Erratum: Devices and desires: Industry fights toughening of medical device regulation in Europe (BMJ (Online) (2013) 347, (f6204) DOI:10.1136/bmj.f6204);Devices and desires: Industry fights toughening of medical device regulation in Europe

BMJ (Online)

Volumn 347, Issue 7929, 2013, Pages

  Cohen, Deborah ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DEVICE APPROVAL; DEVICE SAFETY; EUROPE; HEART VALVE PROSTHESIS; MEDICAL DEVICE REGULATION; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; HUMAN; INDUSTRY; LEGISLATION AND JURISPRUDENCE; LEGAL ASPECT;

DEVICE APPROVAL; EUROPE; HUMANS; INDUSTRY; MEDICAL DEVICE LEGISLATION; PATIENT SAFETY;

EID: 84886936427     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f6325     Document Type: Erratum

References (14)

1. Eucomed. Rushed deal leaves patients and jobs in second place. Press release, 25 April 2013. www.eucomed.org/newsroom/117/187/Rushed-deal-leaves- patients-and-jobs-insecond-place?cntnt01template=detail-pr.
2. Cohen D. How a fake hip showed up failings in European device regulation. BMJ 2012;345:e7090.
3. McCulloch P. The EU's system for regulating medical devices. BMJ 2012;345:e7126.
4. Eucomed. Factsheet: financial impact of the revision of the EU medical devices directives on European SMEs and industry. http://eucomed.org/uploads/ Modules/Publications/20130910-financial-impact-mdd-factsheet.pdf
5. MDD: EP proposal will kill device innovation on global scale, commentator says. Med Tech Europe 2013;4 (Oct). www.medtecheurope.org/newsletternews/357/ 86.
6. Boston Consulting Group. Regulation and access to innovative medical technologies. a comparison of the FDA and EU approval processes and their impact on patients and industry. 2012. www.eucomed.org/uploads/Modules/Publications/ 2012-bcg-report-regulation-and-access-to-innovative-medical-technologies.pdf.
7. German National Associations of Statutory Health Insurance Funds. Medical devices: the myths and the truth. 2013.
8. GlobalData. Renal denervation market: impact of major barriers underestimated by industry experts, says Global Data analyst. Press release, 10 October 2013. www.biospace.com/News/renal-denervation-market-impact-of-major- barriers/311423.
9. Van Brabandt H, Neyt M, Hulstaert F. Transcatheter aortic valve implantation (TAVI): risky and costly. BMJ 2012;345:4710.
10. Davis S, Gilbertson E, Goodall S. EU Medical Device Approval Safety Assessment: a comparative analysis of medical device recalls 2005-09. 2011. www.eucomed.org/uploads/Press%20Releases/BCG%20study%20report.pdf.
11. MHRA director of devices concerned with proposed regulations. Healio 2013 Oct. 4. www.healio.com/ophthalmology/regulatory-legislative/news/online/ %7Bf7554262-1c68-4bc1-ad3d-0c5ee2cda6a5%7D/mhra-director-of-devices-concerned- with-proposed-regulations.
12. Hirschler B. Industry fears investment drain as EU weighs new medtech rules. Reuters 2013 Jun. 26. www.reuters.com/article/2013/06/26/europe- medtechidUSL5N0F22UG20130626.
13. Bowis J. Medical devices directive may lead to lower patient safety. 2013. www.theparliament.com/latest-news/article/newsarticle/medical-devices- directive-may-lead-tolower-patient-safety/#.UlKbstLBOSr.
14. Health First Europe. Transparency and governance. www.healthfirsteurope. org/membership/transparency-and-governance.