![MDGC Summary of Safety and Performance Template: Section 2](https://www.regdesk.co/wp-content/uploads/2024/06/MDCG-on-SSP-Section-2.jpg)
Jun 7, 2024
EU
The new article describes in detail the second section of the document addressing mostly the matters related to the risks associated with a medical device and information to be provided in this respect.
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![MDCG Guidance on Safety Reporting in IVD Performance Studies: Specific Aspects](https://www.regdesk.co/wp-content/uploads/2024/06/MDCG-on-IVD-performance-studies-specific-aspects.jpg)
Jun 7, 2024
EU
The new article describes in detail specific aspects related to the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
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![MDCG Guidance on Safety Reporting in IVD Performance Studies: Reporting Basics](https://www.regdesk.co/wp-content/uploads/2024/06/MDCG-on-IVD-performance-studies-reporting-basics.jpg)
Jun 7, 2024
EU
The new article provides an in-depth overview of the reporting requirements associated with performance studies involving in vitro diagnostic medical devices.
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![MDCG Guidance on Safety Reporting in IVD Performance Studies: Overview](https://www.regdesk.co/wp-content/uploads/2024/06/MDCG-on-IVD-performance-studies-overview.jpg)
Jun 7, 2024
EU
The article highlights the key points related to the regulatory framework for reporting requirements in the context of certain studies medical devices are subject to.
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![FDA Draft Guidance on Animal Studies for Dental Bone Grafting Material Devices: Data Collection](https://www.regdesk.co/wp-content/uploads/2024/06/FDA-draft-on-animal-studies-data-collection.jpg)
Jun 7, 2024
FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
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![FDA Draft Guidance on Animal Studies for Dental Bone Grafting Material Devices: Study Design](https://www.regdesk.co/wp-content/uploads/2024/06/FDA-draft-on-animal-studies-study-design.jpg)
Jun 7, 2024
FDA
The new article provides additional recommendations to be taken into consideration when preparing the submission, in particular with respect to study design and execution.
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