3 CE Marking Regulatory Challenges and Proven Solutions
Embarking on the process of introducing a new medical device or in vitro diagnostic (IVD) product to the market…
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MDR Transition: Greatest Impacts on Medical Device Manufacturers
Amidst the ongoing evolution of the medical device industry, the MDR transition has become a pivotal focus. The Medical…
eIFU Requirements Under the MDR
The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented…
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FDA Issues Draft Guidance on Cybersecurity for Medical Devices
The Food and Drug Administration (FDA) has released a draft guidance proposing revisions to the “Cybersecurity in Medical Devices:…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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