The regulation of medical devices and the role of the Medical Devices Agency

British Journal of Clinical Pharmacology, Supplement

Volumn 52, Issue 3, 2001, Pages 229-235

  Jefferys, D B ^a  

^a Medical Devices Agency   (United Kingdom)

Author keywords

Adverse event; Conformity assessment; Device regulation; Medical devices; Medical devices agency; New approach directives; Notified bodies; Vigilance reporting

Indexed keywords

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; EQUIPMENT; EUROPE; HUMAN; MEDICOLEGAL ASPECT; ORGANIZATION AND MANAGEMENT; QUALITY CONTROL; SAFETY; STANDARD; UNITED KINGDOM;

DEVICE APPROVAL; EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; EUROPE; GREAT BRITAIN; HUMANS; LEGISLATION, MEDICAL; QUALITY CONTROL;

EID: 0035461507     PISSN: 02643774     EISSN: None     Source Type: Journal    
DOI: 10.1046/j.0306-5251.2001.01416.x     Document Type: Article

References (4)

1. European Commission. Guide to the implementation of directives based on the Afar Approach and the Global Approach. Luxembourg, Office for Official Publications of the EC. ISBN 92-828-7500-8, 2000.
2. MDA Annual Report and Accounts 1999-2000. The Stationary Office. ISBN 0-10-556874-0, 2000.
3. MDA Business Plan 2000-2001. (available on request from MDA or on the http://\v\vw.medical-devices.gov.uk), 2000.
4. MDA Directives Bulletin No4. Conformity Assessment Procedures (available on request from MDA or on http://\v\v\v.medical-devices.gov.uk, 1999.