New MHRA Outline: Enforcement Activities for UK Compliance
The Medicines and Healthcare products Regulatory Agency (MHRA) issued a new outline containing enforcement activities to ensure compliance with medical…
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New IVD Guidelines: Performance Studies
On May 16, 2024, new guidelines for performance studies involving in vitro diagnostic medical devices (IVDs) were announced by the…
Updated IMDRF Terminologies for Adverse Event Reporting
The overview of International Medical Device Regulators Forum (IMDRF) terminologies for categorized Adverse Event Reporting (AER) (i.e., Medical Device Problem)…
MDCG Guidance: Streamlining Notified Body Processes Under EU MDR and IVDR
The Medical Device Coordination Group (MDCG) has issued four new guidance documents to streamline the processes for Notified Bodies under…
European Authorized Representative Under MDR/IVDR: IGJ Inspection
The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards.
MHRA’s AI Airlock Pilot Project Revolutionizing AI Medical Device Regulation
The MHRA have started a pilot project in response to a white paper published in 2023…
IMDRF Updates Labeling Guidelines for Medical Devices & IVDs
We’re excited to share the latest update to the IMDRF’s labeling guidelines for medical devices and IVDs. The IMDRF/GRRP WG/N52…
MDCG Guidance: Safety Reporting in Performance Studies
There is a new IVDR MDCG guidance published MDCG 2024-4 Safety Reporting in performance studies of in vitro diagnostic medical…
Swiss Medtech Guidance Document for Legacy Devices Compliance
Swiss Medtech released a guidance document tailored for economic operators in Switzerland. It delineates the necessary steps for…
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