medical device
as defined in Directive 98/79/EC of the European Parliament and of the Council of 27 October…, Article 1(2), point (a)
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or alleviation of disease, - diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap, - investigation, replacement or modification of the anatomy or of a physiological process, - control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
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Also defined in
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data… 32025R0327, Article 2(1), point (e)
laid down in Article 2, points (1), (12), (14), (22), (36) and (71), respectively, of Regulation (EU) 2017/745 - Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border… 32022R2371, Article 3, point (12)
both a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council, read in conjunction with Article 1(2) and Article 1(6), point (a), of that Regulation, and an in vitro diagnostic medical device as defined in Article 2, point (2)… - Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the… 32022R0123, Article 2, point (e)
a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 or an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746, and includes accessories for such devices within the meaning of Article 2, point (2), of Regulation (EU)… - 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 (1)
‘medical device’ as defined in point (1) of Article 2 of Regulation (EU) 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (1)
any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: — diagnosis, prevention, monitoring, prediction, prognosis… - Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic… 32012L0019, Article 3(1), point (m)
a medical device or accessory within the meaning of, respectively, point (a) or (b) of Article 1(2) of Council Directive 93/42/EEC of 14 June 1993 concerning medical devices which is EEE; - Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of… 32011L0065, Article 3, point (21)
a medical device within the meaning of point (a) of Article 1(2) of Directive 93/42/EEC and which is also EEE - Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’… 32011L0024, Article 3, point (j)
a medical device as defined by Directive 90/385/EEC, Directive 93/42/EEC or Directive 98/79/EC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 31993L0042, Article 1(2), point (a)
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: - diagnosis, prevention, monitoring, treatment or… - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active… 31990L0385, Article 1(2), point (a)
any instrument, apparatus, appliance, material or other article, whether used alone or in combination, together with any accessories or software for its proper functioning, intended by the manufacturer to be used for human beings in the: - diagnosis, prevention, monitoring, treatment or alleviation…