MEDICA 2025
Schedule a Meeting at MEDICA 2025 MedEnvoy at MEDICA 2025 MedEnvoy is excited to…
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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 referenced…
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 explore…
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 products…
Expanding into EU Market with MedEnvoy Support
Expanding into the European and UK markets can feel overwhelming, especially with the complex documentation, compliance requirements, and supply chain…
MHRA’s New Fee Structure: What It Means for Manufacturers
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has announced significant changes to its statutory…
Manual on Borderline and Classification Under the IVDR and MDR
The Borderline and Classification Working Group (BCWG) has released Version 4 (September 2025) of the Manual…
MHRA Designated Standards Survey Newly Launched
On September 5th, the UK Medicines and Healthcare products Regulatory Agency (MHRA) launched a designated standards survey to identify which…
CE Marking Support: MedEnvoy Partnership
At MedEnvoy, we take pride in helping innovative companies bring their medical devices to market with confidence, with CE marking…
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