Medical Device Labeling Today
Over the past decade, regulations requiring, or driving, label changes have been clobbering labeling departments in every industry.
Examples of these continually developing regulatory changes include the below situations:
- In 2012, E-Labeling became available for most of the world’s markets.
- Want the preprinted Instructions for Use (IFU) from your product? Simply add the qualified electronic Instructions for Use (eIFU) website on your label.
- To distribute in South America, Eastern Europe, the Middle East, and the biggest markets in Asia-Pacific, you’ll need Country-Specific Labels.
- Want to distribute in the EU after May 2024? You’ll need to change every label distributed in EU member countries and every label for those countries that used to fall under the Medical Device Directive (MDD).
This ever-changing regulatory environment is not going away. You need a better labeling system. A system that is designed to make label changes easy. Sooner or later, you will need to move information from one labeling system to another, which can be risky and time-consuming. This challenge is present whether you are moving from an old system, moving off a system running on an obsolete platform, or having to move labels from an acquired company into your existing labeling system.
Welcome to Network Partners’ FALCON AI Labeling Tool
You may need to take information out of an image and put it into a database. Some or all of your labels are likely stored as artwork. In the past, this is how labels have always been managed. However, you need to move your label data into a database linked to a format to change your labels quickly. FALCON is unique in that it can take a PDF of a label and parse the information into a spreadsheet. It takes all the text strings (all languages), barcodes, and symbols from ISO 15223 and arranges them in a way that allows you to manage data instead of images.
Once the information is available for manipulation, you can create a database or a loading spreadsheet to link that information to formats in your labeling system. This ability is both great and very scary. Mislabels are already the leading cause of medical device recalls, and you’re about to take all your labels, rip them into tiny pieces and then put them back together. A project like this is not for the faint of heart.
Here comes FALCON again.
Once you’ve linked all your data to formats, FALCON will compare your new labels to the labels in the legacy system. It will compare your database-built labels to your approved labels stored as artwork. FALCON is comparing content, not font size or location on the label, so the labels can look different yet still be comparable by FALCON.
Suppose you’ve made a mistake in formatting and left an element off your label or accidentally modified some information. In that case, FALCON will capture these mistakes and let you fix them before you put these labels into your approval process. Typically, you would do this with people visually verifying every label. This method has always been the way label verification has been conducted. It is slow, painstaking, and ripe for error, but it’s always been the only way to confirm the labels are correct. With FALCON, this process is automated to provide label reviewers a detailed yet easy way to quickly confirm any differences between two labels. This report can be attached to the change notice as the objective evidence that the labels contain the same content or that the difference between the two labels was the intended change.
The Network Partners team is equipped with the knowledge and skills necessary to help you ensure the move to a new labeling system is completed quickly and with no errors. FALCON addresses the two biggest hurdles to moving to a new Global Labeling System (GLS).
Contact a Partner today for a FALCON demonstration to help you manage your labeling issues.