EU formally recognises 23 new standards
This article was originally published in Clinica
The European Commission has published a list of 23 medical device and diagnostic European standards in the Official Journal of the European Communities which, if met by manufacturers, give a presumption that the manufacturer is in compliance with the relevant requirements of the EU medical device directives. Some are product specific, such as for medical hosiery, while others are horizontal standards affecting large sectors of the industry, such as instructions for use for IVD instruments.
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