ROBAR Docs

eLabeling Dramatically Streamlines Processes, Increases Efficiencies, all while Reducing Costs 

A complete eLabeling system can be difficult and expensive to set up, maintain, and validate, but Innovatum makes the integration of eIFUs easy and cost effective. 

Electronic IFUs (eLabeling) saves money on printing and shipping costs and minimizes risk by providing quick updates and version tracking. Processes are streamlined and efficiencies are increased. It reduces and can even eliminate the expense and adverse effects of scrapping paper printouts. EU MDR & IVDR regulations will soon cause a steady flow of changes to the designation of Notified Bodies. Trying to keep paper-based IFUs up-to-date with these changes will quickly become an expensive and unsustainable approach. Innovatum has the answer that solves all of these challenges within one integrated solution that is available in modular format!

The regulations that govern eIFU’s are:

For Medical Devices (MD): COMMISSION REGULATION (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices.

For In Vitro Diagnostic Devices (IVD): MEDDEV 2.14/3 rev.1.

 

Difficult and Expensive Requirements Made Easy:

Requirement– Setting up and maintaining a compliant eIFU website per Annex I, Chapter III, Point 20.1 of the regulation for IVD’s or Annex I, Chapter III, Point 23.1 “and shall, if the manufacturer has a website, be made available and kept up to date on the website…”

Solution– A hosted eIFU website assists a company with meeting these requirements

Requirement– Setting up a toll-free phone network and staffing with multi-lingual persons who are capable of speaking with medical professionals across several countries:

  • Complying with Commission regulation (EU) no 207/2012
    • Users should always have the possibility to obtain in paper form
    • …have system in place
      • to provide paper version
      • at no additional cost to recipients
      • the latest within 7 calender days

Solution– A global free phone service that is staffed 24/7 and can deliver IFUs in the requested language and format

Requirement– Validation and demonstrating 21 CFR compliance for an eLabeling system

Solution– A quality approach that is audit and risk management driven:

  • Business risk analysis service and almost 1,000 pages of validation documentation to prove that website and freephone service are compliant with applicable regulations including security requirements and system availability
  • Planned integration with the ROBAR labeling system to automatically tie IFUs and eIFUs to the lot level, manage versions and make the most current eIFU version appear on the website

 

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