (EU) 2017/745.

<p>True (A)</p> Signup and view all the answers

EUDAMED facilitates transparency by providing easy access to information for the public and healthcare professionals.

<p>True (A)</p> Signup and view all the answers

One of the functions of EUDAMED is to manage financial reports related to market surveillance.

<p>False (B)</p> Signup and view all the answers

The UDI Database in EUDAMED is associated with the registration of economic operators.

<p>False (B)</p> Signup and view all the answers

Harmonization of numeric codes for device problems is an initiative required by EUDAMED.

<p>True (A)</p> Signup and view all the answers

Article 100 of EUDAMED addresses the registration of economic operators.

<p>False (B)</p> Signup and view all the answers

Periodic summary reports about device safety are included in the EUDAMED system.

<p>True (A)</p> Signup and view all the answers

EUDAMED is only intended for use by European Union member states.

<p>False (B)</p> Signup and view all the answers

The system on clinical investigations is described in Article 92 of EUDAMED.

<p>False (B)</p> Signup and view all the answers

EUDAMED involves collaboration between the IMDRF and various countries to improve device-related terms.

<p>True (A)</p> Signup and view all the answers

FSCA in EUDAMED stands for Financial Surveillance of Clinical Activities.

<p>False (B)</p> Signup and view all the answers

Flashcards

Annual Reports

Reports submitted annually for the first 3 years a device is approved for market.

Trend or Periodic Reporting

Reports submitted periodically throughout a device's lifespan, usually for specific events or issues.

Alternative Summary Reporting

A summary report that provides an overview of the device's performance and safety.

Periodic Summary Reporting (ASR)

A detailed report describing any unexpected or concerning issues with a device.

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Trend or Periodic Reporting reduces supplemental reports

A type of reporting that reduces the frequency of supplemental reports by providing a comprehensive overview of device performance and safety.

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Australian Database of Adverse Event Notifications (DAEN)

A publicly available database containing adverse event reports for medical devices in Australia, searchable by manufacturer, device name, and other criteria.

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Manufacturer and User Facility Device Experience (MAUDE) Database

A publicly accessible US database, launched in 1996, that allows users to search for adverse events related to medical devices, including manufacturer, device name, event type and product problems.

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Medical Device Regulation (MDR)

The newest regulation in Europe designed to improve transparency and access to information on medical device safety and surveillance records.

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European Database on Medical Devices (EUDAMED)

The European database for medical devices, created under the MDR, designed to improve information sharing and transparency.

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International Organization for Standardization (ISO)

The international organization responsible for developing standards, including standards for medical device coding systems, such as ISO/TS 19218-1:2011.

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Serious threat to public health (medical device)

An event or occurrence related to a medical device that poses a significant risk to public health.

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Systematic failure (medical device)

A systematic failure of a medical device that could lead to serious harm.

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Adverse event (medical device)

An event that resulted in a death, serious injury, or significant deterioration in a patient or user's health.

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Near adverse event (medical device)

An event that could have resulted in a death or serious injury if it hadn't been prevented.

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Medical device safety reports

Reports that manufacturers must submit to regulatory agencies about serious threats to public health, adverse events, and near adverse events related to medical devices.

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Therapeutic Goods Association (TGA)

The organization responsible for regulating medical devices in Australia.

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Australian Sponsor

The individual or company responsible for ensuring a medical device meets regulatory requirements in the Australian market.

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Medical device risk management

The process of identifying, evaluating, and mitigating risks associated with medical devices to ensure their safety and effectiveness.

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What is the MDR?

The Medical Devices Regulation (MDR) is a set of rules for medical devices in the European Union (EU) and European Economic Area (EEA). It was published in 2017 and started working in 2017.

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What does the MDR require manufacturers to do?

The MDR requires manufacturers to report incidents related to medical devices, such as adverse events (harm to patients) or device malfunctions.

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What is the main goal of the MDR?

The MDR aims to improve patient safety by gathering information about medical devices. This data helps identify potential issues early and take action.

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What database is used to support the MDR?

A database called EUDAMED is used to collect information required by the MDR. Manufacturers must report information through this database.

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What is the transition period in the MDR?

The MDR has a transition period, meaning some older devices may be subject to its requirements for a while. But all new devices must follow the MDR after the transition period ends.

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What is the IMDRF?

The International Medical Device Regulators Forum (IMDRF) is an organization that aims to harmonize medical device regulations worldwide.

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Why is the IMDRF important for patient safety?

The IMDRF helps share safety data between countries, which allows for early detection of potential issues with medical devices.

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How do the MDR and IMDRF work together for safer medical devices?

The MDR and IMDRF both contribute to improved patient safety through better monitoring and reporting of medical device issues.

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What is EUDAMED?

A centralized, digital system designed to manage medical device information within the European Union (EU). It aims to improve transparency, safety, and vigilance.

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What is one primary goal of EUDAMED?

A key objective of EUDAMED is to enhance transparency by providing easily accessible information on medical devices to both the public and healthcare professionals.

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What are some components of EUDAMED?

EUDAMED includes a range of modules encompassing registration, certificates, clinical investigations, vigilance, and market surveillance.

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How does EUDAMED contribute to safety?

EUDAMED plays a role in monitoring serious incidents, adverse events, and device non-compliance. This helps ensure the safety of medical devices.

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How does EUDAMED support medical device registration?

EUDAMED assists in managing and tracking medical device registrations within the EU, ensuring compliance with regulations.

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What role does EUDAMED play in sharing device information?

EUDAMED facilitates the collection and sharing of information about medical device performance and safety.

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What is the significance of UDI in EUDAMED?

UDI (Unique Device Identification) plays a key role in EUDAMED, enabling the accurate identification and tracking of medical devices throughout their life cycle.

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How does EUDAMED work towards international harmonization?

EUDAMED aims to improve global harmonization of medical device data by collaborating with international partners.

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How are serious incidents and adverse events managed through EUDAMED?

EUDAMED helps manage the reporting of serious incidents, non-compliance, and adverse events related to medical devices.

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What role does EUDAMED play in continuous improvement of device safety?

EUDAMED assists in collecting and summarizing data on device performance, contributing to ongoing vigilance and continuous improvement of medical device safety.

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What is ANVISA?

The Brazilian health authority responsible for regulating medical devices.

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What is the SNVS?

The national system for monitoring and managing medical device safety in Brazil.

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What are "serious threats to public health" in medical device reporting?

Events that involve a serious health threat.

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What are "death" events in medical device reporting?

Events that result in a patient's death due to a medical device.

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What are "serious adverse events that have not evolved to death" in medical device reporting?

Events that cause serious harm to a patient, but without resulting in death.

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What are "technical complaints with the potential to cause death or serious adverse event" in medical device reporting?

Events that involve a medical device malfunction that could potentially lead to death or serious harm.

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What are "technical complaints with the potential to cause no severe adverse event" in medical device reporting?

Events that involve a medical device malfunction that could potentially lead to non-serious harm.

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What are "fake (Counterfeit device)" events in medical device reporting?

Counterfeit or fake medical devices.

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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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Related Documents

Medical Device Vigilance Reporting Requirements PDF

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.

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