Regulatory aspects of clinical trials for medical devices and in vitro diagnostics;Regulatorische Anforderungen an klinische Prüfungen mit Medizinprodukten und Leistungsbewertungsprüfungen mit In-vitro-Diagnostika

Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Volumn 48, Issue 5, 2005, Pages 556-561

  Schwarz, Joachim A ^a  

^a NONE   (Germany)

Author keywords

Clinical trial; In vitro diagnostics; Medical device; Performance evaluation study

Indexed keywords

ANALYTICAL EQUIPMENT; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; DEVICE; EVALUATION; GERMANY; HUMAN; IN VITRO STUDY; LAW; MEDICAL ETHICS; MEDICAL INSTRUMENTATION; PERFORMANCE; PROFESSIONAL STANDARD;

ANIMALS; CLINICAL TRIALS; DEVICE APPROVAL; DIAGNOSTIC TECHNIQUES AND PROCEDURES; EQUIPMENT AND SUPPLIES; ETHICS COMMITTEES; EUROPE; EVALUATION STUDIES; GERMANY; HUMANS; INFORMED CONSENT; PHYSICIAN-PATIENT RELATIONS; PRACTICE GUIDELINES; RISK ASSESSMENT; TIME FACTORS;

EID: 19444363104     PISSN: 14369990     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00103-005-1036-3     Document Type: Article

References (15)

1. Medical Device Directive - MDD 93/42/EEC (http://www.europa.eu.int/comm/ enterprise/medical_devices/index.htm oder http://www.bvmed.de oder http://www.bfarm.de/de/index.php)
2. Active Implantable Medical Device Directive - AIMDD 90/385/EEC
3. Gesetz über Medizinprodukte (MPG), 2002: (http://www.dimdi.de/germ/ mpg/fr-mpg.htm, http://www.bfarm.de/de/index.php)
4. In Vitro Diagnostic Directive - IVDD 98/79/EC
5. ICH GCP - Good Clinical Practice: Consolidated Guideline (Clinical Trial Protocol and Amendments, Investigator's Brochure, Essential Documents for the Conduct of a clinical trial) (CPMP/ICH/135/95)
6. Kodex Medizinprodukte, hrsg. vom Bundesfachverband Medizinprodukteindustrie e.V. und der Arbeitsgemeinschaft der Spitzenverbänden der Krankenkassen. NJW 24:XXff (1997) (http://www.bvmed.de/text/kodex.htm)
7. Biologische Beurteilung von Medizinprodukten ISO 10993 (http://www.devicelink.com/mddi/archive/98/01/023.html)
8. Blue Book Memorandum ISO-10993, 1995 (http://www.fda.gov/cdrh/ blbkmem.html)
9. ISO 14155, First edition 2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements, - Part 2: Clinical Investigation Plans
10. FDA IDE-Regularien Center for Devices and Radiological Health (CDRH): (http://www.fda.gov/cdrh/), CDRH Device Advice: (http://www.fda.gov/cdrh/ devadvice/index.html), Blue Book Memos - ODE Guidance Memoranda (http://www.fda.gov/cdrh/blbkmem.html)
11. Recommendation NB-MED/2.7/Rec1 Title: Guidance on clinicals. Chapter: 2.7 Clinical investigations, clinical evaluation (http://www.donawa.com/24.pdf)
12. Guidance for Industry and FDA Staff (2004) Premarket assessment of pediatric medical devices (http://www.fda.gov/cdrh/mdufma/guidance/ 1220.pdf)
13. Aktuelle Liste der akkreditierten Ethikkommissionen (http://www.bfarm.de/de/Medizinprodukte/index.php)
14. den Obersten Landesbehörden, zuständige Behörden, Bundeswehr, die mit Anzeigen nach §§ 20 Abs. 6 und 24 Abs. 2 MPG befasst sind (http://www.dimdi.de/de/mpg/recht/index.htm, http://www.bfarm.de/de/Medizinprodukte/klin_ethik/index.php)
15. Contents of a Device Master File (http://www.mdss.com/MDD/ devicemstr.htm; http://www.mdss.com/IVDD/ivddchecklist2.htm, www.mdss.com/MDD/devicemstr.htm)