device for self-testing
as defined in Regulation (EU) 2017/746 of the European Parliament and of the Council of…, Article 2, point (5) (Definitions)
(5)
‘device for self-testing’ means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services;
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Also defined in
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical… 31998L0079, Article 1(2), point (d)
any device intended by the manufacturer to be able to be used by lay persons in a home environment;