Near-patient Testing (NPT) has the fastest-growing market in the IVD segment. Europe is the second-largest market after the United States for NPT. Many companies are trying to launch their NPT products in the European Union (EU), and now with the implementation of In Vitro Diagnostic Medical Device Regulation (EU IVDR) 2017/746, the companies are transitioning towards it.
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
Medical devices need an efficient, effective, and readily available user manual. Over time, paper Instructions for Use (IFU) have been the norm in the medical device industry. However, with the advent of electronic technologies, the paper IFU has been replaced by electronic IFU (eIFU).
Labeling has paramount importance in the medical device industry for ensuring high standards of quality and safety. The labels help educate the end-users or patients about how to use the device, who should use it, how to operate the device safely and what risks it could pose. Therefore, medical device manufacturers must gain a clear understanding and comply with the updated Health Authorities labeling regulations.