Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- No longer in force
- CELEX number: 31993L0042
- Official Journal: JOL_1993_169_R_0001_004
- Form: Directive
- Procedure number: 1991/0353(SYN), 1991/0353/SYN
- Languages:
- bg
- cs
- da
- de
- el
- en
- et
- fi
- fr
- hr
- hu
- it
- lv
- lt
- mt
- nl
- pl
- pt
- ro
- sk
- sl
- es
- sv
Dates
Date of document: - June 14, 1993
- July 12, 1993
- June 29, 1993
- Takes effect - Date notif.
- July 1, 1994
- At the latest Adoption See Art 22
- January 1, 1995
- Application See Art 22
- May 25, 2021
- Partial end of validity See 32017R0745 Art. 122 And 32020R0561 Art. 1.7
Modified by
Corrected by:
- November 26, 1997 - 31993L0042R(01)
- March 10, 1999 - 31993L0042R(02)
- May 19, 1999 - 31993L0042R(03)
- March 14, 2001 - 31993L0042R(04)
Modified by:
- Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human blood or human plasma - detail
- Directive 2001/104/EC of the European Parliament and of the Council of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices (Text with EEA relevance) - detail
- Regulation (EC) No 1882/2003 of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty - detail
- Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices - detail
- Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance) - detail
All documents based on this document:
- 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 (Text with EEA relevance)
- Commission Directive 2003/32/EC of 23 April 2003 introducing detailed specifications as regards the requirements laid down in Council Directive 93/42/EEC with respect to medical devices manufactured utilising tissues of animal origin (Text with EEA relevance)
- 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 (Text with EEA relevance)
- Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices Text with EEA relevance
- 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 Text with EEA relevance
- 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 Text with EEA relevance
- Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies (Text with EEA relevance)
Modifies
Modifies:
- Council Directive 84/539/EEC of 17 September 1984 on the approximation of the laws of the Member States relating to electro-medical equipment used in human or veterinary medicine
- 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
Affected by case
- Judgment of the Court (Second Chamber) of 19 November 2009. Kemikalieinspektionen v Nordiska Dental AB. Reference for a preliminary ruling: Svea Hovrätt - Sweden. Reference for a preliminary ruling - Directive 93/42/EEC - Medical devices - Prohibition on the exportation of dental amalgam containing mercury and bearing the ‘CE’ conformity marking - Protection of health and the environment. Case C-288/08.
- A04P1
- A17
- Judgment of the Court (Sixth Chamber) of 24 November 2016. Lohmann & Rauscher International GmbH & Co. KG v BIOS Medical Services GmbH. Request for a preliminary ruling from the Oberlandesgericht Düsseldorf. Reference for a preliminary ruling — Approximation of laws — Directive 93/42/EEC — Medical devices — Class I device (sterile wound dressings) which has been the subject of a conformity assessment procedure by the manufacturer — Parallel imports — Addition to the labelling of information relating to the importer — Supplementary conformity assessment procedure. Case C-662/15.
- A11
- A01P2LF
- Case C-489/06: Judgment of the Court (Fourth Chamber) of 19 March 2009 — Commission of the European Communities v Hellenic Republic (Failure of a Member State to fulfil obligations — Directives 93/36/EEC and 93/42/EEC — Public contracts — Procedures for the award of public supply contracts — Hospital supplies)
- {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 17
- {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 18
- Judgment of the Court (Ninth Chamber) of 25 October 2018. Proceedings brought by Boston Scientific Ltd. Reference for a preliminary ruling — Intellectual and industrial property — Supplementary protection certificate for medicinal products — Regulation (EC) No 469/2009 — Scope — Medical device incorporating as an integral part a substance which, used separately, may be considered to be a medicinal product — Directive 93/42/EEC — Article 1(4) — Concept of ‘administrative authorisation procedure’. Case C-527/17.
- A01P4
- Case C-288/08: Judgment of the Court (Second Chamber) of 19 November 2009 (reference for a preliminary ruling from the Svea Hovrätt (Sweden)) — Kemikalieinspektionen v Nordiska Dental AB (Reference for a preliminary ruling — Directive 93/42/EEC — Medical devices — Prohibition on the exportation of dental amalgam containing mercury and bearing the CE conformity marking — Protection of health and the environment)
- {AR|http://publications.europa.eu/resource/authority/fd_370/AR} 4.1
- Judgment of the Court (Third Chamber), 22 November 2012. Brain Products GmbH v BioSemi VOF and Others. Reference for a preliminary ruling from the Bundesgerichtshof. Reference for a preliminary ruling — Medical devices — Directive 93/42/EEC –Scope — Interpretation of the concept of ‘medical device’ — Product marketed for non-medical use — Investigation of a physiological process — Free movement of goods. Case C‑219/11.
- A01P2LAT3
- Judgment of the Court (Fourth Chamber) of 7 December 2017. Syndicat national de l'industrie des technologies médicales (Snitem) and Philips France v Premier ministre and Ministre des Affaires sociales et de la Santé. Request for a preliminary ruling from the Conseil d'État (France). Reference for a preliminary ruling — Medical devices — Directive 93/42/EEC — Scope — ‘Medical device’ — CE marking — National legislation making drug prescription assistance software subject to a certification procedure laid down by a national authority. Case C-329/16.
- A01P2LA
- A01P1
- Judgment of the Court (Fourth Chamber), 3 October 2013. Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto. Request for a preliminary ruling from the Korkein hallinto-oikeus. Reference for a preliminary ruling — Approximation of laws — Medical devices — Directive 93/42/EEC — Medicinal products for human use — Directive 2001/83/EC — Right of the competent national authority to classify as a medicinal product for human use a product marketed in another Member State as a medical device bearing a CE marking — Applicable procedure. Case C‑109/12.
- A08
- A01P2LA
- A18
- Judgment of the Court (Seventh Chamber) of 19 January 2023. L. GmbH and H. Ltd v Bundesrepublik Deutschland. Reference for a preliminary ruling – Medical devices – Directive 93/42/EEC – Article 1(2)(a) – Definition – Article 1(5)(c) – Scope – Medicinal products for human use – Directive 2001/83/EC – Article 1(2) – Definition of the concept of ‘medicinal product’ – Article 2(2) – Applicable legal framework – Classification as a ‘medical device’ or as a ‘medicinal product’. Joined Cases C-495/21 and C-496/21.
- A01P2LA
- Judgment of the Court (First Chamber) of 14 June 2007. Medipac-Kazantzidis AE v Venizeleio-Pananeio (PE.S.Y. KRITIS). Reference for a preliminary ruling: Symvoulio tis Epikrateias - Greece. Free movement of goods - Directive 93/42/EEC - Hospital purchase of medical devices bearing the CE marking - Protective measures - Public supply contract - Contract falling below the threshold of application of Directive 93/36/EEC - Principle of equal treatment and obligation of transparency. Case C-6/05.
- A08
- A18
- Judgment of the Court (First Chamber) of 16 February 2017. Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH. Request for a preliminary ruling from the Bundesgerichtshof. Reference for a preliminary ruling — Approximation of laws — Industrial policy — Directive 93/42/EEC — Checks on the conformity of medical devices — Notified body appointed by the manufacturer — Obligations of that body — Defective breast implants — Implants manufactured using silicone — Liability of the notified body. Case C-219/15.
- N2PT4.1
- N2PT4.2
- N2PT3.2
- N2PT3.3
- N2PT5.1
- A11P10
- A16P6
- N2PT4.3
- N2
- A11P1
- Case C-662/15: Request for a preliminary ruling from the Oberlandesgericht Düsseldorf (Germany) lodged on 14 December 2015 — Lohmann & Rauscher International GmbH & Co. KG v BIOS Naturprodukte GmbH
- article 1 paragraph 2 point (f)
- article 11
- annex I point 13
- annex VII point 3 Text
- Case C-329/16: Request for a preliminary ruling from the Conseil d’État (Council of State) (France) lodged on 13 June 2016 — Syndicat national de l’industrie des technologies médicales (SNITEM) and Philips France v Premier ministre and Ministre des Affaires sociales et de la Santé
- Case C-496/21: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 August 2021 — H. Ltd. v Federal Republic of Germany
- article 1 paragraph 2 point (a)
- Case C-219/15: Request for a preliminary ruling from the Bundesgerichtshof (Germany) lodged on 13 May 2015 — Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH
- Case C-495/21: Request for a preliminary ruling from the Bundesverwaltungsgericht (Germany) lodged on 12 August 2021 — L. GmbH v Federal Republic of Germany
- article 1 paragraph 2 point (a)
- Case C-527/17: Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 5 September 2017 — LN
- article 1 paragraph 4
- annex I SECTION 7.4 paragraph 1
Legal basis
- TREATY ESTABLISHING THE EUROPEAN ECONOMIC COMMUNITY, PART FIVE - INSTITUTIONS OF THE COMMUNITY, TITLE I - PROVISIONS GOVERNING THE INSTITUTIONS, CHAPTER 1: THE INSTITUTIONS, SECTION 2: THE COUNCIL, ARTICLE 149
- undefined
EuroVoc Vocabulary
- Approximation of laws
- Technical barriers
- Other sectors for approximation of laws
- Quality label
- Medical devices
- Radiation protection
- EC conformity marking
- Harmonisation of standards
- Approximation of laws
- Medical device
- Public health
- Internal market - Principles
- Quality control of industrial products
- Marketing standard
- Market approval
- Health protection