EN980:2008 on Medical Device Labeling Released

As someone involved in the medical device industry, we wanted to make you aware that a very important update to EN 980 has just been released.

EN 980:2008 - SYMBOLS FOR USE IN THE LABELLING OF MEDICAL DEVICES
The new changes in this document are exciting and will certainly have a positive impact on medical device labeling. EN 980:2008 greatly increases the number of symbols that are recognized in Europe that can be used without further explanation.

The biggest change is that Clause 5 (Symbols in Use) has been greatly expanded to include a total of 29 symbols, up from 12 previously. These 29 symbols can now be used "without explanation in the information supplied by the manufacturer."

These are the 12 symbols from EN 980:2003, Clause 4 (now Clause 5 in EN 980:2008) that were considered "Already in Use" and needed no further explanation:

1. DO NOT REUSE
2. USE BY
3. BATCH CODE
4. SERIAL NUMBER
5. DATE OF MANUFACTURER
6. STERILE - FOR TERMINALLY STERILIZED DEVICES
7. STERILE - STERILIZED USING ETHYLENE OXIDE
8. STERILE - STERILIZED USING IRRADIATION
9. STERILE - STERILIZED USING STEAM OR DRY HEAT
10. STERILE - STERILIZED USING ASEPTIC PROCESSING TECHNIQUES
11. CATALOGUE NUMBER
12. CAUTION

These 10 symbols were included in EN 980:2003, Clause 5, but were considered "New Symbols" and therefore needed to be "explained in the information supplied by the manufacturer." In EN 980:2008 (Clause 5), these are now listed as "Symbols Already in Use" and no longer need to be explained.

1. MANUFACTURER
2. AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY
3. SUFFICIENT FOR
4. FOR IVD PERFORMANCE EVALUATION ONLY
5. IN VITRO DIAGNOSTIC MEDICAL DEVICE
6. TEMPERATURE LIMITS: UPPER AND LOWER
7. TEMPERATURE LIMITS - UPPER
8. TEMPERATURE LIMITS - LOWER
9. CONSULT INSTRUCTIONS FOR USE
10. BIOLOGICAL RISKS

The following seven symbols were also added to EN 980:2008 (Clause 5) and were taken from ISO 15223-1:2007. They can be used without further explanation and include:

1. KEEP AWAY FROM SUNLIGHT
2. KEEP DRY
3. DO NOT RESTERILIZE
4. NON-STERILE
5. CONTROL
6. NEGATIVE CONTROL
7. POSITIVE CONTROL

Finally, three entirely new symbols have been introduced. They must be explained in the information provided by the manufacturer:

1. CONTAINS OR PRESENCE OF NATURAL RUBBER LATEX
2. DO NOT USE IF PACKAGE IS DAMAGED
3. STERILE FLUID PATH

The biggest impact of these changes to EN 980 is that the 10 symbols previously listed in EN 980:2003 Clause 5 (plus the additional 7 symbols from ISO 15223:2007) do not need to be explained. That means you no longer need to provide explanatory notes in your Instructions for Use, thereby simplifying translations and facilitating your compliance with the Essential Requirement that encourages the use of symbols.

We hope you find this information helpful.

Best Regards,

Evangeline Loh PhD RAC (US, EU)
Director of Regulatory Affairs
Emergo Group, Inc.