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Ensuring medical devices are safe and efficient for patients
This summary has been archived and will not be updated. See 'Ensuring the safety and performance of medical devices' for an updated information about the subject.
Directive 93/42/EEC concerning medical devices
It has applied since 29 June 1993 and had to become law in the EU countries by 1 July 1994. It will be repealed as from 26 May 2021.
It does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means.
The complete definition of the term ‘medical device’ is laid down in Article 1(2)(a) of Directive 93/42/EEC.
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, pp. 1-43)
Successive amendments to Directive 93/42/EEC have been incorporated into the original text. This consolidated version is of documentary value only.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, pp. 1-175)
See consolidated version.
Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, pp. 8-19)
See consolidated version.
Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (OJ L 253, 25.9.2013, pp. 27-35)
Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, pp. 3-12)
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72, 10.3.2012, pp. 28-31)
Commission Directive 2005/50/EC of 11 August 2005 on the reclassification of hip, knee and shoulder joint replacements in the framework of Council Directive 93/42/EEC concerning medical devices (OJ L 210, 12.8.2005, pp. 41-43)
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices (OJ L 28, 4.2.2003, pp. 43-44)
Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, pp. 17-36)
See consolidated version.
last update 01.02.2021