1. The European Commission. Medical devices competitiveness—facts and figures (online).
http://ec.europa.eu/health/medical-devices/competitiveness/facts-figures/index_en.htm
. Accessed 28 Aug 2012.
2. U.S. Food and Drug Administration. Medical device registration (online).
http://www.accessdata.fda.gov/premarket/ftparea/Registration.zip
. Accessed 28 Aug 2012.
3. Fraser AG, Daubert JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform: report of a policy conference of the European Society of Cardiology. Eur Heart J. 2011;32(13):1673–86.
4. U.S. Food and Drug Administration. Is the product a medical device? (online).
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm
. Accessed 28 Aug 2012.
5. The European Commission. 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.