Progressing product compliance via electronic labeling
Today’s product compliance means keeping tabs and keeping up with technology: Read how electronic labeling is well on its way in many regions.
How to be progressive in your product compliance? The answer may lie in your labeling … As electronic labeling (E-labeling) becomes more and more prominent in consumers’ lives, companies will need to keep an eye on how to manage it across the globe. E-labeling has been well applied in various industries to communicate product information within the supply chain, distributors, and consumers. During the COVID-19 pandemic, QR codes have been even closer to consumers daily, like scanning QR codes for a restaurant menu and using QR codes as health identification with vaccine information connected to the national health system. Read on to see where this strategy stands in various regions.
What is E-labeling as part of product compliance?
E-labeling is a common substitute for physical labeling that demonstrates product compliance information when the product, like information communication technology products, has become smaller. Regulators nowadays also favor and encourage electronic format labeling, and industries promote e-labeling initiatives and adopt voluntary e-labeling standards (ISO/IEC 18004: 2015, ISO 22742: 2010, ISO/IEC 22603 Series, or GS1 standards).
Electronic labeling includes a digital display on a device screen, an URL, or a machine-readable code like a linear barcode and two-dimensional barcode (Quick Response “QR” code). E-labeling solves the problem of limited labeling space and provides a real-time update on the product information for consumers. QR code has been popular among information communication technology products, even beyond that.
Some COVID-rapid test kits also offer online videos to instruct users on how to take the sample and complete test kits by themselves at home through a QR code on the product package. The QR code also saves costs on printing paper materials or inserts and preparing multi-language labeling and instruction manuals, reducing paper waste and being more ecologically friendly. Medical devices with higher risk to human health requiring post-market surveillance also apply QR codes as a tool to report adverse events to product manufacturers and local agencies.
EU Electronic Instructions for use and production information
European Union Implementing Regulation (EU) 2021/2226 allows specific types of medical devices to use an electronic format for instructions for use (IFU) instead of a paper format required by the Regulation (EU) 2017/745 Medical Device Regulation (MDR). Manufactures of the following medical devices used by professional users and software falling under the coverage of EU 2017/745 as medical devices can provide electronic IFU for medical devices:
- implantable and active implantable medical devices and their accessories;
- fixed installed medical devices and their accessories; and
- medical devices and their accessories covered by EU 2017/745 and fitted with a built-in system visually displaying the instruction for use.
EU 2021/2226 also requires companies using electronic IFU to carry out a risk assessment to consider, for instance, the knowledge and experience of device users, the environment where the device is applied, safeguard of the electronic data, and web accessibility and availability. Manufacturers must also make paper format IFU available for users without additional cost and provide paper IFU within 7 days after receiving the user’s request.
February 2022, European Medicines Agency further adopts a common standard of electronic product information (ePI) for medicines, including a summary of product characteristics, package leaflet, and labeling. The ePI makes the updated medicine information available for patients, consumers, and healthcare professionals and develops more functions such as adverse events reporting in the EU Member States.
US Unique Devices Identifier (UDI) System
Manufacturers can utilize e-labeling technology to enhance product traceability. US Food and Drug Administration (FDA) issued the Rule on Unique Device Identification (UDI) System, effective on 23 December 2013. 21 CFR § 801.20 requires medical device labels to bear a UDI following the requirements prescribed under § 830 with some exceptions.
UDI is an identifier for health care providers and consumers to identify a medical device by the UDI on the device’s label or package. UDI comprises a device identifier(DI), which include the identifier for a specific version or model of a device, and a production identifier (PI), including the following information:
- lot or batch;
- serial number;
- expiration date;
- manufacturing date; and
- for human cells, tissues, and cellular and tissue-based products (HCT/P), the distinct identification code.
Companies placing labels on medical devices with a UDI must also submit the information to the FDA’s Global Unique Device Identification Database (GUDID). The UDI and GUDID will accelerate data acquisition for health care providers to identify sources and assess more accurate device information. UDI can precisely identify the devices associated with an adverse event and decreases the reporting timeframe of an adverse event to the FDA. In medical device recall, rapid and precise identification of medical devices can also shorten the use and risks of devices on patients.
EU also adopts UDI officially in the EU 2017/745 and EU 2017/746 In Vitro Diagnostic Medical Device Regulation (IVDR).
More jurisdictions have embraced e-labeling applications and technology as an option.
China Chemical Safety Management QR Code
China applies e-labeling technology to the national chemical registration management. More chemical manufacturing or import companies will be subject to providing QR codes related to product safety information in chemical registration and labeling requirements. Companies that import or manufacture hazardous chemicals must register the substance to the National Registration Center for Chemicals (NRCC) under the Measures for Hazardous Chemicals Registration Management. The registration includes:
- classification and labeling information;
- physical and chemical properties;
- major purposes of use;
- hazard characteristics; and
- safety requirements of storage, use, and transport.
According to the State Council’s Work Plan on National Hazardous Chemicals Safety Hazards Centralized Governance, to upgrade and promote the function of NRCC, companies that manufacture or import hazardous chemicals and are responsible for registering the hazardous chemicals must create QR codes for safety data sheets (SDS) and safety labels for each hazardous chemical. Companies must also report, maintain, and update the QR codes, SDS, and safety labeling information on the NRCC.
The Pilot program has been initiated in Guangdong province and rolled out to more regions. Hazardous chemical manufacturers, importers, transporters, and end-users can access chemical classification and emergency response information through the QR codes linked to the SDS and safety labels on the product during chemical leakage, fire, or poisoning accidents.
E-labeling application and technology for your product compliance
More jurisdictions have embraced e-labeling applications and technology as an option for product labeling requirements. E-labeling technology gives consumers convenient access to product information, allows manufacturers or importers to develop the most suitable product information format, and realizes waste reduction and source sustainability.
E-labeling technology can also facilitate the traceability of product distribution. An e-labeling management system can build a database for efficient and time-saving post-market product events like recalls, instruction updates, and user warnings. E-labeling also comes with challenges; we cannot ignore the web accessibility and potential threat of cyber security. Businesses can learn from the e-labeling experience of highly regulated products and evaluate the feasibility of applying e-labeling to a better product compliance strategy.