ISO 13485:2016 Active
v1.0
DocumentsRegulatory SubmissionsREG-006
Document Number
REG-006
Version
v1.0
Classification
CONTROLLED DOCUMENT
Effective Date
May 7, 2026
Author
Regulatory Affairs
Owner
Regulatory Affairs
ISO Clause
N/A
Tier Level
Tier 2 — SOP/Plan

Technical file structure per EU MDR Annexes II and III for CE Mark submission.

#eumdr#ce-mark#technical-file
Approval Status
Draft
Effective: May 7, 2026
Regulatory Standards
EU MDR 2017/745ISO 13485:2016

Revision History

VersionDateAuthorDescription
v1.0May 7, 2026Regulatory AffairsInitial release