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Conducting Medical Device Trials in the EU

Informa Healthcare
July 1, 2007
162 Pages - SKU: IFHC1693904

Abstract Table of Contents Search inside this report Related Reports

"Introducing an easy way to construct effective clinical trials for medical devices and ensure a quick product approval.

Tackle European laws and regulations and prepare successful clinical trials with this new report. Conducting Medical Device Clinical Trials in the EU will guide you through all the stages of the trial - from preparation to capitalising on the results-highlighting potential pitfalls along the way.

This report helps you to:

Learn how to construct efficient and effective clinical trials to ensure speedy product approval
Understand the different requirements of each country to maximise your chances of success in the key markets
Receive practical tips from the report, providing you with a more cost-effective and time saving alternative to expensive regulatory consultants
Avoid the costly pitfalls of an incomplete clinical trials (investigations) strategy.

CHAPTER 1 REGULATIONS
CHAPTER 2 THE MEDICAL DEVICES DIRECTIVE(DIRECTIVE 93/42/EEC)
CHAPTER 3 THE ACTIVE IMPLANTABLE MEDICAL DEVICES DIRECTIVE(DIRECTIVE 90/385/EEC)
CHAPTER 4 THE DIRECTIVE ON MEDICINAL PRODUCTS FOR HUMAN USE (DIRECTIVE 2001/83/EC)
CHAPTER 5 THE CLINICAL TRIALS DIRECTIVE(DIRECTIVE 2001/20/EC)
CHAPTER 6 STANDARDS
CHAPTER 7 THE DECLARATION OF HELSINKI
CHAPTER 8 GUIDELINES
CHAPTER 9 MAJOR REIMBURSEMENT SYSTEMS
CHAPTER 10 PRE-CLINICAL TRIAL CONSIDERATIONS FOR REIMBURSEMENT
CHAPTER 11 CLINICAL TRIAL STRUCTURE FOR REIMBURSEMENT
CHAPTER 12 REGULATIONS GOVERNING CLASSIFICATION
CHAPTER 13 PRACTICALITIES OF CLASSIFICATION
CHAPTER 14 ASSOCIATED APPROVAL PROCEDURES WITH CLASS OF DEVICE
CHAPTER 15 RISK ANALYSIS
CHAPTER 16 ROUTES TO PROVING CONFORMITY ACCORDING TO CLASS
CHAPTER 17 A REVIEW OF REQUIREMENTS AND PROCESSES
CHAPTER 18 THE LITERATURE ROUTE
CHAPTER 19 USING THE LITERATURE REVIEW
CHAPTER 20 TAKING THE CLINICAL TRIAL ROUTE
CHAPTER 21 OVERVIEW OF THE PLANNING PHASE
CHAPTER 22 THE CLINICAL INVESTIGATION TEAM
CHAPTER 23 THE PREPARATION OF THE STUDY DESIGN
CHAPTER 24 PLANNING THE BUDGET
CHAPTER 25 THE CLINICAL INVESTIGATION PLAN
CHAPTER 26 MANAGERIAL APPROVAL
CHAPTER 27 OVERVIEW OF THE PREPARATORY PHASE
CHAPTER 28 PREPARING THE DOCUMENTATION
CHAPTER 29 LABELLING AND INSTRUCTIONS FOR USE
CHAPTER 30 INSURANCE
CHAPTER 31 TRAINING THE INVESTIGATORS
CHAPTER 32 OBTAINING ETHICS COMMITTEE APPROVAL
CHAPTER 33 OBTAINING REGULATORY APPROVAL FOR A CLINICAL INVESTIGATION
CHAPTER 34 OVERVIEW OF THE IMPLEMENTATION PHASE
CHAPTER 35 RESOURCE ALLOCATION
CHAPTER 36 SUBJECT RECRUITMENT
CHAPTER 37 MONITORING
CHAPTER 38 MONITORING CASE STUDIES OVERVIEW OF THE CLOSING PHASE
CHAPTER 39 INITIAL PROCESSES
CHAPTER 40 CLINICAL STUDY REPORT
CHAPTER 42 COUNTRY SPECIFICS: AUSTRIA; BELGIUM; DENMARK; FINLAND; FRANCE; GERMANY; IRELAND; ITALY; THE NETHERLANDS; NORWAY; SPAIN; SWITZERLAND; THE UK
CHAPTER 43 IS A CLINICAL INVESTIGATION REQUIRED?
CHAPTER 44 THE MARKET
CHAPTER 45 FROM DEVELOPMENT TO MARKET
CHAPTER 46 USING THE INFORMATION GAINED FROM A CLINICAL INVESTIGATION

Conducting Medical Device Trials in the EU

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