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Regulation (EU) 2017/746 of the European Parliament and of the CouncilShow full title

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)

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11.1.Devices and their manufacturing processes shall be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the user or, where applicable, other persons. The design shall:
(a)

allow easy and safe handling;

(b)

reduce as far as possible any microbial leakage from the device and/or microbial exposure during use;

and, where necessary

(c)

prevent microbial contamination of the device during use and, in the case of specimen receptacles, the risk of contamination of the specimen.

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