The world's leading automated proofreading software

Help Centre   |   Contact Sales

October 6, 2021

The Schlafender Hase Team

MDR e-Labeling

Ensuring e-IFUs are aligned with your printed Instructions for Use leaflets

The EU Medical Device Regulations (MDR) states any device manufacturer with a website must publish user information in electronic form. Other international jurisdictions already have similar requirements, all of which place new emphasis on e-Labeling as a discipline, which can be defined as the electronic publishing of labeling content, including Instructions for Use (IFU).

As medical device companies make labeling publicly available on their websites, the importance of clear, precise, and consistent content will increase. The ability to produce error-free labeling will thus become a competitive advantage for every medical device manufacturer.

Many companies, including Integra Lifesciences, Johnson & Johnson, Beckton Dickinson and Abbott Vascular, are already publishing their IFUs electronically. Most organizations upload a PDF version of artwork files used to print the insert leaflet. However, there is an issue from the perspective of a user or a patient: some of the folded broadsheet inserts, in multiple languages, are almost illegible online and impossible to print out in a format that can be read within a healthcare setting or on a home printer. There is nothing in published regulations to say this format cannot be used, and companies are obliged to ensure that online versions do not deviate from printed versions, but the MDR regulations does state that the IFUs must be clear, understandable and legible. These same requirements apply to e-Labeling and e-IFUs. Therefore, the online format really should be user friendly and reformatted for web consumption.

To assist companies with this and ensure their labeling content is consistent across both printed and online versions, Schlafender Hase offers TVT (Text Verification Tool®), a proofreading tool that can compare printed formats with web-based versions to verify that they are accurate and compliant from a content perspective, regardless of the layout and format they are presented in.

As regulations change, products are updated, instructions need to be reviewed and errors rectified. These complexities will magnify, thus increasing the risk of discrepancies. TVT will provide a solution for a rolling verification of printed and online content, becoming pivotal to a highly efficient process of continuous compliance.

Interested in knowing more about how TVT will provides solutions for you? Watch our short videos:

Do you want to find out more about how your proofreading life can be easier? Get in touch and we’ll tell you all about it.

Subscribe to our blog

Follow Us

Related Blogs

September 22, 2023

Schlafender Hase Team

The Importance of Braille Inspection on Packaging

September 20, 2023

Schlafender Hase Team

Top Medical Device use document comparison software to proofread labeling. Why aren’t you?

When the subject of proofreading comes up, most think of correcting written text in a document such as a book or a school essay. In the Medical Device industry, however, proofreading is a whole lot more than that. Packaging and labeling can include many elements such as instructions for use, company logo, symbols and numerous other graphics, as well as a variety of different barcodes. Everything has a purpose and must be correct before a device goes to market.

September 18, 2023

Schlafender Hase Team

5 Must-Do Activities in Montreal During RAPS Convergence 2023

Welcome, esteemed professionals attending RAPS Convergence in Montreal! To help you experience the best of what Montreal has to offer, we've compiled a list of five must-do activities during your visit. Get ready to explore the charm and excitement of this captivating Canadian metropolis!