Regulation of medical devices and companion diagnostics

Pharmaceutical Technology Europe

Volumn 27, Issue 8, 2015, Pages 6-8

  Milmo, Sean ^a  

^a NONE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CERTIFICATION; DEVICE APPROVAL; DIAGNOSTIC EQUIPMENT; DIAGNOSTIC TEST; EUROPE; EUROPEAN MEDICINES AGENCY; HUMAN; IN VITRO DIAGNOSTIC TEST; LAW; MEDICAL DEVICE; MEDICAL DEVICE REGULATION; PERSONALIZED MEDICINE; POINT OF CARE TESTING; SENSITIVITY AND SPECIFICITY; SHORT SURVEY; TOTAL QUALITY MANAGEMENT;

EID: 84938282602     PISSN: 01646826     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (9)

1. EC proposed regulation 2012/0266, Medical Devices (Brussels, September 2012).
2. EC proposed regulation 2012/0267, In Vitro Diagnostic Medical Devices (Brussels, September 2012).
3. EC Directive 1990/385/EEC, Active Implantable Medical Devices (Brussels, June 1990).
4. EC Directive 1993/42/EEC, Medical Devices (Brussels, June 1993).
5. EC Directive 1998/79/EC, In-Vitro Diagnostic Medical Devices (Brussels, October 1998).
6. UK House of Commons, Science and Technology Committee, "Regulation of medical implants in the EU and UK," Fifth Report of Session 2012-13, 17 October 2012.
7. European Parliament, "Text tabled of amendments with explanatory statement on proposed regulation on in vitro diagnostic medical devices," AT-0327/2013 (Brussels, October 2013).
8. European Diagnostic Manufacturers Association (EDMA), "A Need for Separate Legislation," EDMA Analysis of Proposed Regulation on in vitro diagnostic medical devices www. edma-ivd.be/uploads/PositionPapers/EDMA-2013-22-03-PP-FINAL.pdf, accessed 15 July 2015.
9. S.K. Byron et al., Clin Cancer Res 20 (6) 1469-1476 (2014).