An UDI is a distinct numeric or alphanumeric code used to identify medical devices throughout healthcare supply chains. These codes are generated by product owners based on globally accepted standards for device identification.

The UDI code consists of two standard elements, which are:

• Device Identifier (DI): DI identifies the labeler and the model or version of a device. The DI is a required component and considered to be the static portion of the UDI, meaning that it is the same for all instances of the product model or version.
• Production Identifier (PI): PI identifies one or more variable characteristics, such as manufactured date, expiration date, lot number, or serial number. The PI is considered to be the dynamic portion of the UDI, meaning that the PI value changes according to the production controls.

The DI is always first and is followed by the PI if it has a value.

Unique Device Identifier (UDI) = Device Identifier (DI) + Production Identifier (PI)

There are different Issuing Agencies/ Entities for issuing an UDI for a medical device they are:

GS1: Global Standards 1 (GS1) are a nonprofit standards agency, GS1 sets international standards for supply chains, electronic data exchange, healthcare, and more. GTIN (Global Trade Item Number) and UPC (Universal Product Code) are GS1 standards, both are numeric only codes. GS1 provides a “GS1 Company Prefix” to a subscribing organization and reserves a range of “Item Reference” numbers for the organization to assign to their product portfolio. GS1 charges an initial fee and a lower annual renewal fee for the subscription. GS1 is used by the majority of medical device manufacturers.

HIBCC: Health Industry Business Communications Council (HIBCC) is a nonprofit organization focused on setting standards for the healthcare industry. The HIBC (Health Industry Bar Code) standard is managed by HIBCC and is an alphanumeric code. HIBCC provides a Labeler Identification Code (LIC) to an organization after paying a one-time subscription fee. The organization creates and assigns Product/Catalog Numbers (PCN) to their product portfolio without an additional charge.

ICCBBA: International Council for Commonality in Blood Banking Automation (ICCBBA) is a non-governmental organization. ICCBBA focuses exclusively on standards for medical products of human origin, such as blood products, tissues, and organs for transplant. It manages the ISBT 128 standard used in more than 75 countries. Only a few niche medical devices are identified using the ICCBBA standard.

Issuing Agency standards typically define a device identifier to encode a company, a product model, a package level, and a check character used to verify the accuracy of the code. 

UDI codes are included on the product and package labels and, in some cases, printed directly on the device itself. Regulations require the UDI be presented in both Automatic Identification and Data Capture (AIDC) and Human Readable Interpretation (HRI) formats.

The AIDC format is a one- or two-dimensional barcode. This format allows the product to be identified quickly and accurately by using barcode readers and scanner technologies. The HRI text format refers to easily readable text that allows the product to be identified by humans without the use of any scanning or barcode reader technology.

In the case of reused and reprocessed devices, such as a surgical scalpel, the UDI must be directly marked on the product, as the product packaging is discarded. There are different direct marking technologies such as laser etching, to mark the product for the life of the product.

Once the UDI is issued, the data must be securely stored in the manufacturer’s repository and submitted to the respective health authority’s Unique Device Identification Database (UDID).

In general, regulations require product UDI data to be reported to the UDID before the medical device is placed on the market. The UDI Device Identifier and numerous other data attributes need to be collected and submitted to the UDID.

An increasing number of health authorities are implementing UDI requirements to improve patient safety and the patient experience. Accurate, comprehensive product information gleaned from UDIDs is essential to ensure the correct and safe use of devices by all users, including patients, caregivers, healthcare providers, hospitals, and industry.

The primary goal of a UDI system is to ensure proper adverse event reporting among medical devices. UDI increases the accuracy of product traceability and enables medical device manufacturers, regulatory bodies, and other analysts to discover trends earlier and respond quicker in the event patient safety is at risk due to a certain device issue.

In order to effectively streamline UDI labeling and submissions for your medical devices, it is essential to have a thorough understanding of the entire process of development, validation, design, and submission of requirements. DDi offers a single Unique Device Identification (UDI) solution that meets compliance requirements across all countries.

In general, an eIFU is defined as a non-paper version of the instructions for use. Currently, the definition of an eIFU is not the same in each market.

In the EU, according to the Commission Implementing Regulation EU 2021/2226, which laid down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council in regards to electronic instructions for use of medical devices, instructions for use in electronic format means “instructions for use displayed in electronic form by the device, contained in portable electronic storage media supplied by the manufacturer together with the device, or made available through software or website.”

European eLabeling regulation 2021/2226 

The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented by Implementing Regulation (EU) 2021/2226, the successor to Commission Regulation (EU) 207/2012.

Requirements for the use of electronic instructions for use as per regulation (EU) 2021/2226 

According to Implementing Regulation (EU) 2021/2226, instructions for use may be provided electronically (eIFU) instead of on paper if certain conditions are met:

1. The device should fall into a specific class, as mentioned below:
   • Implantable and active implantable medical devices and their accessories
   • Fixed installed medical devices and their accessories
   • Medical devices and their accessories fitted with a built-in system visually displaying the instructions for use (e.g., ultrasound equipment)
2. The devices and accessories are intended for exclusive use by professional users
3. The use by other  people is not reasonably foreseeable
4. For software, manufacturers may provide eIFUs within the software itself.

Manufacturers of Medical devices that provide instructions for use in electronic form to users instead of in paper form shall undertake a documented risk assessment which shall cover at least the following elements:

• Knowledge and experience of the intended users in particular regarding the use of the device and user needs;
• Characteristics of the environment in which the device will be used;
• knowledge and experience of the intended user of the hardware and software needed to display the instructions for use in electronic form;
• Access of the user to the reasonably foreseeable electronic resources needed at the time of use;
• Performance of safeguards to ensure that the electronic data and content are protected from tampering;
• Safety and backup mechanisms in the event of a hardware or software fault, particularly if the instructions for use in electronic form are integrated within the device;
• Foreseeable medical emergency situations requiring the provision of information in paper form;
• Impact caused by the temporary unavailability of the specific website, of the internet in general, or of their access in the healthcare institution, as well as the safety measures available to cope with such a situation;
• Evaluation of the period within which the instructions for use shall be provided in paper form at the user’s request;
• Assessment of the website’s compatibility with displaying the electronic instructions for use with different devices that could be used to display those instructions;
• Management of different versions of the instructions for use, where applicable

Factors to consider when switching to an electronic IFU for your medical device

1. Risk assessment

eIFU must maintain or improve the level of safety compared to providing a paper IFU. Your risk assessment needs to examine this carefully. For instance, if your device is sometimes used by nurses or doctors in rural locations where the internet may be spotty, what additional risks might that present? You will need to update your risk management procedures and forms to account for this.

2. Product packaging

The location of the eIFU must be indicated on the packaging for each unit or, in the case of fixed devices, on the device itself. For obvious reasons, you cannot simply place PDFs of your IFU on your website and assume professional users will know to look there. The Regulation makes it clear that your packaging must clearly specify that the IFU is in electronic format and where it can be found. Except for software and devices with screens, the IFU may reside on a website, and its location may be communicated via a website URL or QR code. If you choose the latter, make sure you document the pros and cons of using QR codes in your risk assessment and update your labeling work instructions as needed.

3. Validation

Ensure the user’s access is precise by having accurate product data in real-time and a solution for delivering the information in the user’s preferred language.

4. Method of delivery

If you make software as a medical device (SaMD) or a device with a larger display screen, the method of delivery may be the device itself. For all other devices, device manufacturers will most likely deliver IFUs via their website. This fulfills a key requirement that the information be provided in a universally available format (thumb drives and DVDs are no longer universal). The preamble of the new eIFU regulation says, “To ensure unconditional access to the instructions for use in electronic form and to facilitate the communication of updates, those instructions should be available on the website of the manufacturer in an official language of the Union determined by the Member State in which the device is made available to the user or patient.” This does not mean you cannot deliver your eIFU on a private YouTube channel, for example.

5. Paper version

There are professionals out there who prefer paper-based instructions, or (it is true) might not have reliable internet access. It is EU law to have paper IFUs, with the exception of some devices. If a paper-based option is required, you are obligated to provide a paper version within seven calendar days of the request at no cost. In cases where video or animation is not used, the eIFU may simply be a printed copy of the PDF you maintain online. Make sure to update your labeling SOP with this requirement.

6. Online security

Making your IFU available online is easy. Ensuring that it does not accidentally get removed or replaced is not possible. You will need to put procedures in place to ensure that your sales and marketing departments do not change the URL, delete old versions, or otherwise change the document. You should really think of the master IFU web page(s) as controlled documents, not just the IFU itself.

7. Archival procedures

For devices without a defined expiration date, your IFU needs to be maintained for 15 years after the last device has been placed on the market. For devices with an expiration date, this changes to 10 years. You also need to have a system for indicating when changes have been made (change control) and a way to inform each user if the change was made for safety reasons. Finally, all historical versions of the IFU must be made available on the website.

8. Privacy policy

Europe has one of the strictest online privacy laws in the world, known simply as the GDPR (General Data Protection Regulation 2016/679). If you will be asking the user to provide their name and/or email, or if your website has cookies enabled (most do), you will need to make sure you are following the GDPR.

Advantages of eIFU over paper-based instructions:

• Enhanced accessibility: considering the high internet coverage, electronic instructions can be accessed digitally and consulted anywhere, providing easier search and navigation and greater flexibility.
• Real-time updates: eIFU allows for immediate updates and revisions, ensuring that users always have the latest information about the product they are using. This is crucial for patient safety and optimal device utilization.
• User-friendly interfaces: Electronic formats enable the incorporation of multimedia elements, such as videos and interactive features, enhancing the clarity and effectiveness of instructions.
• Increased efficiency in MDR implementation: electronic formats facilitate the inclusion of multiple languages and therefore contribute to reducing the risk of shortages of medical devices and improving the overall availability of these devices, especially in a multilingual context like the European Union.
• Cost efficiency: Over time, the implementation of eIFU can lead to cost savings for both manufacturers and healthcare institutions, as the need for printing, distribution, storage, and waste management of paper IFU is significantly reduced.
• Environmentally sustainable: The transition to eIFU aligns with broader efforts to reduce paper usage, contributing to environmental sustainability and supporting the EU Green Deal.

Going forward, manufacturers seeking to sell their products in the European market must comply with the EU eIFU regulations. Adhering to these regulations will provide greater flexibility and reduce the risk of product recalls related to IFUs. If you are in the process of updating your device labels and preparing eIFUs, feel free to contact DDi for expert assistance.

• Enabling quick identification of equipment affected by field safety corrective actions, failures, recalls, and major adverse events
• Using distribution records to support the identification of medical device
• Reducing medical errors
• Facilitating medical device data capture

Note:

• All class B, C or D medical devices including in vitro diagnostics (IVDs) are required to be registered with HSA on the SMDR (Singapore Medical Device Register) prior to their placement on the Singapore market.
• UDI implementation for all Class A General medical devices and IVDs may be done on a voluntary basis. The Class A medical devices are required to be listed on the Class A medical device database.
• UDIs will not be required for medical devices for clinical research, investigational testing or clinical trial and custom-made medical devices.
• Medical devices authorised for supply via Special Access Routes (GN26, GN27, GN29) are required to comply with UDI requirement on a risk-calibrated approach.

Unless otherwise stated, medical devices that are delivered in Singapore after the relevant compliance date based on the risk class are required to comply with the UDI requirement.

Transitional period to meet each implementation phase’s requirements

As of the relevant UDI compliance dates, all medical devices imported into Singapore must bear the UDI on the label. Companies will, however, have a further six months after the compliance date to deplete any medical devices that they may have imported before the compliance date and that are still in their current supply chain. For instance, starting on November 1, 2022, all medical equipment imported into Singapore must comply with the UDI requirements. Before 1 May 2023, all local inventories of these medical devices that were previously imported before 1 November 2022 should be delivered. All medical device dealers such as registrants, importers, wholesalers and manufacturers of phase 1 must be UDI compliant as of May 1, 2023.

Considerations for Singapore registrants already compliant to US, EU UDI rules

For medical devices marketed in the EU or the USA, UDIs used on the labels for those markets will be recognized as-is for a similar labeled use in Singapore.

Product owners should contact the issuing agency chosen by HSA Singapore, to activate UDI on any devices that are not sold in the EU or the USA.

How DDi will help

• DDi provides support in establishing a UDI strategy for the entire product line that complies with Singapore UDI requirements.
• DDi ensures 100% UDI approach for full suite of products and regulatory compliance.

Learn more about UDI strategy and ensuring regulatory compliance.