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!
eIFU Flyer
eIFU Flyer
Download our new E-Labeling flyer and learn about the possibilities!

Testimonial

« Qarad has been very helpful in our recent transition from paper to electronic Institutions For Use. They offer a very professional eIFU service and platform. Changing to eIFU doesn’t only save us cost but it’s also very efficient. And off course good for the environment. Every company should basically be doing this. Apart from being very client focused and flexible, the Qarad team has excellent and up to date regulatory knowledge. »

Peter Kievit
General Manager White Implants

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