Labeling and Instructions for Use - Medical Device Design: Innovation from Concept to Market - page 269

Table 11.1: Standards and Guidelines Associated with Labels and Marking of Medical Devices

Region Title Comment

USA 21 CFR Part 801 General device labeling Freely available on FDA website

USA 21 CFR Part 812 Investigational device exemptions Freely available on FDA website

USA Guidance on medical device patient labeling; final guidance

for industry and FDA reviewers

Freely available on FDA website

USA Use of symbols on labels and in labeling of in vitro diagnostic

devices intended for professional use

Freely available on FDA website

USA Alternative to certain prescription device labeling requirements Freely available on FDA website

WO ISO 15223: Medical devices. Symbols to be used with medical

device labels, labeling and information supplied

Available online at a cost

EC Medical Devices Directive Freely available online.

EC The CE Mark: MHRA Bulletin No. 2 Freely available on MHRA website

EC / UK BS 3531-6: plants for osteosynthesis. Skeletal pins and wires.

Specification for general requirements.

Available online at a cost

Table 11.2: Labeling and IFU Needs for Specific Classes of Device

Labels IFU Device

Requirement
Device

Class I
nonsterile
item

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✯ ✔ ✔ ✯ ✔ ❑ ✔ ✔ ✔ ✔

Class I
nonsterile
- reusable
device

✯ ✔ ✔ ✯ ✔ ❑ ✔ ✔ ▲ ✔ ▲

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Class II
nonsterile
item

✔ ❄ ✯ ✔ ✔ ✯ ✔ ❑

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

Class II single
use sterile
item

✔ ❄ ✔ ✯ ✔ ❑

✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔ ✔

▲ marked on each separate item; ✯ provided on request; ❄ includes Notified Body registration number; ❑ if risk analysis
requires one.