Label and artwork management in medical device companies are still seen as an afterthought and therefore, there is not enough concentration as well as investment in this area. However, with new updates such as traceability (UDI) and e-labeling, companies are compelled to invest time and money to be compliant on the regulations required.

One such update is the e-labeling requirement. Health authorities are ensuring e-labeling adherence from marketing authorization holders for their region. For instance, all medical device manufacturers in the European Union have to publish the user information, which is available in labels, technical manuals and instructions of use, on the manufacturer’s website. This is in requirement with the Section 23.1 of Annex I (Chapter III) of the MDR (EU) 745/2017 and section 20.1 of Annex I (Chapter III) of In-vitro Diagnostic MDR (EU) 746/2017. This states that information related to the device needs to be published in electronic form.

There is still heavy dependency on paper-based instruction manuals provided along with the device. Hence, regulatory bodies are ensuring that information pertaining to use of the device is available anywhere and everywhere with the implementation of e-labeling. There may be many reasons with printed copies fading with time, availability of hard copies at the time of use, storing capabilities of the user, etc., implying that paper-based systems are resource intensive.  In addition, regulatory bodies want to reduce the carbon footprint which will help companies to reduce waste and country-based printing cost.

E-labeling is gaining favor with the regulatory bodies and emphasizing on publishing electronic content. All Instructions for Use (IFUs) and Direction for Use (DFUs) are required to be available in electronic forms and all device manufactures must comply with the regulations. All major companies have already started working towards this requirement.

What are the current challenges?

• Content is available in PDF form meant for printing and then uploaded on the website as an electronic file. This may create readability issues as PDFs are not web pages.
• Artwork studio competency to handle such changes on a quick note. Generally, printed labels (IDFs and DFUs) and website content is managed by different teams in many organizations.
• Proofreading of documents and their versions is another challenge as the documents run anywhere between 15 to 150 pages.
• Print version or PDFs have long scrolling content with all languages available in one single file, making it cumbersome for the user to browse. Separating content from common file and creating documents for each language and their corresponding webpage. 

What is required for e-labeling?

• Content is required to be available in all languages where the device is being marketed, which fuels the need for scientific translators.
• Industry standard artwork studio which has the ability to create both print as well as e-IFUs/e-DFUs.
• Creation of QR codes for scanning by users and their availability across all channels, print as well as digital media.
• Ensuring content is consistent across print and electronic forms and deploying of electronic proofreading tool(s) which can compare content web and print version content at the same time. 

This requirement will be a part of supply chain requirement, and the right partner can assist you qualitatively and quantitatively and at the right cost, without impacting the current operations.

Key criteria for the right partner for e-labeling includes:

• Availability of all technology related requirements.
• Industry standard artwork studio for creation of print-based labels as well as e-leaflets.
• Electronic proofreading for documents and version comparisons and making sure quality is not compromised in either platform.
• Scientific language translation for any given country.