SME Chamber

Importers of in-vitro diagnostic medical devices

11 August 2011

It has been brought to our attention that some local importers and distributors are offering for sale in-vitro diagnostic kits and reagents that, although being CE-marked in accordance with Legal Notice 61 of 2002, they are labelled by their own manufacturer as “Not for diagnostic use”, “For Research Purposes only” or other similar statements implying that the products cannot be used for diagnostic purposes. This includes statements given on promotional material.

Such statements coming from the manufacturers themselves must be fully complied with and thus such products cannot be offered for use for diagnostic purposes. Users are being advised not to use products bearing warnings such as the above for diagnosis. It is the legal responsibility of the economic operators, not users, to ensure that only safe and legally compliant devices are placed on the market when these are used in accordance with their intended purpose.

Should you require any clarifications on the subject please do not hesitate to contact us. Mr. David Pulis on or 2395 2000.

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