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…
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Medical Device Risk Management for Device Manufacturers
Like other types of therapeutic products, risk is…
Understanding TGA Application Audits for ARTG Inclusion
While not all applications for inclusion of a device on the Australian Register of Therapeutic Goods (ARTG) are subject…
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…
Software as a Medical Device (SaMD) EU MDR Compliance
Navigating the realm of Software as a Medical Device (SaMD) within the EU Medical Device Regulation (MDR) can be a…
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…
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…
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