A novel identification system for potentially counterfeit medical devices based on the visual analysis through evaluation sheet .

Background. The counterfeiting of medical devices has been a growing problem for several years, especially since the extension of the internet. Regulatory authorities are responsible, in collaboration with relevant national and international stakeholders, for establishing mechanisms to detect falsified products circulating in their territories and for removing them from the market. Thus it might be useful develop a simple and affordable preliminary screening methods to be used by inspectors to decide in the field whether to collect a sample for further laboratory analysis or not. We here report a new method to compare the physical appearances of suspected samples with those of known genuine products based on the new regulation 2017/745 on medical devices. Methods. According to the new Regulation (EU) 2017/745 on medical devices, we have collected all the requirements regarding the information supplied with the device, including: qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action, the labeling and packaging and the CE marking of conformity. Thanks to these pieces of information, along with those concerning the physical characteristics of the product, permit us to compare the potentially counterfeit medical devices with the known genuine products. Results. We developed a new and quick method to provide evidence that the sample comes from a falsified product. We have designed a table (Table 1) containing a list of questions to ask yourself to compare potentially counterfeit medical device with the known genuine products. The questions include the visual analysis of packaging and the information reported on the package (Does it reflect the appearance of the original form and colour? Is the packaging size the same as the original? Is this system homologous to the original? Do the information on the packaging reflect the appearance of the original colour and form?...), including qualitative and quantitative information (Since it is a substance-based medical device, is the overall qualitative composition of the device reported? Does this match that of its original counterpart?...), the presence and the conformity of CE marking (Is there an EC marking? Is the marking clear, legible and indelible?...) and the physical analysis of the characteristics of the product (Do they all have the same shape if they are tablets/capsules? Do all tablets/capsules have the same size among them and compared to the original? Do all the tablets have the same type of surface coating?...).The questions provide a simple yes or no answer. Conclusions. Visual analysis is an important part of the inspection process in the pharmaceutical industry. Falsified medical devices may be identified from this simple and quick method.