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Electronic Labelling for Medical Devices and IVDs

Topic : Regulation Type : Briefing

Manufacturers may need to provide information about a medical device or in vitro diagnostic medical device so that it can be used safely and properly for its intended purpose. Information can appear on the device itself, on a label, on packaging or in the instructions for use. The term ‘labelling’ includes the label, instructions for use, and other information but excludes shipping documents. Labelling information identifies the device and its manufacturer and where necessary gives instructions on how the device should be safely used and stored and what performance can be expected.  

Information may be supplied by the manufacturer in physical form, for example as a paper insert or label, it may be supplied remotely via a website or app for reading/download, or via a code on the device packaging. The code can be human readable such as a website URL or phone number, or it may be machine readable such as a QR code, barcode, radiofrequency tag or digital watermark. Code readers could be specialised (barcode scanner) or more readily available (smartphone). Information may also be provided separate to the device in a physical, non-paper form (in local information systems or electronic storage media). It may be necessary to include some minimum information with the device (e.g. batch specific info, user reporting e.g. Yellow Card). Manufacturers can also provide Unique Device Identifiers in machine-readable format (e.g. radio frequency identification/RFID or barcodes). 

Services to support access to device information can be provided by the device manufacturer, or subcontracted to the authorised representative, distributor or other third party provider. 

The MHRA has provided guidance on the use of electronic instructions for medical device and referred to EU guidance on the use of electronic instructions for use. In addition, the EU has set out regulations on electronic instructions for use for specified devices. Both the EU and the UK restrict the use of electronic labelling to only the instructions for use and not the label on the device itself. EU regulations allow machine-readable information to supplement human-readable labels on the device or its packaging. Electronic instructions are further restricted to professional users only. Paper copies must be available to users on request.  

Whilst the global uptake of electronic instructions is high and includes several members of the International Medical Device Regulators Forum, there could be even greater application to a wider range of devices and users. IMDRF has issued guidance that includes the use of electronic instructions, however, the guidance stops short of the conditions in which electronic instructions can be used.  

Pharmacists and other health and care professionals can keep themselves better informed about device use and performance by accessing electronic labelling without having to open the device package. Potentially electronic labelling could be used as the basis of a HealthTech compendium (perhaps via a link to a national database) and could also help regulators to identify counterfeits and non-compliant devices. 

Electronic labelling can be more accessible to a wider range of users, including people with visual impairments and other disabilities and can be readily updated with technical or safety changes. Electronic methods of reporting safety information to regulators and manufacturers can also be included. Reducing paper consumption, printing, distribution, and disposal could help sustainability efforts. 

Steve Lee, Director, Diagnostics and Digital Regulation