FDA approved the use of electronic labelling for prescription medical devices intended for use in U.S. healthcare facilities in 2003.1 In the European Union, guidance on providing electronic instructions for use (EIFUs) for in vitro diagnostic devices has been available since 2007.2 In March 2012, the EU Commission published EIFU regulation for certain types of medical devices, and the regulation came into effect on March 1, 2013.3
Applicable Device Types
Commission Regulation EU 207/2012 on EIFUs for medical devices is applicable in all EU member States without the need for any member state transpositions. The regulation defines EIFUs as instructions available from a Web site, supplied in portable electronic media (e.g., CD, DVD, USB drives), or displayed in electronic form on the product screen. In the latter two cases, manufacturers are also required to provide instructions on a Web site. The regulation allows EIFUs for the following types of devices:
- Active implantable medical devices and their accessories, covered by Directive 90/385/EEC (AIMDD) and intended to be used exclusively for the implantation or programming of a defined active implantable medical device.Implantable medical devices and their accessories, covered by Directive 93/42/EEC (MDD) and intended to be used exclusively for the implantation of a defined implantable medical device.Fixed installed medical devices covered by Directive 93/42/EEC.
- Medical devices and their accessories, covered by Directives 90/385/EEC and 93/42/EEC and fitted with a built-in system visually displaying the instructions for use.
- Stand-alone software covered by Directive 93/42/EEC.
EIFUs for such devices can be provided only when they are intended for exclusive use by professionals (e.g, in a healthcare setting) and use by others is not reasonably foreseeable. If the device design requires that a part of the instructions is intended to be provided to the patient, the regulation requires that part to be in paper form.
Advantages and Risks of EIFUs for Medical Devices
EIFUs can also include video and audio files demonstrating device installation, operation, implantation, and handling, which can enhance the safe use and help achieve their intended performance. Manufacturers can also easily and quickly update the EIFU content based on postmarket surveillance data to further enhance device safety.
The costs associated with paper and printing can be greatly reduced, along with the environmental footprint, while enhancing speed-to-market of products. Economic benefits could also come by avoiding expensive recalls associated with inaccurate information provided in paper IFUs.
Key risks associated with EIFUs include delayed or no access to the instructions for use in healthcare settings and inadequate security provisions related to the EIFUs.
Safety is the Key Principle
The regulation allows EIFUs to be provided in addition and as an alternative to paper, with specific requirements. Most manufacturers are expected to provide EIFUs instead of paper IFUs, although there are greater risks associated with this method. Accordingly, the requirements to do so are slightly more burdensome.
Manufacturers must clearly indicate on the device or sales package that the instructions for use are provided in electronic format instead of paper. In the case of fixed installed medical devices this indication should be provided on the device itself. As yet, there is no harmonized symbol to indicate the presence of EIFUs, so any symbol must be explained in paper IFUs or an accompanying leaflet provided with the device.
Content-wise, EIFUs must at least meet the applicable essential requirements related to instructions for use listed in either MDD or AIMDD. They may also contain additional audio or video files to enhance the utility of the instructions.
Manufacturers are required to carry out a documented risk assessment towards the provision of EIFUs that considers, among other things, the following, :
- The knowledge and experience of the intended users.
- The environment where the device will be used.
- User access to electronic resources at the time of use.
- Impact of temporary unavailability of the EIFU Web site.
- Performance of safeguards against tampering of electronic data and content.
These risk assessments must be regularly updated with postmarket data and should demonstrate that providing EIFUs maintains or improves the level of safety compared with paper form.
In addition to risk assessments, the EIFU regulation has several obligations the manufacturer must meet to ensure patient safety and overcome any risks associated with the provision of EIFUs, as follows:
- Provide EIFUs in all member states where the device is available unless otherwise justified in the risk assessment.
- Provide a paper copy of the IFU within seven calendar days if requested at no additional cost to the user.
- Provide information on foreseeable medical emergency situations, either on the device or on a leaflet accompanying it.
- Inform each user if the instructions for use have been revised for safety reasons.
- Provide EIFUs in a commonly available format and provide information on the hardware and software requirements needed to display them.
- Ensure IFUs are available for at least two years after the end of the expiry date of the last produced device or 15 years after the last manufactured device in case of implantable devices or devices without a defined expiry date.
- Create special Web site requirements, such as protection against hardware and software intrusions to minimize server downtime and display errors.
Notified Body Assessments
The regulation requires that notified bodies (NBs) review EIFUs for all devices except for Class I devices and verify compliance with applicable requirements of the EIFU regulation as a part of the conformity assessment procedure. NB reviews will be based on a sampling method appropriate to the device classification and complexity. EIFUs for Class III devices will receive the highest scrutiny.
The regulation requirements cover several issues including content, access, risk analysis, verifications and validations, special obligations, and Web site requirements. Some of these requirements are more quality system based (e.g., the requirement to provide paper IFUs within seven calendar days of request) and lend themselves to quality management system (QMS) audits. Others are more technical in nature (e.g., the content of EIFUs themselves and risk analysis). Although each NB might have a slightly different approach, manufacturers should expect a mix of quality system and technical documentation assessments from the NB in the approval of EIFUs. The NB will most likely expect the EIFU Web site to be functional prior to these assessments.
As a part of the continuous assessment visits, NBs may audit postmarket surveillance data to ensure that the transition to EIFUs has not led to deterioration in safety levels associated with the device.
Manufacturers must consider the risks and benefits in moving towards EIFUs. While the requirements of the EIFU regulation may appear burdensome, manufacturers making the transition can yield economic benefits and improve patient safety and satisfaction.
The EU Commission has laid the groundwork for electronic labelling. Although the scope of the EIFU regulation is limited to certain types of devices, it should soon include other categories once the impact is fully analyzed. Manufacturers preparing their business processes and content management systems to transition to EIFUs could hold significant advantage over competitors.
- “Electronic Labeling for Prescription Devices Intended for Use in Health Care Facilities” Medical Device User Fee and Modernization Act (MDUFMA) (2009).; available from Internet: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalD....
- “MEDDEV 2.14/3 rev 1: IVD GUIDANCES: Supply of Instructions For Use (IFU) and Other Information for In-vitro Diagnostic (IVD) Medical Devices,” EU Commission; available from Internet: ec.europa.eu/health/medical-devices/files/meddev/2_14_3_rev1_ifu_final_en.pdf.
- “Commission Regulation (EU) No 207/2012 of 9 March 2012 on Electronic Instructions for Use of Medical Devices Text with EEA Relevance,” EU Commission.; available from Internet: eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:072:0028:01:EN:HTML.
Jayanth Katta, PhD, is a certification manager and device expert at BSI Healthcare (Grand Rapids, MI). Before joining BSI, he was the chief scientist at a start-up medical device company based in Philadelphia. He holds a PhD in bioengineering from the University of Leeds, UK.