In the European Union (EU), two significant regulations have been introduced to enhance the safety and effectiveness of medical devices – the In Vitro Diagnostic Regulation (IVDR) and the Medical Device Regulation (MDR).
Ensure your packaging meets standards with expert packaging validation. Trust us for reliable compliance every time. Packaging validation is a critical aspect of ensuring the safety and effectiveness of medical devices.
The newly proposed MDCG guidelines are a valuable resource for manufacturers , notified bodies, and stakeholders navigating the intricate landscape of medical device regulatory standards.