Labels
What you print on your medical device is not just an eye-pleaser for the customers but is regulated mandatory information!
A label is the display of information about a particular product on its packaging or on itself, which may be in written or printed format. It helps to identify a device and its Manufacturer and serves to communicate information on its intended use, safety and performance.
In case of healthcare products, labels are imperative at both the premarket stage and the postmarket stage. Regulatory Authorities (RAs) require and specify information that the Manufacturers are expected to incorporate on or with the medical devices before and after they are released into the market. Such information includes equipment labels, control labels, user manual, indications for use, shipping labels, maintenance manuals, packaging labels etc. Labels also incorporate markers for traceability which may be substantial in identifying root cause from the entire product development chain in case any product failure/recall occurs.
Manufacturers are supposed to provide the following kinds of labels with their product while releasing it into the market:
Shipping labels
On-device labels
Box labels
Instructions For Use (IFU) or User Manuals
Elexes has designed labels that meet all the above requirements and also comply with applicable guidances and ISO standards like the ISO 15223-1 and EN 1041. Below are some illustrations (Some details have been hidden due to confidentiality reasons):
Aforementioned are the examples of the shipping and box labels of a marrow collection single use sterile device, which was sold in the US market after FDA clearance, and in the European market after ISO 13485 certification and CE Mark. Standardization of labels make them easy to read and understand, and tremendously reduce the translation liability on the Manufacturers, especially when they are planning to launch the device in places like EU and Canada which require labels to be in languages other than English. We identified the correct applicable symbols and accordingly designed the shipping and box labels.
Adequate directions for use must also be mentioned in IFUs, taking into consideration the training and knowledge of the users, especially for Over-the-Counter (OTC) or high risk devices.
After reading this blog, and looking at the illustrations, did you notice any kind of discrepancies in your product label? Don’t worry, it’s never late! Revisit your labeling today by hiring an expert like us!