EUDAMED Free Training From The European Commission
The European Commission is hosting a free training workshop in Stuttgart to prepare for EUDAMED onboarding.
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New EU Harmonized Standards for the MDR and IVDR
Harmonized standards in the European Union (EU) play a crucial role in ensuring that products, services, and processes comply…
Switzerland to Approve FDA-Certified Medical Devices in 2025
In Q2 2025, the Federal Council will decide how and at what pace it will implement the Müller motion (20.3211),…
ISO 15223-1 Amendment 1:2025 Updates for Medical Devices
As your Global Partner for Medical Device Regulatory Compliance, MedEnvoy would like to notify manufacturers that the…
HPRA Update: Economic Operator Registration Verification
The HPRA (Health Products Regulatory Authority), has posted a regulatory update regarding verification of economic operator registration details…
New COFEPRIS Guidelines for Good Manufacturing Practices
In an effort to streamline processes and strengthen the certification of medical devices in Mexico, the Federal Commission…
Key Changes to Medical Device Registration with MHRA
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has implemented important updates to the registration process for medical devices.
EU MDR & IVDR: Certificates with Conditions to Support Innovation
The EU Medical Device Regulation (MDR) 2017/745 and the In-Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746 provide a mechanism that…
FDA Increases Oversight on Data Integrity for Device Submissions
The U.S. Food and Drug Administration (FDA) is the U.S. government agency responsible for protecting public health by…
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