E-Labeling


Paper package inserts of In Vitro Diagnostics (IVD) and of certain groups of Medical Devices (MD) are no longer needed, just provide the Instructions for Use (IFU or e-IFU) over the Internet in full compliance with the regulations.

Does this sound familiar?

  • Annual printing cost higher than €100.000/year.
  • Thick multilingual IFU does 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 or MD can download the right instructions on the website or can ask for the e-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 conditions 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.

EU Regulation 207/2012 describes the conditions in which manufacturers of MD products can make Instructions for Use or e-IFU available to the user.

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

What are the two components of E-Labeling?

 E-Labeling.eu website  E-Labeling freephone service
User friendly
Multilingual
No software needed
Marketing tool for manufacturer
Safe
Worldwide
24/7
Multilingual


E-Labeling Services: practical

Our support:
  • In compliance with the regulatory requirements
  • Validation of the website and the freephone services
  • Validation packages available
  • Designed after risk analysis
  • Advise on labeling
  • Assistance in implementation

For more information visit our website http://www.e-labeling.eu/ or Contact us

Schedule a Live Demo!

Contact us to schedule a live demo and learn more about how your company can profit from our E-Labeling Service!
E-Labeling Flyer
E-Labeling Flyer
Download our new E-Labeling flyer and learn about the possibilities!