EC Regulation 2023/2197: UDI Assignment for Contact Lenses
The EC has decided to amend the MDR with regards to the assignment of Unique Device Identifiers (UDI) for Contact…
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RAPS Convergence Montreal 2023: MedEnvoy Key Takeaways
The MedEnvoy team was present at RAPS Convergence which took place in Montreal Canada from 2nd October to 5th…
Annex II Under the MDR: What is a Technical File?
This article draws from our experience in conducting Tech-File reviews and outlines the key requirements for Technical Files based…
Challenges Selecting Distributors as India Authorized Importers
At MedEnvoy Global, we understand the intricate landscape of medical device regulations in India, and we understand that there are…
Clinical Investigation Under the MDR: When is it Not Mandatory?
Due to the resources necessary to perform a clinical investigation under the…
Performing Clinical Evaluations: Article 61(10) Under the MDR
Under Article 61(10) of the MDR,…
IVD Regulations Within the UK: A Comprehensive Overview
Understanding the evolving landscape of UK IVD regulations as a manufacturer can be difficult when wanting to ensure the correct…
New MedDO Amendments Implemented by Federal Council
EU IVDR Labeling: Requirements and Best Practices
The term “labeling” in the European in vitro diagnostic medical device Regulation 2017/746…
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