Infarmed ordered the suspension of the commercialization and the withdrawal from the market of a disposable swab for sampling, from the iclean brandfor improperly bearing the CE marking, as there is no evidence of compliance with European legal requirements.
According to the health authority, at issue is the fact that the manufacturer incorrectly qualifies the product as an “in vitro diagnostic medical device”, when the proper qualification is that of a medical device.
Consequently, there is no evidence that the device has been subject to the respective conformity assessment by a Notified Body evaluating, namely, the aspects related to obtaining, guaranteeing and maintaining sterility conditions”.
It is about “Flocked nasopharyngeal swab” model of the brand “iclean”, from the manufacturer Shenzhen Cleanmo Technology.
According to the National Authority for Medicines and Health Products, the distributor, Vacuette Portugal SA, is “develop the necessary actions for the collection of said medical device”.
Infarmed also says that the entities that have units of this medical device must not make it available/use it.
Source: Observadora
