MDCG Surgical Mesh Implants Guidance
The Medical Device Coordination Group (MDCG) has published a new guidance document on Vigilance System for…
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FDA AI Program: AI/ML Medical Device Research
The FDA’s AI Program in the Center for Devices and Radiological Health conducts regulatory science research to…
FDA Announces eMDR System Updates
The FDA has announced updates to the CDRH’s Electronic Medical Device Reporting (eMDR) system. These updates are crucial for…
Swissmedic: Reporting Serious Events for Medical Devices & IVDs
Swissmedic recently unveiled an insightful video that underscores the critical nature of reporting serious…
FDA Drafts Guidance for Dental Bone Grafting Studies
The FDA has provided draft guidance concerning its recommendations related to animal studies used to support premarket notification (510(k)) submissions…
EU Council: New Rules to Prevent Medical Device Shortages
The EU Council has adopted new rules to prevent medical device shortages and…
New Update to the MDCG 2022-4 Guidance Document
The Medical Device Coordination Group (MDCG) has released an update to the MDCG 2022-4 (Rev. 2)…
MHRA International Recognition for Medical Devices
The MHRA has issued a statement describing the draft policy detailing the intention of the UK to proceed with…
MHRA Proposes Common Specifications for High-Risk IVD Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has proposed future amendments to the Medical Devices Regulations 2002 (MDR…
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