SYS-030 Labeling Procedure

Labeling checklist forms and labeling templates are included with this procedure. These documents are updated for ISO 13485:2016 and the new European Regulations, (Regulation EU 201/745 MDR, and Regulation EU 2017/746 IVDR).

The following is a list of documents included:

SYS-030 A, Labeling Procedure
FRM-033 A, EU MDR Regulation EU 2017-745 Labeling Requirements Checklist
FRM-036 A, FDA and CMDR Labeling Requirements Checklist
TMP-006 A, IFU Template
TMP-007 A, Label Template

General Device Labeling - 21 CFR Part 801
Use of Symbols - 21 CFR Part 801.15
In Vitro Diagnostic Products - 21 CFR Part 809
Investigational Device Exemptions - 21 CFR Part 812
Unique Device Identification - 21CFR Part 830
Good Manufacturing Practices - 21 CFR Part 820
General Electronic Products - 21 CFR Part 1010