For EU CE certification of Class C medical devices, compliance with several key standards is essential to meet the requirements of the EU Medical Device Regulation (MDR) 2017/745. The relevant standards include:

1. EU Medical Device Regulation (MDR) 2017/745

• Core Regulation: Governs the overall requirements for medical devices in the EU, including classification, safety, performance, and documentation.

2. ISO 13485:2016

• Quality Management System (QMS): Specifies requirements for a quality management system for medical devices, ensuring consistent product quality and regulatory compliance.

3. ISO 14971:2019

• Risk Management: Provides guidelines for managing risks associated with medical devices, including risk analysis, evaluation, control, and monitoring throughout the device's lifecycle.

4. ISO 10993 Series

• Biocompatibility: Covers the evaluation of biocompatibility for medical devices, including testing for cytotoxicity, sensitization, irritation, and other biocompatibility assessments.

5. IEC 60601 Series

• Electrical Safety: Applies to the safety and performance of electrical medical equipment. Key standards include:
  • IEC 60601-1: General requirements for basic safety and essential performance.
  • IEC 60601-1-2: Electromagnetic compatibility (EMC) requirements.
  • IEC 60601-1-6: Usability engineering.

6. ISO 14155:2020

• Clinical Trials: Provides guidelines for the design, conduct, and reporting of clinical trials involving medical devices.

7. ISO 20417:2021

• Device Information: Specifies requirements for information supplied by the manufacturer, including labeling and instructions for use.

8. IEC 62366-1:2015

• Usability Engineering: Focuses on the usability of medical devices, ensuring that they are designed to be safe and effective for their intended use.

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