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Requirements under the EU Medical Device Regulation (MDR 2017/745)

Under the European Union Medical Device Regulation (MDR 2017/745), dental handpieces must obtain CE certification before being marketed in the EU. Manufacturers must ensure compliance with Annex I’s General Safety and Performance Requirements (GSPR), covering product design, material safety, noise level, and sterilization performance. A comprehensive Quality Management System (QMS) and post-market surveillance plan must also be implemented.

2025-11-11

Under the European Union Medical Device Regulation (MDR 2017/745), dental handpieces must obtain CE certification before being marketed in the EU. Manufacturers must ensure compliance with Annex I’s General Safety and Performance Requirements (GSPR), covering product design, material safety, noise level, and sterilization performance. A comprehensive Quality Management System (QMS) and post-market surveillance plan must also be implemented.

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Excerpt from the Regulations on the Supervision and Administration of Medical Devices (China)

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Excerpt from the Regulations on the Supervision and Administration of Medical Devices (China)

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