FDA Guidance on Cuffless Blood Pressure Measuring Devices
The FDA officially released the draft guidance “Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing…
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EU Publishes MDCG Guidance on Post-Market Surveillance
As of December 2025, The Medical Device Coordination Group (MDCG) has published MDCG 2025-10, providing comprehensive guidance on post-market surveillance…
FDA Issues Updated Final eCopy Submission Guidance
The FDA issued an updated final guidance document titled “eCopy Program for Medical Device Submissions” on…
MDCG Master UDI-DI Timelines: Contact Lenses and Spectacles
The Medical Device Coordination Group (MDCG) has published MDCG 2025-7 Rev. 1 (December 2025), a position…
New EU Guidance on Breakthrough Devices & IVDs
In December 2025, the Medical Device Coordination Group (MDCG) published MDCG 2025-9, a new guidance document introducing…
MHRA Expands Regulatory Advice Access for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated and expanded its regulatory advice service for medical devices…
FDA Issues Technical Amendments to Align with QMSR
The U.S. Food and Drug Administration (FDA) has published a final rule implementing technical amendments across…
EU Confirms EUDAMED Functionality and 2026 Deadline
The European Commission has officially confirmed that several key electronic systems within the European Database on Medical Devices (EUDAMED) are…
MDCG 2025-8 and the New Master UDI-DI Requirements
The Medical Device Coordination Group (MDCG) has published MDCG 2025-8, a comprehensive guidance document on the…
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