1. Administrative particulars
Source: CER Template.pdf page 7 (document: Mantra Systems Free CER Template, Edition 2)
This introductory section has three subsections:
- Title page
- Contents page
- Administrative particulars summary
The administrative particulars summary section is intended to give a reviewer quick access to key facts about the subject device, including:
- Name
- Model number
- Basic UDI-DI
- Manufacturer address
- Risk classification
- Intended purpose
- CER authors
- Date of CER