This document is an excerpt from the EUR-Lex website
Ensuring medical devices are safe for patients
Ensuring medical devices are safe for patients
Ensuring medical devices are safe for patients
Ensuring medical devices are safe for patients
SUMMARY
The aim of this directive is to ensure a high level of protection for human health and safety, smooth operation of the single market and to achieve the results for which the devices are intended.
WHAT DOES THE DIRECTIVE DO?
It harmonises national legislation on medical devices*. This ensures universally high safety standards for patients, giving the public confidence in the system. It enables the products to be used in any European Union country.
KEY POINTS
KEY TERM
*Medical device: appliance, including the necessary software,
BACKGROUND
ACT
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
REFERENCES
Act |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Directive 93/42/EEC |
1.8.1993 |
1.7.1994 |
Amending act(s) |
Entry into force |
Deadline for transposition in the Member States |
Official Journal |
Directive 98/79/EC |
7.12.1998 |
7.12.1999 |
|
Directive 2000/70/EC |
13.12.2000 |
13.12.2001 |
|
Directive 2001/104/EC |
10.1.2002 |
13.12.2001 |
|
Regulation (EC) No 1882/2003 |
20.11.2003 |
- |
|
Directive 2007/47/EC |
11.10.2007 |
21.12.2007 |
Successive amendments and corrections to Directive 93/42/EEC have been incorporated into the basic text. This consolidated version is for information only.
RELATED ACTS
Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices (OJ L 72 of 10.3.2012, pp. 28-31)
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 of 9.8.2012, pp. 3-12)
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 of 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 of 4.2.2003, pp. 43-44)
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 (OJ L 105 of 26.4.2003, pp. 18-23).
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 of 25.9.2013, pp. 27-35).
last update 28.05.2020