Market introduction of innovative high risk medical devices: Towards a recast of the directive concerning medical devices

European Journal of Health Law

Volumn 18, Issue 5, 2011, Pages 477-489

  Vinck, Imgard ^a   Hulstaert, Frank ^a   Van Brabandt, Hans ^b   Neyt, Mattias ^a   Stordeur, Sabine ^a  

^a BELGIAN HEALTH CARE KNOWLEDGE CENTRE KCE   (Belgium)

^b Belgian Center for Evidence Based Medicine   (Belgium)

Author keywords

Device approval; Equipment and supplies; European Union (EU); Legal; Liability; Medical device; Prostheses and implants; United States Food And Drug Administration

Indexed keywords

ARTICLE; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; DEVICE APPROVAL; DEVICE SAFETY; EUROPE; GOVERNMENT REGULATION; HUMAN; LEGAL ASPECT; LEGAL LIABILITY; UNITED STATES;

CLINICAL TRIALS AS TOPIC; DEVICE APPROVAL; EQUIPMENT SAFETY; EUROPE; GOVERNMENT REGULATION; HUMANS; LIABILITY, LEGAL; UNITED STATES;

EID: 80155129000     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180911X598735     Document Type: Article

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