Notified Bodies
Independence and Neutrality
DEKRA Certification GmbH and DEKRA Certification B.V. are Notified Bodies and Certification Bodies for medical devices.
As a Notified Body with the identification number 0124, DEKRA Certification GmbH, and as a Notified Body with the identification number 0344, DEKRA Certification B.V. accompany conformity assessment procedures for medical devices in accordance with Directive 93/42/EEC, Regulations (EU) 2017/745 and (EU) 2017/746 for companies placing medical devices on the market. In addition, accredited certification bodies, they certify quality management systems according to EN ISO 13485 for companies involved in the manufacturing, distribution or supply chain of medical devices.
Important documents of DEKRA Certification GmbH:
- General Terms & Conditions (GTC) (PDF, 49 KB)
- General Certification Conditions (GCC) for Medical Devices (PDF, 239 KB)
- Special Certification Conditions (SCC) for MDR/IVDR (PDF, 180 KB)
- Special Certification Conditions (SCC) for Medical Devices under Regulation (EU) 2017/745 Article 120 (3) (PDF, 130 KB)
- Information about Incident Notification to DEKRA D-091-32 (PDF, 111 KB)
- Notification of Significant Changes (PDF, 66 KB)
- Change Notification Medical Devices (PDF, 290 KB)
- Processing of Incident Notifications, Recalls, FSCA and FSN (PDF, 111 KB)
- Application form for Medical Devices (PDF, 318 KB)
- Attachment Application Form for Medical Devices (PDF, 144 KB)
- Price List for Medical Devices (PDF, 71 KB)
- Price List for Medical Devices MDR/IVDR (PDF, 75 KB)