device for self-testing
as defined in Directive 98/79/EC of the European Parliament and of the Council of 27 October…, Article 1(2), point (d)
any device intended by the manufacturer to be able to be used by lay persons in a home environment;
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Also defined in
- Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical… 32017R0746, Article 2, point (5)
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