The EU's system for regulating medical devices

BMJ (Online)

Volumn 345, Issue 7880, 2012, Pages

  McCulloch, Peter ^a  

^a JOHN RADCLIFFE HOSPITAL   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; BREAST IMPLANT; CLINICAL EFFECTIVENESS; DEVICE SAFETY; EDITORIAL; EUROPEAN UNION; EVIDENCE BASED MEDICINE; HEALTH CARE SYSTEM; HIP PROSTHESIS; HUMAN; INTEGRATED HEALTH CARE SYSTEM; LAW; LICENSING; MEDICAL DEVICE; METAL IMPLANTATION; PATENT; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL; PUBLIC HEALTH PROBLEM; PUBLIC HEALTH SERVICE; RISK ASSESSMENT;

EQUIPMENT AND SUPPLIES; EUROPE; EUROPEAN UNION; GOVERNMENT REGULATION; HEALTH CARE SECTOR; HUMANS;

EID: 84868013763     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.e7126     Document Type: Editorial

References (7)

1. Cohen D. How a fake hip showed up failings in European device regulation. BMJ 2012; 345:e7090.
2. Cohen D, Billingsley M. Europeans are left to their own devices. BMJ 2011; 342:d2748.
3. Cohen D. How safe are metal-on-metal hip implants? BMJ 2012; 344:e1410.
4. Williams N. The scandal of device regulation in the UK. Lancet 2012; 379:1789-90.
5. European Commission. Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals. COM(2012) 540 final. 2012.
6. Coombes R. Europe's plan to tighten regulation of devices will not reach US standards. BMJ 2012; 345:e6303.
7. McCulloch P, Altman DG, Campbell WB, Flum DR, Glasziou P, Marshall JC, et al. No surgical innovation without evaluation: the IDEAL recommendations. Lancet 2009; 374:1105-12.