Provision of electronic instructions for use for devices is now a well-established practice. But there are conditions. A new Implementing Regulation explains how these apply under the Medical Device Regulation.
European Commissioner for Health and Food Safety Stella Kyriakides is calling on EU member states to “equip your authorities with the resources they need” to deal with the 11 pending applications for notified body designation under the IVD Regulation.
The possibility of providing instructions for use in electronic form instead of paper should be limited to certain medical devices and accessories intended to be used under specific conditions, the document states.
“For reasons of safety and efficiency,” it notes, “users should always have the possibility to obtain those instructions for use in paper form upon request.” The document also lays out rules for eIFU information made available on manufacturers’ websites.
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In this discussion, we provide an overview of how to plan and coordinate change within an organization to meet upcoming EU IVDR regulatory requirements. We will be highlighting key steps involved in helping medical affairs transition to a more rigorous regulatory environments, and how to evaluate talent gaps, team leadership composition, and process challenges of your product portfolio.
In this discussion, our panel of proven leaders discuss the key elements that support and propel the innovation process in the medical device, pharmaceutical, and IVD industries. We will be highlighting key areas of the process, important players in the pathway to the market, and how successful innovations spawn new innovations in new markets such as the digital health space, and more.
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