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On 30^th January 2024 the Medical Device Coordination Group published 5 guidance documents where the MDCG lays down incident reporting guidelines for:

 

• Cardiac Ablation Devices [MDCG 2024 – 1 – 1]
• Coronary Stents and Associated Delivery Systems  [MDCG 2024 – 1 – 2]
• Cardiac Implantable Electronic Devices (CIEDs) [MDCG 2024 – 1 – 3]
• Breast Implants [MDCG 2024 – 1 – 4]

Check out the summary of different guidance documents published under the DSVGs.

 

Guidance on the vigilance system for CE-marked devices - DSVG 00 - Device Specific Vigilance Guidance (DSVG) Template MDCG 2024 - 1 

 

https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1_en.pdf

 

• Purpose: The document is a Device Specific Vigilance Guidance (DSVG) for manufacturers of Specific Devices. It provides guidance on how to report incidents and serious incidents that occurred with Specific Devices to the relevant Competent Authority, in accordance with the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
• Types of reporting: The document outlines three types of reporting:

1. individual serious incident,
2. periodic summary reporting, and
3. trend reporting.

It explains the definitions, criteria, and timelines for each type of reporting, as well as the format and content of the reports.

 

• DSVG examples: The document provides a table with examples of device-related problems that caused or contributed to incidents or serious incidents for Specific Devices. It also indicates which type of reporting should be used for each example, and provides the relevant IMDRF terminologies for categorised adverse event reporting.
• Clinical references and guidelines: The document suggests that manufacturers can use clinical references or current clinical guidelines for Specific Devices to identify incident examples and complications.

 

Guidance on the vigilance system for CE-marked devices - DSVG 01 - Devices for Cardiac Ablation - MDCG  2024-1-1

 

https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-1_en.pdf

 

• It is a device-specific vigilance guidance (DSVG) document that aims to harmonize vigilance reporting and provide guidance for manufacturers of devices for cardiac ablation.
• The document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) of EUMDR, that occurred with devices for cardiac ablation to the relevant Competent Authority.
• It also explains the alternative reporting regimes of periodic summary reporting and trend reporting, as well as the criteria and timeframes for reporting.
• The document provides examples of device-related problems and health effects that should be reported as individual serious incidents, incidents that can be included in periodic summary reports, and post-field safety corrective action serious incidents.
• The document also refers to the clinical references and guidelines for cardiac ablation devices, and the IMDRF terminologies for categorised adverse event reporting.

 

Guidance on the vigilance system for CE-marked devices - DSVG 02 -  Coronary Stents and associated delivery systems MDCG  2024-1-2

 

 https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-2_en.pdf

 

• It is a Device Specific Vigilance Guidance (DSVG) that aims to harmonise vigilance reporting and provide guidance for manufacturers of Coronary Stents and associated delivery systems.
• The document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, that occurred with Coronary Stents and associated delivery systems to the relevant Competent Authority. It explains the criteria, timeframes, and formats for reporting individual serious incidents, periodic summary reports, and trend reports, in accordance with Articles 87 and 88 MDR.
• The document provides a table of examples of device-related problems that caused or contributed to the incidents or serious incidents, and indicates whether they should be reported as individual serious incidents, periodic summary reports, trend reports, or not reported. The examples are based on the IMDRF Terminologies for Categorised Adverse Event Reporting, which are also referenced in the document.
• The document suggests some clinical references or current clinical guidelines for Coronary Stents and associated delivery systems that may be used by manufacturers to identify incident examples and complications.

 

 

Guidance on the vigilance system for CE-marked devices - DSVG 03 - Cardiac Implantable Electronic   Devices (CIEDs) MDCG  2024-1-3 

 

https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-3_en.pdf

 

• It is a device specific vigilance guidance (DSVG) that aims to harmonize vigilance reporting and provide guidance for manufacturers of CIEDs and their leads.
• The document outlines the way to report incidents and serious incidents, defined in Article 2(64) and (65) MDR, that occurred with CIEDs and their leads to the relevant Competent Authority. It also explains the concepts of periodic summary reporting (PSR) and trend reporting, as defined in Article 87 and 88 MDR, and provides examples of what should be reported as device-related problems that caused or contributed to the incidents or serious incidents.
• The document provides a table with examples of clinical/symptomatic and device problems that should be reported as individual serious incidents, included in PSRs, or reported as trends, along with the corresponding IMDRF Annex A and E codes.
• It also refers to the current clinical guidelines for cardiac therapeutic procedures, expert consensus statements and current analysis of complications that can be found on the European Society of Cardiology’s website.
• It advises manufacturers to consult the most recent version of the IMDRF terminologies for categorised adverse event reporting.

Guidance on the vigilance system for CE-marked devices - DSVG 04 - Breast Implants MDCG  2024-1-4

 

https://health.ec.europa.eu/system/files/2024-01/mdcg_2024-1-4_en.pdf

 

• It is a device-specific vigilance guidance (DSVG) for manufacturers of breast implants, providing clarification on how to report incidents and serious incidents to the relevant competent authority in accordance with the Regulation (EU) 2017/745 on medical devices (MDR)
• The document outlines the reporting requirements for different types of events involving breast implants, such as individual serious incidents, periodic summary reports, trend reports, and post-field safety corrective action incidents.
• It also specifies the reporting timelines, formats, and contents for each type of event, as well as the criteria for identifying serious incidents, incidents, and expected undesirable side-effects.
• The document provides a table of examples of device-related problems and clinical signs and symptoms that should be reported as serious incidents or incidents for breast implants, along with the corresponding IMDRF terminologies and codes.
• The table also indicates which events can be included in periodic summary reports or trend reports, and the periodicity of such reports.
• The document advises manufacturers to consult relevant local clinical guidelines and references when identifying incident examples and complications for breast implants.

With all of these inputs, manufacturers need to keep in mind that the European Commission and the regulations have a high focus on patient safety. Through these guidance documents and the introduction of several updates, the commission and its subgroups are making regulatory requirements easy to navigate. Experts at Med-Di-Dia provide further support and ensure a smooth transition and navigation of regulatory requirements.

 

Based on our experience, manufacturers must focus on

 

• Create, Execute, and Maintain robust quality management systems.
• Get the ducks in order by adopting Risk Management plans.
• Maintain ongoing compliance with Post-Market surveillance requirements.

Experts at Med-Di-Dia are here to eliminate Regulatory Barriers by becoming your Risk Partners!

Contact us by sending an email – mdd@mddltd.com  or by filling out this web form - https://mailchi.mp/a3744c8d52c0/eumdr