EMA Launches Pilot Program for Orphan Medical Devices in EU
The European Medicines Agency (EMA) has launched a pilot program aimed at supporting manufacturers of high-risk medical…
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IGJ Report Urges Medical Device Manufacturers to Prioritize PMS
The IGJ, or the National Competent Authority of the Netherlands, published a report as a call to manufacturers to focus…
EU-Swiss Medtech Industry Supports MRA Update Negotiations
A joint statement by Swiss Medtech, SVDI, and MedTech Europe highlights the industry’s support for the ongoing EU-Switzerland negotiations…
RAPS Convergence 2024: MedEnvoy Key Takeaways
From September 17th to 19th, 2024, the MedEnvoy team attended RAPS Convergence 2024. This event brought together regulatory affairs…
EU MDR
EU IVDR
US Agent
General
UK Responsible Person
Egypt Registration Holder
Australian TGA Sponsor
QA Consulting
Swiss Authorized Representative
Global Medical Device Classification Frameworks and Regulations
Medical device classification is the first major step in the regulatory process, whether you’re aiming to sell in the United…
FDA Proposed Reclassification of HBV Diagnostic Devices
On September 25, 2024, the FDA published a proposed change to the classification rules for several…
MHRA Guidance on Clinical Investigations for Medical Devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an updated guidance for notifying clinical investigations involving medical…
Class D IVD Certification: Updated Guidance
The MDCG 2021-4 rev.1 document, updated in September 2024, offers essential guidance on Class D IVD Certification,…
FDA Human Factor in Medical Device Risk Management
Using any type of product in a manner not intended by its manufacturer has the potential to cause harm, a…
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