Next to major changes on regulation regarding the classification of products and on the performance evaluations studies for IVD and regarding the new requirements on clinical evidence and clinical investigation studies for MD, also the regulation regarding IFU’s has changed.
In Annex I, Chapter III, Point 20.1 of the regulation for IVD’s or Annex I, Chapter III, Point 23.1 of the regulation for MD’s is written: ”Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website…”
Because of this new regulation, you must set up a system to make the IFU’s available on your website. Why not turn this obligation into an opportunity and leave out the paper IFU’s at the same time, saving on paper and logistics cost and making use of all the advantages a flexible digital carrier is offering? At Qarad we are convinced it would be the right time and for sure worthwhile to combine both.
Qarad’s eIFU Services is a single supplier solution for your eIFU’s developed by an experienced team of regulatory and quality experts. It is fully compliant with EU and FDA regulations and the concept is familiar to and thoroughly reviewed by the major EU Notified Bodies.More than 50 companies, including industry leaders, store their IFU’s on a customized website on our standard platform or on a tailor-made website supporting all their requirements and are using these services for several years to their full satisfaction.
As an experienced specialist in eIFU’s, offering already a fully compliant solution, we are ready to help you to save time and cost, time that you will need for the other aspects of the new regulation.
Click here for more information on e-Labeling or contact us for a free remote live demo.