Understanding Article 10 of EU MDR 2017/745: Manufacturers’ Obligations Explained
The European Union Medical Device Regulation (EU MDR) 2017/745 is a comprehensive regulatory framework that governs the safety and performance of medical devices in the EU market. Among its core provisions, Article 10 – General Obligations of Manufacturers – serves as a foundational pillar that shapes how manufacturers bring their products to market and manage them throughout their lifecycle.
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