CE Marking Procedure

SKU: SOP 7-040
$149.00
$149.00
Unavailable
per item
The CE Marking procedure governs the content of CE Technical Files and Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with Medical Device Regulation MDR (EU) 2017/745. 
  • ​ MDR EU 2017/745 Compliant
  •  ISO 13485:2016 Compliant
  • ​ MEDDEV 2.4.1 Compliant
  •  MS Word Format
  •  Instant Download Digital Content

CE Marking Procedure

The CE Marking Procedure provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.​

CE Marking Procedure - Overview

The CE Marking Procedure provides detailed instruction on the creation, content and routine maintenance of CE Technical Documentation / Design Dossier's. The CE Marking Procedure also provides instruction on device classification in accordance with the Medical Device Regulation MDR (EU) 2017/745.

CE Marking Procedure - Compliance

The CE Marking Procedure is ISO 13485:2016 and MDR (EU) 2017/745 compliant.
​For more information about our CE Marking Procedure contact us at info@aplyon.com 

RELATED LINKS

​​Medical Device Labeling Procedure Bundle
Medical Device Quality Management System Base Plus
Medical Device Quality Management System Design Plus
​Medical Device Quality management System Manufacturing Plus
CE Marking Procedure
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