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AEMPS Provides Additional Time to Change Labels
The Spanish Agency of Medicines and Medical Devices (AEMPS) announced the extension of the period provided for medical device manufacturers to implement changes to labeling required due to Brexit. A General Overview of...
Slovenia Implements New Packaging Requirements
The new regulation adopted in Slovenia implements the labelling requirements set forth in the Commission Delegated Regulations 2016/161/EC supplementing Directive 2001/83/EC. The regulation provides detailed rules on...
EC Clarifies Status of Expert Panels
Expert Panels: Functions and Features According to the new regulatory framework set forth by Medical Device Directive (MDR) and In Vitro Diagnostic Directive (IVDR), special expert panels should be designated to...