UK Alignment with EU IVD Standards
The UK Government has announced its plans to amend the Medical Devices Regulations 2002 for Great…
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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…
FDA UDI Requirements for Combination Products
The U.S. FDA has released a draft guidance on FDA UDI Requirements clarifying how UDI requirements…
Medical Device Regulatory Frameworks: New Zealand vs. Australia
To better understand how the medical device frameworks of Australia and New Zealand function in practice, it is essential to…
FDA Cybersecurity Guidance for Medical Devices
The U.S. Food and Drug Administration (FDA) has issued updated guidance titled “Cybersecurity in Medical Devices:…
COFEPRIS Enhances International Product Recognition
The Mexican authority, COFEPRIS, has expanded its international recognition by now accepting regulatory decisions from trusted global authorities (e.g., FDA,…
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