The United States, with a population nearing 340 million, stands as the foremost medical device market globally, accounting for over 40% of the international market share. Its continuous growth spells abundant opportunities for medical device companies worldwide seeking US FDA medical device registration.
Implementing Decision (EU) 2025/2078 updates harmonised standards for surgical drapes, gowns, clean air suits, medical face masks, and sterilizers under the EU MDR. The revised EN 13795, EN 14683, and EN 14180 standards ensure product safety, quality, and performance in line with the latest scientific developments. Manufacturers should update testing and documentation to maintain conformity and regulatory compliance.
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