New List of Low-Risk and Deregulated Medical Devices in Mexico
On July 7, 2025, an updated Agreement including an updated list of low-risk and deregulated devices in…
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Swissdamed: Device Registration Requirement Updates
Swissmedic has recently expanded its Swissdamed device registration “Questions and answers” section with three new entries…
EU Authorities Urge Medical Device Regulatory Reform
In July 2025, medical device competent authorities from 17 European countries convened in Utrecht to issue a unified…
Medical Device and IVD Registration in Israel
In 2024, Israel reformed its medical device and IVD registration processes for low- and moderate-risk devices to increase the accessibility…
UK Alignment with EU IVD Standards
The UK Government has announced its plans to amend the Medical Devices Regulations 2002 for Great…
New Guidance Timelines for Master UDI-DI Implementation
The Medical Device Coordination Group (MDCG) has published Position Paper MDCG 2025-7, clarifying the timelines for…
FDA Creates New List That Includes Digital Health Technologies
The FDA has updated its lists of medical devices featuring, Digital Health Technologies and more.
UK Medical Device Fee Increase in July 2025
UK Statutory Fee Increase for Device Registrations Effective 16 July 2025 The UK Medicines and Healthcare…
EU Expands eIFU for Medical Devices
On 25 June 2025, the European Commission published Implementing Regulation (EU) 2025/1234, which amends Implementing Regulation…
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