eIFU is NOT easy… But it can be

Although FDA and MDR allow eIFU to be used, the Australian TGA has provided the clearest guidelines on requirements of eIFU.  The first eIFU platform I worked on and implemented was over twenty years ago.  If requirements are well defined, and technology is not a major roadblock what is the hardest part of implementing eIFU?  Why is it so hard?

Based on experience, there are two challenges that seem difficult to overcome regardless of size of the organization:

1. Software validation and software creation are not typically a strength of medical devices
2. eIFU is usually managed by document control or labelling specialist with little experience with process development.

More recently, annual postmarket surveillance reports PSUR and SSCP and other types of documents create complexity with managing eIFU.

A common situation is having a team comprised of Document Control/Labelling Subject matter experts, Quality, and IT resources with the goal of creating and implementing software specifications/development/validation with minimal templates.  The result is often bureaucratic gridlock as daily activities take precedence over project progress.

A potential solution that medical devices can manage easily:  Outsource the activity to a service provided that can be managed through existing supplier management controls. Added benefit: Risk management, software validation, and maintenance do not have to be recreated when the work has already been completed.

After outsourcing the activity to post information online, the following changes can be implemented quickly:

Step 1: link to information added to the company website to the eIFU information. This would require verification of the link and some type of periodic monitoring that can be easily performed and documented. Periodic verification is a common acceptance activity that Quality has core competency experience with implementing. 

Step 2: add the link to the IFU and labeling as required with the electronic IFU symbol per ISO15223 (eIFU symbol can be found https://www.iso.org/obp/ui/#home and enter ‘Electronic Instructions for Use’).  Transition IFU and labelling at a pace appropriate for the business.

Step 3: Update labeling procedure to include a step to complete forms with the service. 

Take advantage of a robust architecture with a secure and validated system developed specifically designed to manage documentation online.

Enabling online document management does not have to be hard. Try the link below and post online information:

eIFU and Online Documentation – QMS Velocity