top of page
MHRA guidance on new Medical Devices Post-Market Surveillance requirements
The Medicines and Healthcare products Regulatory Agency (MHRA) has published a suite of guidance to help medical device manufacturers...
Feb 11 min read
New MDCG 2023-4 on Medical Device Software (MDSW) - Hardware combinations: guidance on MDSW intended to work in combination with hardware or hardware components
The Medical Device Coordination Group (MDCG) endorsed a new guidance document, MDCG 2023-4 , on Medical Device Software (MDSW) - Hardware...
Jan 311 min read
Update of MDCG 2022-11 Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements
The Medical Device Coordination Group (MDCG) endorsed MDCG 2022-11 Rev.1 , an update of the position paper with the notice to...
Jan 311 min read
Strategic Planning for 2025: Driving Innovation through Digital Transformation, Sustainability, and Regulatory Alignment in MedTech
2024 has seen the introduction of the EU AI Act and the EU Cyber Resilience Act, the announcement of the UK Regulatory Innovation Office...
Jan 315 min read
bottom of page