New MDCG Guidance on Investigator’s Brochure for Medical Device Trials
The Medical Device Coordination Group (MDCG) is active this month, releasing a new guidance document. This latest guidance focuses…
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Update on Swissmedic FSCA Report and PRRC Change
Changes to Swissmedic FSCA Report V2.3 Swissmedic has recently updated the Foreign Serious Incident Report (FSCA) template to version 2.3.
EU MDR Compliance Deadline for Legacy Devices is Approaching
By 26 May 2024, manufacturers must have an MDR compliant Quality Management System in place and have lodged an application…
FDA Issues Final Guidance on Sterilization of Medical Devices
The FDA has issued a final guidance on the sterilization of devices labeled as sterile. The guidance updates and clarifies…
FDA Issues Draft Guidance on Cybersecurity for Medical Devices
The Food and Drug Administration (FDA) has released a draft guidance proposing revisions to the “Cybersecurity in Medical Devices:…
UK Government Takes Action to Address Bias in Medical Devices
The Department of Health and Social Care in the UK announced an action plan in response to an independent report…
MDCG Guidance on Clinical Investigation Plans
The Medical Device Coordination Group (MDCG) has published guidance on content for the Clinical Investigation Plans. What are the key…
Updated EU Harmonized Standards List for MDR and IVDR Published
On 6th March, the EU Commission issued two significant decisions, EU 2024/817 and EU 2024/815, focusing on updating the…
EU Commission’s Latest Medical Device Standards Update
On 6th March, the EU Commission published Decision EU 2024/817 and Decision EU 2024/815. These two decisions focused on updating…
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