Medical Devices and Medicine-Device Combinations

5. References

• World Health Organization. Definition of the terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’, Global Harmonization Task Force, 2012. Available in Section 2 from: https://apps.who.int/iris/bitstream/handle/10665/255177/9789241512350-eng.pdf (Accessed 3 March 2022).

• European Commission . European Council Directive: Medical Devices. 14 June 1993. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31993L0042 (Accessed 23 February 2022).

• World Health Organization. Medical devices: managing the mismatch, 2010. Available from: http://apps.who.int/iris/bitstream/handle/10665/44407/9789241564045_eng.pdf?sequence=1 (Accessed 3 March 2022).    

• World Health Organization. Medical device regulations: global overview and guiding principles. Geneva, World Health Organization, 2003. Available from: https://apps.who.int/iris/handle/10665/42744 (Accessed 15 June 2022).