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E-Labeling

Paper package inserts of In Vitro Diagnostics (IVD) are no longer needed, just provide the Instructions for Use (IFU) over the Internet in full compliance with the regulations.

Does this sound familiar?

Annual printing cost higher than €100.000/year.
Thick multilingual IFUs do not fit in the kit box.
Illegible texts due to small font.
Obsolete inventory after revision of instructions.
Shipping more than 2 tons of paper Instructions for Use per year.

Why are the E-Labeling services the perfect solution?

Paper leaflets can be a thing of the past. The end-user of the IVD product can download the right instructions on the website or can ask for the IFU by calling a free telephone service, without your intervention needed.

The E-Labeling Services consists of two components: a website and a 24/7 freephone service. This makes this service fully compliant with the European and FDA guidances.

The European guidance document MEDDEV 2.14/3 rev. 1 describes the condition in which manufacturers of IVD products can make Instructions for Use available to the user. These include:

IFUs must be on a dedicated website or a dedicated area of a website
Data security requirements
Users must have the opportunity to ask a copy of the IFU by calling a free telephone number
The system must be based on risk management principles.

All these requirements are covered by our E-Labeling services.