In Europe, manufacturers of certain categories of medical devices can replace paper IFU with an electronic version. Notified Bodies will verify how a manufacturer has designed and implemented their eIFU solution.
To Notified Bodies, the implementation of an eIFU solution is a significant change to the quality management system (QMS). Manufacturers must submit a change application and provide evidence of correct implementation.
Risk Management And Design
Notified Bodies expect manufacturers to define user requirements and go through the process all the way to validation. The user requirements must clearly address the requirements from regulation 207/2012 and MEDDEV 2.14/3. Risk management deserves special attention – manufacturers must assess the risks caused by the absence of a paper copy.
Review Of Labeling
Notified Bodies will verify how the manufacturer leads the user to the correct eIFU. The information must be available on the device or packaging, most efficiently via a URL combined with a symbol.
Review Of The QMS
The Notified Body will check changes to procedures for management of eIFU, label content, inventory management, packaging, logistics, and the impact on the ERP system.
Conclusion
The workload can be considerably reduced by choosing an outsourced compliant solution, designed by an ISO13485 certified supplier and hosted under an ISO27001 certified information security management system.
