1、Symbols and information to be provided with medical devices and IVDs in the EU A BSI white paperAuthorsJason Mead,Principal Technical Specialist&Scheme Manager,BSIMaddalena Pinsi,Associate Head of Medical Devices Notified Body and Senior Regulatory Lead,BSIYann Fredholm,Senior Technical Specialist&S

2、cheme Manager,BSISymbols and information to be provided with medical devices and IVDs in the EU BSI 2024.All rights reserved.Contents11Label requirements13IFU requirements17Implant card requirements1Introduction and background 2General safety and performance requirements(GSPR)7Harmonized standards8U

3、se of symbolsEconomic operators responsibilitiesSymbols and information to be provided with medical devices and IVDs in the EU BSI 2024.All rights reserved.1Introduction and backgroundThe information supplied with the device is a fundamental requirement for the safe use of a medical/in vitro diagnos

4、tic device.The instructions for use(IFU)are crucial as they inform the user of a devices intended purpose and of its proper use,as well as any precautions to be taken.Being aimed at ensuring that the devices are used in a safe and effective way,it is vital that the information provided is adequate f

5、or the device itself.The label is defined in the Regulations as the written,printed or graphic information appearing either on the device itself,or on the packaging of each unit or on the packaging of multiple devices.Therefore,it can assume not only the form of a text,but also that of a graphic and

6、/or,of a symbol.The labeling includes the implant card,to be provided to patients who have been implanted with a device.This allows rapid access to information related to the identification of the device itself as well as details on the manufacturer.The information supplied with the device is checke