1. European Council (1993) Directive 93/42/EEC of 14 June 1993 concerning medical devices.
2. European Council (1990) Directive 90/385/EEC of 20 June 1990 on active implantable medical devices.
3. European Council (1998) Directive 98/79/EC of 27 October 1998 on in vitro diagnostic medical devices.
4. FDA CDRH Overview of device regulations.
http://www.fda.gov/cdrh/devadvice/overview.html
5. Global Harmonization Task Force.
http://www.ghtf.org/index.html