Early experience of the european medical devices vigilance system

Australasian Physical and Engineering Sciences in Medicine

Volumn 20, Issue 4, 1997, Pages 203-206

  Randall, H ^a,b  

^a United Kingdom Department of Health   (United Kingdom)

^b Medical Devices Agency   (United Kingdom)

Author keywords

Directives; European Union; Medical Devices; Regulation; Vigilance

Indexed keywords

HEALTH CARE; INTERNATIONAL COOPERATION; INTERNATIONAL LAW;

MEDICAL DEVICES REGULATIONS;

BIOMEDICAL EQUIPMENT;

APPARATUS, EQUIPMENT AND SUPPLIES; ARTICLE; EUROPEAN UNION; HUMAN; MEDICOLEGAL ASPECT; PROSTHESES AND ORTHOSES; RISK MANAGEMENT; SAFETY; STANDARD;

EQUIPMENT AND SUPPLIES; EUROPEAN UNION; HUMANS; LEGISLATION, MEDICAL; PROSTHESES AND IMPLANTS; RISK MANAGEMENT; SAFETY;

EID: 0031283112     PISSN: 01589938     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (4)

1. Directive for Active Implantable Medical Devices 90/385/EEC; Official Journal of the European Communities No L189 20 July 1990
2. Directive for Medical Devices 93/42/EEC; Official Journal of the European Communities No L169 July 1943.
3. Proposal for a European Parliament and Council Directive on in vitro diagnostic medical devices 95/C 172/02. Official Journal of the European Communities.
4. MEDDEV 3/93 Final Draft Guidelines on a Medical Devices Vigilance System, May 1993.