Making the change from paper instructions for use (IFU) to online eIFU can lead to huge efficiency gains and cost savings for manufacturers, but it must be done right. Diligence and attention to detail during the change process will pay off in the long-run.
Before you begin
The first thing for manufacturers to consider is whether eIFU is accepted for their type of products. According to European Commission regulations, eIFU are currently allowed for certain categories of medical device (MD), including implantable MDs and in vitro diagnostics (IVDs) for professional lab use.
In the EU, Regulation 207/2012 provides the requirements for MDs, and MEDDEV 2.14/3 (2017) contains guidelines for IVDs. NBs will verify that the eIFU's functional specifications clearly address these requirements.
Making the switch
When it comes to making the switch, manufacturers must inform the NB of their intention and prepare for an audit. The change to eIFU must be done in line with the company's change control procedure, and this includes performing an in-depth risk analysis.
The company must update IFU procedures, and create new procedures where necessary, to account for the switch to eIFU. Steps must be taken to ensure IFU and eIFU remain identical, in line with industry regulations. The labelling itself must also be updated to display an easy-to-understand symbol indicating eIFU availability.
A helping hand
Manufacturers can significantly reduce their workload and increase their compliance by choosing to outsource the switch to a qualified, reliable supplier. IFUcare's service has been developed by regulatory experts over more than ten years, with a focus on compliance and risk management.
