FDA Regulatory Inspections and Audits
Preparing for regulatory authority (e.g. US FDA) inspections and Notified Body audits (for CE Marking) is a critical, ongoing…
Resources & News
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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 EU AI Act and Notified Bodies
As highlighted earlier this year, Team-NB published an updated version of their Position Paper on “European Artificial Intelligence Act (AI ACT)”, it…
New Team-NB Update on Companion Diagnostics Under the IVDR
Team-NB has released a guidance paper on Companion Diagnostics (CDx), providing clarity on how to interpret significant changes to…
New UK CE Certificate Rules for ARTG Inclusion Applications
The TGA has released the Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025, introducing new…
MEDICA 2025
Schedule a Meeting at MEDICA 2025 MedEnvoy at MEDICA 2025 MedEnvoy is excited…
EU Decision 2025/2078: Harmonized Medical Standards Update
The European Commission published Implementing Decision (EU) 2025/2078, amending Implementing Decision (EU) 2021/1182 by adding the following harmonized standards…
RAPS Convergence 2025 MedEnvoy Key Takeaways
From October 7–9, the MedEnvoy team attended RAPS Convergence 2025 in Pittsburgh, joining global leaders, innovators, and policymakers to…
New MHRA Guidance on Device Registration Fees
Following its earlier announcement of the forthcoming annual device registration fee (effective 1 April 2026), the Medicines and Healthcare…
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