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The regulation of medical devices plays a crucial role in ensuring the safety and efficacy of medical devices used daily in patient care. This chapter provides a comprehensive overview of the direct and indirect regulation of medical devices in Germany and Europe, focusing on the transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It highlights the historical context, challenges faced, and the introduction of new regulations aimed at further enhancing safety, performance, and transparency. The chapter also discusses the current regulatory framework, key requirements, and the impact of broader European regulations such as REACH, RoHS, and GDPR on the medical device industry, as well as future developments.

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Direct and Indirect Regulations for Medical Devices in Europe and Germany

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  • 出版模式：

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  • 发表日期：

    2026年

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  • Marie-Isabel Dalügge

摘要

The regulation of medical devices plays a crucial role in ensuring the safety and efficacy of medical devices used daily in patient care. This chapter provides a comprehensive overview of the direct and indirect regulation of medical devices in Germany and Europe, focusing on the transition from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR). It highlights the historical context, challenges faced, and the introduction of new regulations aimed at further enhancing safety, performance, and transparency. The chapter also discusses the current regulatory framework, key requirements, and the impact of broader European regulations such as REACH, RoHS, and GDPR on the medical device industry, as well as future developments.