EC Outlines Rules for Electronic IFUs

On December 14, 2020, the EC outlined rules for electronic IFUs. The question now becomes . . . what are the implications of this?

Simply put, taking advantage of the cost savings and risk reduction inherent with moving to eIFUs involves two primary areas of consideration. Specifically:

  1. Delivery of the eIFU service itself and . . .
  2. Delivery of the labeling related changes that must coincide with other changes.

Delivery of the IFU

Pre-launch activities involve:

  • Planning
  • Reviewing internal quality procedures
  • Risk Assessment
  • Implementation
  • System Validation

Providing quality on-going eIFU services involves:

  • A multilingual website interface and multilingual phone services provided worldwide that is free of charge for callers.
  • Delivery of paper based IFUs free of charge to requesters within 7 days of request.
  • Archived eIFUs in some cases, being made available for a periods of up to 15 years.
  • Maintaining a system to clearly indicate when the eIFUs have been revised and it must inform each user of the device if the revision was necessary for safety reasons.
  • Verifiable levels of security and high availability for the eIFU hosting website.

Delivery of labeling changes

The associations between products requiring an eIFU, the versions of eIFUs and also patient facing information must be managed. This endeavor includes the translations of various languages and the replacement of existing versions of electronic documents. And this occurs whenever new documents have been created, reviewed, approved and readied for posting. Multiple documents may need to be related to the same products and printed at packaging time. Also, changes must be made to actual product labels to indicate that an eIFU is available. A strong Destination Labeling component has the ability to tie everything together and accomplish all of this nicely through automation.

The ROBAR system by Innovatum with its associated delivery and support services eases the transition to eIFU. Associations between products, various IFU and eIFU versions, languages and on-going histories of prior versions are stored in the ROBAR Master Data Management database. This is exactly what is needed for accurate and efficient Destination Labeling. Data is used to update hosted web based systems to ensure that the most current, approved, version specific, language specific and historically tracked information is made available appropriately.