ABSTRACT

The Medical Device Regulation (MDR) 2017/745, effective since 2021 May, 93/42/EEC, the previous Medical Device Directive (MDD), has been replaced. to enhance device performance and patient safety in the EU. Recent 2023 amendments focus on notified body requirements, performance and safety standards, technical documentation & post-market surveillance, and specific provisions for single-use devices. These changes aim to address evolving industry challenges and ensure continued safety and efficacy of medical devices. It is anticipated that the modifications will improve quality, which will benefit the patients. Keywords: Medical device, annex and articles, amendments and corrigendum
Publication date: 01/11/2025

https://ijbpas.com/pdf/2025/November/MS_IJBPAS_2025_9583.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.11.9583