Label, Labelling vs Instructions for Use (IFU)?

1. A Label is the written, printed, or graphic information that goes on the packaging of the medical device.

2. Instructions For Use (IFUs) or Package Insert is the essential information accompanying the medical device for its safe and effective use by the user. It can be a single to multiple-page document.

3. Labelling is the content that goes on the Label or IFUs.

What are the minimum requirements for labeling?

The ISO has published many standards applicable to the medical device industry. Some of them are as below:

ISO 20417 has defines information to be disclosed by the manufacturer. Every medical device manufacturer, distributor, importer, or Authorized Representative is bound to comply with the standard before placing the device on market. The requirements are as follows:

Information on Label

1. Manufacturer details – Trade Name, address, country

2. Product description

3. Product identification – model or catalogue number, Lot number, serial number, expiry date, UDI,

4. Storage instructions

5. Operating instructions

6. Warning or precautions

7. Presence of any harmful substances (>0.1% w/w), biological origin substances, medicinal substances, nanotechnology materials

8. Electronic IFUs (if available)

9. Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse

10. If Sterile and method of sterilization

11. Explanation of safety-related colors

Information on Packaging

1. Name and address of the manufacturer or an authorized representative

2. UDI

3. Production controls – lot number, serial number, expiry date

4. Model number, catalog number, commercial name

5. Mention of: Single-use/ Single patient multiple-use / Reuse / Limitation on reuse

6. Storage or special handling requirements

7. Any special requirements for battery-powered medical device

8. Contraindications, warnings, or precautions

Information in IFUs

1. General information (as above)

2. Intended Use of the medical device

3. Safety information

4. Performance of the medical device

5. Any residual risk associated with the use of the medical device or its accessory

6. Any known contraindications

7. Document control number of the IFU

8. Safe disposal information

9. Any specific instructions for handling or preparatory treatment

10. Any warnings, precautions, or limitations

11. If any accessories or indicators are provided along with the device, instructions on their use to be provided in the IFU.

12. Technical description

13. The harmonized ISO standard makes sure true and uniform information is conveyed to a lay/common person.

Global Labelling Requirements

Most countries have a mandatory requirement for the IFUs or Labels in their local language. To streamline this requirement, ISO 15223 standard provides a list of signs and symbols that depict common terms such as Manufacturer, Lot number, storage conditions, Expiry, eIFU and many more.

The uniform symbols help in identifying the necessary information without the language barrier. Another advantage is it saves significant label space.