In vitro diagnostic medical devices: law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom
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| Format: | Book |
| Language: | English |
| Published: |
Dordrecht <<[u.a.]>>
Kluwer Acad. Publ.
1994
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XI, 117 S. |
| ISBN: | 0792329961 |
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MARC
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| 245 | 1 | 0 | |a In vitro diagnostic medical devices |b law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |c ed.: Bernhard Maassen ... |
| 264 | 1 | |a Dordrecht <<[u.a.]>> |b Kluwer Acad. Publ. |c 1994 | |
| 300 | |a XI, 117 S. | ||
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| 338 | |b nc |2 rdacarrier | ||
| 650 | 4 | |a Recht | |
| 650 | 4 | |a Diagnostic equipment industry -- Law and legislation -- European Economic Community countries | |
| 650 | 4 | |a Prenatal care -- Law and legislation -- European Economic Community countries | |
| 650 | 4 | |a Prenatal diagnosis -- European Economic Community countries | |
| 651 | 4 | |a Europäische Gemeinschaften. Mitgliedsstaaten | |
| 700 | 1 | |a Maassen, Bernhard |4 edt | |
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| _version_ | 1804138191021670400 |
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| adam_text | IN VITRO DIAGNOSTIC MEDICAL DEVICES LAW AND PRACTICE IN FIVE EU MEMBER
STATES: FRANCE, GERMANY, ITALY, SPAIN AND THE UNITED KINGDOM BERNHARD
MAASSEN (HENGELER MUELLER WEITZEL WIRTZ, BRUSSELS) ROBIN WHAITE
(LINKLATERS & PAINES, LONDON) WILHELM KEWENIG (HENGELER MUELLER WEITZEL
WIRTZ, FRANKFURT) GIOVANNI FORLANI (STUDIO LEGALE DE BERTI & JACCHIA,
MILAN) JEREMY MARRIAGE (LINKLATERS & PAINES, PARIS) GONZALO ULLOA
(GOMEZ-ACEBO & POMBO, MADRID) EDITORS: BERNHARD MAASSEN ROBIN WHAITE
KLUWER ACADEMIE PUBLISHERS DORDRECHT / BOSTON / LONDON CONTENTS EDITOR S
NOTE XII PREFACE XIII CHAPTER 1 LAW AND PRACTICE IN FRANCE 1 1. GENERAL
FEATURES 1 1.1. GENERAL REGULATIONS 1 1.1.1. HOMOLOGATION OF MEDICAL OR
DIAGNOSIS TECHNICAL EQUIPMENT 1 1.1.2. WITHDRAWAL OF DANGEROUS PRODUCTS
FROM THE MARKET 2 1.1.3. HEALTH AND SAFETY AT WORK 2 1.2. GOOD
MANUFACTURING PRACTICES 2 1.3. REGULATIONS APPLYING TO LABORATORIES 2
1.3.1. MONOPOLY OF MEDICAL BIOLOGY ANALYSIS 2 1.3.2. AUTHORIZATION AND
CONTROL OF LABORATORIES 3 1.4. REGULATIONS APPLYING TO THE
PHARMACEUTICAL INDUSTRY 3 2. THE DIFFERENT PRODUCT CLASSES AND THEIR
DEFINITIONS: UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 4 2.1.
EXISTENCE OF A DEFINITION OF IVDMD IN NATIONAL LAW 4 2.1.1. REAGENTS 4
2.1.2. TECHNICAL EQUIPMENT 4 2.2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 4
2.2.1. REAGENTS-MAIN DIVISION 4 2.2.2. SPECIFIE REAGENTS . 5 2.2.3.
TECHNICAL INSTRUMENTS 7 3. SUBSTANTIVE REQUIREMENTS RELATING TO THE
PLACING OF IVDMDS ON THE MARKET 7 3.1. OPERATION-RELATED REQUIREMENTS 7
3.1.1. GENERAL OPERATION-RELATED REQUIREMENTS 7 3.1.2. OPERATION-RELATED
REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 8 3.2.
PRODUCT-RELATED REQUIREMENTS 9 3.2.1. PRODUCT-RELATED REQUIREMENTS
RELATED TO QUALITY AND RELIABILITY 9 3.2.2. PRODUCT-RELATED REQUIREMENTS
RELATING TO SAFETY (PROTECTION OF WORKERS AND USERS) 10 3.2.3. PRODUCT
INFORMATION REQUIREMENTS (LABELLING, PACKAGE, LEAFLET; OTHER USER
INFORMATION) 11 VI CONTENTS 4. THE PROCEDURES RELATING TO THE
ESTABLISHMENT OF THE CONFORMITY OF IVDMD BUSINESS OPERATIONS AND OF
IVDMDS AGAINST OPERATION-RELATED AND/OR PRODUCT-RELATED REQUIREMENTS,
TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 12 4.1. ESTABLISHMENT OF
CONFORMITY OF IVDMD BUSINESS OPERATIONS AGAINST OPERATION-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 12 4.1.1.
GENERAL REQUIREMENTS 12 4.1.2. REQUIREMENTS RELATING ONLY TO SPECIFIE
TYPES OF IVDMD 12 4.2. ESTABLISHMENT OF CONFORMITY OF IVDMDS AGAINST
PRODUCT- RELATED AND/OR MANUFACTURE-RELATED REQUIREMENTS, TAKING
EXISTING PRODUCT CLASSES INTO ACCOUNT 13 4.2.1. GENERAL REQUIREMENTS 13
4.2.2. REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 14 5. THE
REQUIREMENTS RELATING TO THE DISTRIBUTION OF IVDMDS TO THE PATIENT/USER,
TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 16 5.1. RESTRICTIONS ON
AVAILABILITY 16 5.1.1. RIAS 16 5.2. RESTRICTIONS ON DISTRIBUTION
CHANNELS 17 5.2.1. IVDMDS FOR LAY USE 17 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 18 5.4.
ADVERTISING RESTRICTIONS 18 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 18 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 18
5.5. REGULATION OF IVDMD WHOLESALERS 19 6. POST-MARKETING CONTROL:
QUALITY CONTROL APPLICABLE TO LABORATORIES 19 CHAPTER 2 LAW AND PRACTICE
IN THE FEDERAL REPUBLIC OF GERMANY 27 1. GENERAL FEATURES OF NATIONAL
REGULATION 27 2. THE DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS.
UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 28 2.1. EXISTENCE OF A
DEFINITION OF IVDMD IN GERMAN LAW 28 2.1.1. REAGENTS 28 2.1.2. IVDMD
TECHNICAL INSTRUMENTS 28 2.1.3. LEGISLATIVE DEVELOPMENTS 30 2.2. THE
DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS. UNDERLYING RATIONALE
FOR SEPARATE LEGAL TREATMENT 30 2.2.1. REAGENTS 31 2.2.2. IVDMD
TECHNICAL INSTRUMENTS 33 CONTENTS VII 3. SUBSTANTIVE REQUIREMENTS
RELATING TO THE PLACING OF IVDMDS ON THE MARKET 34 3.1.
OPERATION-RELATED REQUIREMENTS 34 3.1.1. GENERAL OPERATION-RELATED
REQUIREMENTS 34 3.1.2. OPERATION-RELATED REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 40 3.2. PRODUCT-RELATED REQUIREMENTS 41 3.2.1.
PRODUCT-RELATED REQUIREMENTS RELATING TO QUALITY AND RELIABILITY 41
3.2.2. PRODUCT-RELATED REQUIREMENTS RELATING TO SAFETY (PROTECTION OF
WORKERS AND USERS) 42 3.2.3. PRODUCT INFORMATION REQUIREMENTS
(LABELLING; PACKAGE INSERTS AND OTHER USER INFORMATION) 44 4. THE
PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD
BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 47 4.1. ESTABLISHMENT OF CONFORMITY OF IVDMD BUSINESS OPERATIONS
AGAINST OPERATION-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES
INTO ACCOUNT 47 4.1.1. GENERAL REQUIREMENTS 47 4.1.2. REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 50 4.2. ESTABLISHMENT OF
CONFORMITY OF IVDMDS AGAINST PRODUCT-RELATED AND/OR MANUFACTURE-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 51 4.2.1.
GENERAL REQUIREMENTS 51 4.2.2. REQUIREMENTS RELATING ONLY TO SPECIFIE
TYPES OF IVDMD 52 5. THE REQUIREMENTS RELATING TO THE DISTRIBUTION OF
IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT
55 5.1. RESTRICTIONS ON AVAILABILITY 55 5.1.1. REAGENTS 55 5.1.2.
TECHNICAL INSTRUMENTS 55 5.2. RESTRICTIONS ON DISTRIBUTION CHANNELS 55
5.2.1. REAGENTS 55 5.2.2. TECHNICAL INSTRUMENTS 55 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 55 5.4.
ADVERTISING RESTRICTIONS 56 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 56 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 56
5.5. REGULATION OF IVDMD WHOLESALERS 57 VIII CONTENTS 6. POST-MARKETING
CONTROL: THE REQUIREMENTS RELATING TO THE CONTROL OF THE RELIABILITY OF
IVDMDS IN VIEW OF THEIR USE 57 6.1. REAGENTS 57 6.2. TECHNICAL
INSTRUMENTS 58 CHAPTER 3 LAW AND PRACTICE IN ITALY 59 1. GENERAL
FEATURES OF NATIONAL REGULATION 59 1.1. RADIOACTIVITY HAZARDS 61 1.2.
BIOLOGICAL AND CHEMICAL HAZARDS 61 1.3. CEI STANDARDS 62-25 61 1.4.
ABUSE OF DRUGS 61 1.5. DECREE LAW NO. 390 OF 30 JUNE, 1982 62 2. THE
DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS. UNDERLYING RATIONALE
FOR SEPARATE LEGAL TREATMENT 62 2.1. EXISTENCE OF A DEFINITION OF IVDMD
IN NATIONAL LAW 62 2.2. THE DIFFERENT PRODUCT CLASSES AND THEIR
DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 63 3.
SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF IVDMDS ON THE MARKET
63 3.1. OPERATION-RELATED REQUIREMENTS 63 3.1.1. GENERAL
OPERATION-RELATED REQUIREMENTS 63 3.1.2. OPERATION-RELATED REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 65 3.2. PRODUCT-RELATED
REQUIREMENTS 65 3.2.1. PRODUCT-RELATED REQUIREMENTS RELATING TO QUALITY
AND RELIABILITY 65 3.2.2. PRODUCT-RELATED REQUIREMENTS RELATING TO
SAFETY (PROTECTION OF WORKERS AND USERS) 66 3.2.3. PRODUCT INFORMATION
REQUIREMENTS (LABELLING, PACKAGE, LEAFLETS, OTHER USER INFORMATION) 66
4. THE PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF
IVDMD BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 68 4.1. ESTABLISHMENT OF CONFORMITY OF IVDMD BUSINESS OPERATIONS
AGAINST OPERATION-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES
INTO ACCOUNT 68 4.1.1. GENERAL REQUIREMENTS 68 4.1.2. REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 69 4.2. ESTABLISHMENT OF
CONFORMITY OF IVDMDS AGAINST PRODUCT- RELATED AND/OR MANUFACTURE-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 69 4.2.1.
GENERAL REQUIREMENTS 69 CONTENTS IX 4.2.2. REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 71 5. THE REQUIREMENTS RELATING TO THE
DISTRIBUTION OF IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT
CLASSES INTO ACCOUNT 75 5.1. RESTRICTIONS ON AVAILABILITY 75 5.2.
RESTRICTIONS ON DISTRIBUTION CHANNELS 76 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 76 5.4.
ADVERTISING RESTRICTIONS 76 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 76 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 76
5.5. REGULATION OF IVDMD WHOLESALERS 76 6. POST-MARKETING CONTROL: THE
REQUIREMENTS RELATING TO THE CONTROL OF THE RELIABILITY OF IVDMDS IN
VIEW OF THEIR USE 77 CHAPTER 4 LAW AND PRACTICE IN SPAIN 78 1. GENERAL
FEATURES OF NATIONAL REGULATION 78 2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 80
3. SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF IVDMDS ON THE
MARKET 80 3.1. GENERAL OPERATION-RELATED REQUIREMENTS 80 3.2.
PRODUCT-RELATED REQUIREMENTS 80 3.2.1. PRODUCT-RELATED REQUIREMENTS
RELATING TO QUALITY AND RELIABILITY 80 3.2.2. SAFETY AND PROTECTION OF
WORKERS AND USERS 81 4. PROCEDURES RELATING TO THE ESTABLISHMENT OF THE
CONFORMITY OF IVDMD BUSINESS OPERATIONS AND OF IVDMDS AGAINST
OPERATION-RELATED AND/OR PRODUCT-RELATED REQUIREMENTS 81 4.1. CONFORMITY
WITH OPERATION-RELATED REQUIREMENTS 81 4.1.1. GENERAL 81 4.1.2. SPECIFIE
81 4.2. CONFORMITY WITH PRODUCT-RELATED REQUIREMENTS 81 4.2.1. GENERAL
81 4.2.2. SPECIFIE 81 5. REQUIREMENTS RELATING TO THE DISTRIBUTION OF
IVDMDS TO THE PATIENT/USER 82 6. POST-MARKETING CONTROL 82 CHAPTER 5 LAW
AND PRACTICE IN THE UNITED KINGDOM 84 1. GENERAL FEATURES OF NATIONAL
REGULATION 84 2. DIFFERENT PRODUCT CLASSES 85 2.1. EXISTENCE OF A
DEFINITION OF IVDMD IN UK LAW 85 2.2. DIFFERENT PRODUCT CLASSES - ANY
SEPARATE LEGAL TREATMENT 85 CONTENTS 2.2.1. HIV TESTING KITS AND
SERVICES 85 2.2.2. IVDMDS CONTAINING RADIOACTIVE SUBSTANCES 85 2.2.3.
IVDMDS CONTAINING GENETICALLY MODIFIED ORGANISMS 86 2.2.4. IVDMDS
CONTAINING DANGEROUS SUBSTANCES GENERALLY 86 3. SUBSTANTIVE REQUIREMENTS
RELATING TO THE PLACING OF IVDMDS ON THE MARKET . 86 3.1.
OPERATION-RELATED REQUIREMENTS 86 3.1.1. GENERAL OPERATION-RELATED
REQUIREMENTS 87 3.1.2. OPERATION-RELATED REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 93 3.2. PRODUCT-RELATED REQUIREMENTS 96 3.2.1.
QUALITY AND RELIABILITY 96 3.2.2. SAFETY AND PROTECTION AND WORKERS AND
USERS 97 3.2.3. PRODUCT INFORMATION REQUIREMENTS 97 4. PROCEDURES
RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD BUSINESS
OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS 100 4.1. CONFORMITY WITH OPERATION-RELATED
REQUIREMENTS 100 4.1.1. REQUIREMENTS RELATING ONLY TO GENERAL TYPES OF
IVDMD 100 4.1.2. REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD
100 4.2. CONFORMITY WITH PRODUCT-RELATED REQUIREMENTS 100 4.2.1.
REQUIREMENTS RELATING ONLY TO GENERAL TYPES OF IVDMD 100 4.2.2.
REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 101 5.
REQUIREMENTS RELATING TO THE DISTRIBUTION OF IVDMDS TO THE PATIENT/USER
101 5.1. RESTRICTIONS ON AVAILABILITY 101 5.2. RESTRICTIONS ON
DISTRIBUTION CHANNELS 101 5.3. RESTRICTIONS ON DISTRIBUTION OF SAMPLES
101 5.4. ADVERTISING RESTRICTIONS 101 5.4.1. RESTRICTIONS ON ADVERTISING
TO PROFESSIONAI USERS 102 5.4.2. RESTRICTIONS ON ADVERTISING TO
LAY-USERS 102 5.5. REGULATION OF IVDMD WHOLESALERS 103 6. POST-MARKETING
CONTROL 103 CONTENTS XI CHAPTER 6 SUMMARY OF FINDINGS OF THE NATIONAL
REPORTS 105 1. GENERAL OVERVIEW 105 2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 107
2.1. EXISTENCE OF A DEFINITION OF IVDMD 107 2.2. THE DIFFERENT PRODUCT
CLASSES 107 3. SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF
IVDMDS ON THE MARKET 108 3.1. OPERATION-RELATED REQUIREMENTS 108 3.1.1.
REAGENTS 108 3.1.2. TECHNICAL INSTRUMENTS 109 3.2. PRODUCT-RELATED
REQUIREMENTS 109 3.2.1. GENERAL PRODUCT-RELATED REQUIREMENTS (ESSENTIAL
REQUIREMENTS) 109 3.2.2. SPECIFIE PRODUCT-RELATED REQUIREMENTS 110 4.
PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD
BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 113 4.1. CONFORMITY OF IVDMD BUSINESS OPERATIONS 113 4.2.
ESTABLISHMENT OF PRODUCT CONFORMITY 113 4.2.1. REAGENTS 113 4.2.2.
TECHNICAL INSTRUMENTS 114 5. REQUIREMENTS RELATING TO THE DISTRIBUTION
OF IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 115 5.1. RESTRICTIONS ON AVAILABILITY 115 5.2. RESTRICTIONS ON
DISTRIBUTION CHANNELS 115 5.3. RESTRICTIONS ON DISTRIBUTION OF SAMPLES
115 5.4. ADVERTISING RESTRICTIONS 116 5.4.1. ADVERTISING AIMED AT
PROFESSIONAL USERS 116 5.4.2. ADVERTISING AIMED AT LAY-USERS 116 5.5.
REGULATION OF IVDMD WHOLESALERS 116 6. POST-MARKETING CONTROL:
REQUIREMENTS RELATING TO CONTROL OF RELIABILITY OF IVDMDS IN VIEW OF
THEIR USE 116
|
| adam_txt |
IN VITRO DIAGNOSTIC MEDICAL DEVICES LAW AND PRACTICE IN FIVE EU MEMBER
STATES: FRANCE, GERMANY, ITALY, SPAIN AND THE UNITED KINGDOM BERNHARD
MAASSEN (HENGELER MUELLER WEITZEL WIRTZ, BRUSSELS) ROBIN WHAITE
(LINKLATERS & PAINES, LONDON) WILHELM KEWENIG (HENGELER MUELLER WEITZEL
WIRTZ, FRANKFURT) GIOVANNI FORLANI (STUDIO LEGALE DE BERTI & JACCHIA,
MILAN) JEREMY MARRIAGE (LINKLATERS & PAINES, PARIS) GONZALO ULLOA
(GOMEZ-ACEBO & POMBO, MADRID) EDITORS: BERNHARD MAASSEN ROBIN WHAITE
KLUWER ACADEMIE PUBLISHERS DORDRECHT / BOSTON / LONDON CONTENTS EDITOR'S
NOTE XII PREFACE XIII CHAPTER 1 LAW AND PRACTICE IN FRANCE 1 1. GENERAL
FEATURES 1 1.1. GENERAL REGULATIONS 1 1.1.1. HOMOLOGATION OF MEDICAL OR
DIAGNOSIS TECHNICAL EQUIPMENT 1 1.1.2. WITHDRAWAL OF DANGEROUS PRODUCTS
FROM THE MARKET 2 1.1.3. HEALTH AND SAFETY AT WORK 2 1.2. GOOD
MANUFACTURING PRACTICES 2 1.3. REGULATIONS APPLYING TO LABORATORIES 2
1.3.1. MONOPOLY OF MEDICAL BIOLOGY ANALYSIS 2 1.3.2. AUTHORIZATION AND
CONTROL OF LABORATORIES 3 1.4. REGULATIONS APPLYING TO THE
PHARMACEUTICAL INDUSTRY 3 2. THE DIFFERENT PRODUCT CLASSES AND THEIR
DEFINITIONS: UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 4 2.1.
EXISTENCE OF A DEFINITION OF IVDMD IN NATIONAL LAW 4 2.1.1. REAGENTS 4
2.1.2. TECHNICAL EQUIPMENT 4 2.2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 4
2.2.1. REAGENTS-MAIN DIVISION 4 2.2.2. SPECIFIE REAGENTS . 5 2.2.3.
TECHNICAL INSTRUMENTS 7 3. SUBSTANTIVE REQUIREMENTS RELATING TO THE
PLACING OF IVDMDS ON THE MARKET 7 3.1. OPERATION-RELATED REQUIREMENTS 7
3.1.1. GENERAL OPERATION-RELATED REQUIREMENTS 7 3.1.2. OPERATION-RELATED
REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 8 3.2.
PRODUCT-RELATED REQUIREMENTS 9 3.2.1. PRODUCT-RELATED REQUIREMENTS
RELATED TO QUALITY AND RELIABILITY 9 3.2.2. PRODUCT-RELATED REQUIREMENTS
RELATING TO SAFETY (PROTECTION OF WORKERS AND USERS) 10 3.2.3. PRODUCT
INFORMATION REQUIREMENTS (LABELLING, PACKAGE, LEAFLET; OTHER USER
INFORMATION) 11 VI CONTENTS 4. THE PROCEDURES RELATING TO THE
ESTABLISHMENT OF THE CONFORMITY OF IVDMD BUSINESS OPERATIONS AND OF
IVDMDS AGAINST OPERATION-RELATED AND/OR PRODUCT-RELATED REQUIREMENTS,
TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 12 4.1. ESTABLISHMENT OF
CONFORMITY OF IVDMD BUSINESS OPERATIONS AGAINST OPERATION-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 12 4.1.1.
GENERAL REQUIREMENTS 12 4.1.2. REQUIREMENTS RELATING ONLY TO SPECIFIE
TYPES OF IVDMD 12 4.2. ESTABLISHMENT OF CONFORMITY OF IVDMDS AGAINST
PRODUCT- RELATED AND/OR MANUFACTURE-RELATED REQUIREMENTS, TAKING
EXISTING PRODUCT CLASSES INTO ACCOUNT 13 4.2.1. GENERAL REQUIREMENTS 13
4.2.2. REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 14 5. THE
REQUIREMENTS RELATING TO THE DISTRIBUTION OF IVDMDS TO THE PATIENT/USER,
TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 16 5.1. RESTRICTIONS ON
AVAILABILITY 16 5.1.1. RIAS 16 5.2. RESTRICTIONS ON DISTRIBUTION
CHANNELS 17 5.2.1. IVDMDS FOR LAY USE 17 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 18 5.4.
ADVERTISING RESTRICTIONS 18 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 18 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 18
5.5. REGULATION OF IVDMD WHOLESALERS 19 6. POST-MARKETING CONTROL:
QUALITY CONTROL APPLICABLE TO LABORATORIES 19 CHAPTER 2 LAW AND PRACTICE
IN THE FEDERAL REPUBLIC OF GERMANY 27 1. GENERAL FEATURES OF NATIONAL
REGULATION 27 2. THE DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS.
UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 28 2.1. EXISTENCE OF A
DEFINITION OF IVDMD IN GERMAN LAW 28 2.1.1. REAGENTS 28 2.1.2. IVDMD
TECHNICAL INSTRUMENTS 28 2.1.3. LEGISLATIVE DEVELOPMENTS 30 2.2. THE
DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS. UNDERLYING RATIONALE
FOR SEPARATE LEGAL TREATMENT 30 2.2.1. REAGENTS 31 2.2.2. IVDMD
TECHNICAL INSTRUMENTS 33 CONTENTS VII 3. SUBSTANTIVE REQUIREMENTS
RELATING TO THE PLACING OF IVDMDS ON THE MARKET 34 3.1.
OPERATION-RELATED REQUIREMENTS 34 3.1.1. GENERAL OPERATION-RELATED
REQUIREMENTS 34 3.1.2. OPERATION-RELATED REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 40 3.2. PRODUCT-RELATED REQUIREMENTS 41 3.2.1.
PRODUCT-RELATED REQUIREMENTS RELATING TO QUALITY AND RELIABILITY 41
3.2.2. PRODUCT-RELATED REQUIREMENTS RELATING TO SAFETY (PROTECTION OF
WORKERS AND USERS) 42 3.2.3. PRODUCT INFORMATION REQUIREMENTS
(LABELLING; PACKAGE INSERTS AND OTHER USER INFORMATION) 44 4. THE
PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD
BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 47 4.1. ESTABLISHMENT OF CONFORMITY OF IVDMD BUSINESS OPERATIONS
AGAINST OPERATION-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES
INTO ACCOUNT 47 4.1.1. GENERAL REQUIREMENTS 47 4.1.2. REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 50 4.2. ESTABLISHMENT OF
CONFORMITY OF IVDMDS AGAINST PRODUCT-RELATED AND/OR MANUFACTURE-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 51 4.2.1.
GENERAL REQUIREMENTS 51 4.2.2. REQUIREMENTS RELATING ONLY TO SPECIFIE
TYPES OF IVDMD 52 5. THE REQUIREMENTS RELATING TO THE DISTRIBUTION OF
IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT
55 5.1. RESTRICTIONS ON AVAILABILITY 55 5.1.1. REAGENTS 55 5.1.2.
TECHNICAL INSTRUMENTS 55 5.2. RESTRICTIONS ON DISTRIBUTION CHANNELS 55
5.2.1. REAGENTS 55 5.2.2. TECHNICAL INSTRUMENTS 55 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 55 5.4.
ADVERTISING RESTRICTIONS 56 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 56 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 56
5.5. REGULATION OF IVDMD WHOLESALERS 57 VIII CONTENTS 6. POST-MARKETING
CONTROL: THE REQUIREMENTS RELATING TO THE CONTROL OF THE RELIABILITY OF
IVDMDS IN VIEW OF THEIR USE 57 6.1. REAGENTS 57 6.2. TECHNICAL
INSTRUMENTS 58 CHAPTER 3 LAW AND PRACTICE IN ITALY 59 1. GENERAL
FEATURES OF NATIONAL REGULATION 59 1.1. RADIOACTIVITY HAZARDS 61 1.2.
BIOLOGICAL AND CHEMICAL HAZARDS 61 1.3. CEI STANDARDS 62-25 61 1.4.
ABUSE OF DRUGS 61 1.5. DECREE LAW NO. 390 OF 30 JUNE, 1982 62 2. THE
DIFFERENT PRODUCT CLASSES AND THEIR DEFINITIONS. UNDERLYING RATIONALE
FOR SEPARATE LEGAL TREATMENT 62 2.1. EXISTENCE OF A DEFINITION OF IVDMD
IN NATIONAL LAW 62 2.2. THE DIFFERENT PRODUCT CLASSES AND THEIR
DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 63 3.
SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF IVDMDS ON THE MARKET
63 3.1. OPERATION-RELATED REQUIREMENTS 63 3.1.1. GENERAL
OPERATION-RELATED REQUIREMENTS 63 3.1.2. OPERATION-RELATED REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 65 3.2. PRODUCT-RELATED
REQUIREMENTS 65 3.2.1. PRODUCT-RELATED REQUIREMENTS RELATING TO QUALITY
AND RELIABILITY 65 3.2.2. PRODUCT-RELATED REQUIREMENTS RELATING TO
SAFETY (PROTECTION OF WORKERS AND USERS) 66 3.2.3. PRODUCT INFORMATION
REQUIREMENTS (LABELLING, PACKAGE, LEAFLETS, OTHER USER INFORMATION) 66
4. THE PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF
IVDMD BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 68 4.1. ESTABLISHMENT OF CONFORMITY OF IVDMD BUSINESS OPERATIONS
AGAINST OPERATION-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES
INTO ACCOUNT 68 4.1.1. GENERAL REQUIREMENTS 68 4.1.2. REQUIREMENTS
RELATING ONLY TO SPECIFIE TYPES OF IVDMD 69 4.2. ESTABLISHMENT OF
CONFORMITY OF IVDMDS AGAINST PRODUCT- RELATED AND/OR MANUFACTURE-RELATED
REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO ACCOUNT 69 4.2.1.
GENERAL REQUIREMENTS 69 CONTENTS IX 4.2.2. REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 71 5. THE REQUIREMENTS RELATING TO THE
DISTRIBUTION OF IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT
CLASSES INTO ACCOUNT 75 5.1. RESTRICTIONS ON AVAILABILITY 75 5.2.
RESTRICTIONS ON DISTRIBUTION CHANNELS 76 5.3. RESTRICTIONS ON
DISTRIBUTION OF SAMPLES (COMMERCIAL AND PRIVATE END-USERS) 76 5.4.
ADVERTISING RESTRICTIONS 76 5.4.1. RESTRICTIONS ON ADVERTISING TO
PROFESSIONAL USERS 76 5.4.2. RESTRICTIONS ON ADVERTISING TO LAY-USERS 76
5.5. REGULATION OF IVDMD WHOLESALERS 76 6. POST-MARKETING CONTROL: THE
REQUIREMENTS RELATING TO THE CONTROL OF THE RELIABILITY OF IVDMDS IN
VIEW OF THEIR USE 77 CHAPTER 4 LAW AND PRACTICE IN SPAIN 78 1. GENERAL
FEATURES OF NATIONAL REGULATION 78 2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 80
3. SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF IVDMDS ON THE
MARKET 80 3.1. GENERAL OPERATION-RELATED REQUIREMENTS 80 3.2.
PRODUCT-RELATED REQUIREMENTS 80 3.2.1. PRODUCT-RELATED REQUIREMENTS
RELATING TO QUALITY AND RELIABILITY 80 3.2.2. SAFETY AND PROTECTION OF
WORKERS AND USERS 81 4. PROCEDURES RELATING TO THE ESTABLISHMENT OF THE
CONFORMITY OF IVDMD BUSINESS OPERATIONS AND OF IVDMDS AGAINST
OPERATION-RELATED AND/OR PRODUCT-RELATED REQUIREMENTS 81 4.1. CONFORMITY
WITH OPERATION-RELATED REQUIREMENTS 81 4.1.1. GENERAL 81 4.1.2. SPECIFIE
81 4.2. CONFORMITY WITH PRODUCT-RELATED REQUIREMENTS 81 4.2.1. GENERAL
81 4.2.2. SPECIFIE 81 5. REQUIREMENTS RELATING TO THE DISTRIBUTION OF
IVDMDS TO THE PATIENT/USER 82 6. POST-MARKETING CONTROL 82 CHAPTER 5 LAW
AND PRACTICE IN THE UNITED KINGDOM 84 1. GENERAL FEATURES OF NATIONAL
REGULATION 84 2. DIFFERENT PRODUCT CLASSES 85 2.1. EXISTENCE OF A
DEFINITION OF IVDMD IN UK LAW 85 2.2. DIFFERENT PRODUCT CLASSES - ANY
SEPARATE LEGAL TREATMENT 85 CONTENTS 2.2.1. HIV TESTING KITS AND
SERVICES 85 2.2.2. IVDMDS CONTAINING RADIOACTIVE SUBSTANCES 85 2.2.3.
IVDMDS CONTAINING GENETICALLY MODIFIED ORGANISMS 86 2.2.4. IVDMDS
CONTAINING DANGEROUS SUBSTANCES GENERALLY 86 3. SUBSTANTIVE REQUIREMENTS
RELATING TO THE PLACING OF IVDMDS ON THE MARKET . 86 3.1.
OPERATION-RELATED REQUIREMENTS 86 3.1.1. GENERAL OPERATION-RELATED
REQUIREMENTS 87 3.1.2. OPERATION-RELATED REQUIREMENTS RELATING ONLY TO
SPECIFIE TYPES OF IVDMD 93 3.2. PRODUCT-RELATED REQUIREMENTS 96 3.2.1.
QUALITY AND RELIABILITY 96 3.2.2. SAFETY AND PROTECTION AND WORKERS AND
USERS 97 3.2.3. PRODUCT INFORMATION REQUIREMENTS 97 4. PROCEDURES
RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD BUSINESS
OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS 100 4.1. CONFORMITY WITH OPERATION-RELATED
REQUIREMENTS 100 4.1.1. REQUIREMENTS RELATING ONLY TO GENERAL TYPES OF
IVDMD 100 4.1.2. REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD
100 4.2. CONFORMITY WITH PRODUCT-RELATED REQUIREMENTS 100 4.2.1.
REQUIREMENTS RELATING ONLY TO GENERAL TYPES OF IVDMD 100 4.2.2.
REQUIREMENTS RELATING ONLY TO SPECIFIE TYPES OF IVDMD 101 5.
REQUIREMENTS RELATING TO THE DISTRIBUTION OF IVDMDS TO THE PATIENT/USER
101 5.1. RESTRICTIONS ON AVAILABILITY 101 5.2. RESTRICTIONS ON
DISTRIBUTION CHANNELS 101 5.3. RESTRICTIONS ON DISTRIBUTION OF SAMPLES
101 5.4. ADVERTISING RESTRICTIONS 101 5.4.1. RESTRICTIONS ON ADVERTISING
TO PROFESSIONAI USERS 102 5.4.2. RESTRICTIONS ON ADVERTISING TO
LAY-USERS 102 5.5. REGULATION OF IVDMD WHOLESALERS 103 6. POST-MARKETING
CONTROL 103 CONTENTS XI CHAPTER 6 SUMMARY OF FINDINGS OF THE NATIONAL
REPORTS 105 1. GENERAL OVERVIEW 105 2. THE DIFFERENT PRODUCT CLASSES AND
THEIR DEFINITIONS. UNDERLYING RATIONALE FOR SEPARATE LEGAL TREATMENT 107
2.1. EXISTENCE OF A DEFINITION OF IVDMD 107 2.2. THE DIFFERENT PRODUCT
CLASSES 107 3. SUBSTANTIVE REQUIREMENTS RELATING TO THE PLACING OF
IVDMDS ON THE MARKET 108 3.1. OPERATION-RELATED REQUIREMENTS 108 3.1.1.
REAGENTS 108 3.1.2. TECHNICAL INSTRUMENTS 109 3.2. PRODUCT-RELATED
REQUIREMENTS 109 3.2.1. GENERAL PRODUCT-RELATED REQUIREMENTS (ESSENTIAL
REQUIREMENTS) 109 3.2.2. SPECIFIE PRODUCT-RELATED REQUIREMENTS 110 4.
PROCEDURES RELATING TO THE ESTABLISHMENT OF THE CONFORMITY OF IVDMD
BUSINESS OPERATIONS AND OF IVDMDS AGAINST OPERATION-RELATED AND/OR
PRODUCT-RELATED REQUIREMENTS, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 113 4.1. CONFORMITY OF IVDMD BUSINESS OPERATIONS 113 4.2.
ESTABLISHMENT OF PRODUCT CONFORMITY 113 4.2.1. REAGENTS 113 4.2.2.
TECHNICAL INSTRUMENTS 114 5. REQUIREMENTS RELATING TO THE DISTRIBUTION
OF IVDMDS TO THE PATIENT/USER, TAKING EXISTING PRODUCT CLASSES INTO
ACCOUNT 115 5.1. RESTRICTIONS ON AVAILABILITY 115 5.2. RESTRICTIONS ON
DISTRIBUTION CHANNELS 115 5.3. RESTRICTIONS ON DISTRIBUTION OF SAMPLES
115 5.4. ADVERTISING RESTRICTIONS 116 5.4.1. ADVERTISING AIMED AT
PROFESSIONAL USERS 116 5.4.2. ADVERTISING AIMED AT LAY-USERS 116 5.5.
REGULATION OF IVDMD WHOLESALERS 116 6. POST-MARKETING CONTROL:
REQUIREMENTS RELATING TO CONTROL OF RELIABILITY OF IVDMDS IN VIEW OF
THEIR USE 116 |
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| index_date | 2024-07-02T22:36:57Z |
| indexdate | 2024-07-09T21:24:15Z |
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| spelling | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom ed.: Bernhard Maassen ... Dordrecht <<[u.a.]>> Kluwer Acad. Publ. 1994 XI, 117 S. txt rdacontent n rdamedia nc rdacarrier Recht Diagnostic equipment industry -- Law and legislation -- European Economic Community countries Prenatal care -- Law and legislation -- European Economic Community countries Prenatal diagnosis -- European Economic Community countries Europäische Gemeinschaften. Mitgliedsstaaten Maassen, Bernhard edt GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016860705&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom Recht Diagnostic equipment industry -- Law and legislation -- European Economic Community countries Prenatal care -- Law and legislation -- European Economic Community countries Prenatal diagnosis -- European Economic Community countries |
| title | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |
| title_auth | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |
| title_exact_search | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |
| title_exact_search_txtP | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |
| title_full | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom ed.: Bernhard Maassen ... |
| title_fullStr | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom ed.: Bernhard Maassen ... |
| title_full_unstemmed | In vitro diagnostic medical devices law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom ed.: Bernhard Maassen ... |
| title_short | In vitro diagnostic medical devices |
| title_sort | in vitro diagnostic medical devices law and practice in five eu member states france germany italy spain and the united kingdom |
| title_sub | law and practice in five EU member states: France, Germany, Italy, Spain and the United Kingdom |
| topic | Recht Diagnostic equipment industry -- Law and legislation -- European Economic Community countries Prenatal care -- Law and legislation -- European Economic Community countries Prenatal diagnosis -- European Economic Community countries |
| topic_facet | Recht Diagnostic equipment industry -- Law and legislation -- European Economic Community countries Prenatal care -- Law and legislation -- European Economic Community countries Prenatal diagnosis -- European Economic Community countries Europäische Gemeinschaften. Mitgliedsstaaten |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016860705&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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