IL RUOLO DELL’ISTITUTO SUPERIORE DI SANITA’ COME
ORGANO TECNICO: IL CONTRIBUTO DEL DIPARTIMENTO
DI MALATTIE INFETTIVE, PARASSITARIE, ED
IMMUNOMEDIATE
Dr. Maria Rapicetta
Dirigente di ricerca – DIRETTORE DEL REPARTO EPATITI VIRALI DIP. MIPI
1° CORSO DI AGGIORNAMENTO SUI DISPOSITIVI MEDICI: ASPETTI REGOLATORI E
APPLICATIVI
ROMA, 18-19 MAGGIO 2009
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
RIFERIMENTI NORMATIVI
DPR 13/3/1986, n. 128 – Regolamento di esecuzione delle norme di cui all’art.189 del testo unico delle leggi sanitarie, approvato con regio
decreto 24/7/1934, n. 1265, e successive modificazioni, in materia di produzione e commercio dei presidi medico-chirurgici. G.U. Serie Gen.
n. 98 del 29/4/1986.
DM 3/3/1987, n. 133 - Assoggettamento alla disciplina dei presidi medico-chirurgici dei Kit per la rilevazione di anticorpi anti HIV. G.U.
Serie Gen. n. 80 del 6/4/1987.
DM 12/12/1991 - Assoggettamento dei reagenti per il rivelamento di HBsAg ed anti HCV alla disciplina dei presidi medico-chirurgici. G.U.
Serie Gen. n. 41 del 19/2/1992.
DPR 6/10/1998, n. 392 - Regolamento recante norme per la semplificazione dei procedimenti di autorizzazione alla produzione ed
all’immissione in commercio di presidi medico-chirurgici, a norma dell’art. 20, comma 8, della legge 15/3/1997 n. 59. G.U. Serie Gen. n. 266
del 13/11/1998.
Provvedimento ministeriale 5/2/1999 – Approvazione dei requisiti della domanda e relativa documentazione da presentare ai fini
dell’autorizzazione all’immissione in commercio ed alla variazione di autorizzazioni già concesse per i presidi medico-chirurgici. G.U. Serie
Gen. n. 34 del 11/2/1999.
Circolare ministeriale 30/10/2000, n. 17 – Adeguamento dei livelli di sicurezza trasfusionale in presenza di metodiche atte alle indagini sui
costituenti virali per HCV. G.U. Serie Gen. n. 258 del 4/11/2000.
Circolare ministeriale 19/12/2001, n. 14 – Indicazioni integrative alla Circolare 30/10/2000 n. 17, recante: “Adeguamento dei livelli di
sicurezza trasfusionale in presenza di metodiche atte alle indagini sui costituenti virali per HCV”. G.U. Serie Gen. n. 300 del 28/12/2001.
DL 9/5/2003, n. 103 - Disposizioni urgenti relative alla sindrome respiratoria acuta severa (SARS). G.U. Serie Gen. n. 108 del 12/5/2003.
Direttiva 98/79/CE del Parlamento Europeo e del Consiglio del 27/10/1998 relativa ai dispositivi medico-diagnostici in vitro. G.U. C.E.
n. L.331 del 7/12/1998.
DL 8/9/2000, n. 332 – Attuazione della Dir. 98/79/CE relativa ai dispositivi medico-diagnostici in vitro. G.U. Serie Gen. n. 269 del 17/11/2000.
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
NATIONAL CONTROLS OF HIV AN HEPATITIS
TEST KITS IN EC MEMBER STATES*
EC Member State
National control
authority
licensing control
and/or evaluation
National control
authority batch
release
X
X
Austria
Belgium
Denmark
Finland
France
Germany
Greece
Ireland
Italy
Luxembourg
Netherlands
Portugal
Spain
Sweden
UK
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Monitoring of
kits in use and
other evaluation
systems
None
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
* from CPMP Biotechnology working group
ATTIVITA’ DI CONTROLLO E CONSULENZA DEL DIPARTIMENTO MIPI
DELL’ISS NEL SETTORE DEI KIT DIAGNOSTICI IN VITRO
● Controllo di kit di tipo immunometrico per determinazioni qualitative e quantitative di
marcatori di infezioni
● Controllo e validazione di kit per determinazione qualitativa e quantitativa di acidi nucleici
(NAT) quali marcatori di infezioni
● Controlli di kit diagnostici post-marketing su segnalazione
● Allestimento di pannelli sierici e Preparazioni Standard per controlli interni di qualità
● Attuazione di programmi nazionali di valutazione esterna di qualità (VEQ) per laboratori del
SSN
● Partecipazione a commissioni EU ed a Comitati Tecnici associati alla Direttiva 98/79/CE
● Organizzazione di convegni sulle specifiche tematiche rivolti a personale tecnico del SSN
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Gruppo di lavoro CdG/DMDV - Direttiva 98/79/CE (7 dicembre 1998)
SISTEMA DI GESTIONE DELL’AUTORIZZAZIONE (SGA)
Il sistema è articolato in modo da definire, per le varie fasi delle attività:
a) Politica e conduzione della certificazione;
b) Organizzazione tecnica, amministrativa e delle risorse umane;
c) Pianificazione delle attività interessate, ivi comprese l’assegnazione delle risorse e la documentazione;
d) Misura delle prestazioni conseguite con l’adozione del sistema, ivi incluse le verifiche ispettive (audit);
e) Verifica e riesame del sistema.
La struttura generale dell’ SGA risponde allo stato dell’arte in materia ed è schematizzabile nel seguente
modello logico:
Politica per la
Certificazione di dispositivi
medico-diagnostici in vitro
Verifica delle
soluzioni adottate
Controlli e azioni
correttive
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Pianificazione
delle attività
Miglioramento
continuo
Attuazione
dell’ SGA
Gruppo di lavoro CdG/DMDV - Direttiva 98/79/CE (7 dicembre 1998)
ARTICOLAZIONE DEL SISTEMA DI GESTIONE DELL’AUTORIZZAZIONE
L’ SGA è articolato nelle seguenti Sezioni e Sottosezioni:
Rif.
SEZIONI
1.
Politica dell’Istituto
2.
Controllo
dell’organizzazione
3.
4.
5.
Controllo delle
valutazioni di
conformità
Controllo delle
prestazioni
Revisione del sistema
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Cod.
SOTTOSEZIONI
1.1
Politica per la certificazione
1.2
Piano di attuazione della politica
2.1
Organizzazione
2.2
Personale
3.1
Richiesta di valutazione
3.2
Preparazione della valutazione
3.3
Conduzione della valutazione
3.4
Rapporto sulla valutazione
3.5
Modifiche ai requisiti della valutazione
3.6
Sorveglianza e rinnovo della
certificazione
4.1
Analisi e valutazione delle non
conformità
4.2
Verifiche ispettive interne
4.3
Reclami
5.1
Misura delle prestazioni del sistema
5.2
Riesame del sistema
ORGANIGRAMMA NOMINATIVO DEI RESPONSABILI DEL COMITATO DI
GESTIONE DEI DMDV
(CdG/DMDV - Dipartimento Malattie Infettive, Parassitarie ed Immunomediate - MIPI)
Direttiva 98/79/CE (7 dicembre 1998)
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
PROCEDURES FOR DIAGNOSTIC KITS CONTROL IN ITALY
(Decrees: 3 March 1987 (anti-HIV), 12 December 1991 (HBsAg, Anti-HCV)
• Licensing after the evaluations of technical documentation and of
sample kit by the Istituto Superiore di Sanità and by the Ministry of
Health*
• Batch release procedure by the Istituto Superiore di Sanità
• External quality control (NEQAS) by the Istituto Superiore di Sanità
* Any variation of components, expire date and production procedure must be authorised
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
REQUIREMENTS FOR TECHNICAL DOCUMENTATION
THE TECHNICAL DOCUMENTATION PROVIDED BY THE MANUFACTURERS MUST BE BASED,
FOR LICENSING PROCEDURE ON:
•
•
•
•
•
•
•
biological principles of methodology
production methods & characterization of each reagent
type of reagents and their shelf life including their assessment
description of testing procedures
adapted procedures for result assessment
sensitivity, specificity and accuracy (with description of the assessment methods)
information sheet, also in Italian, as an integral part of the kit, reporting the elements listed
above, handling precautions and limitation on the physical, biological and clinical aspects,
and the list of necessary but not provided materials
FOR BATCH RELEASE PROCEDURE, ON:
• series number of the batch and of the individuals components
• expire date of the batch and the individual reagents (which must comply with the registration
documentation)
• the number of kits in the batch
• quality control certificate and quality control assays performed by the manufacturer
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ANTI-HIV TESTING KITS (VEQ 2004)
Tradename Brand
Screening tests
Method
Manufacturer
AXSYM HIV 1/2 gO EIA
VIDAS HIV DUO
HIV COMBI EIA COBAS CORE
VITROS ANTI HIV 1+2
ENZYGNOST ANTI HIV 1/2 PLUS
ORTHO HIV-1/HIV-2 Ab CAPTURE ELISA TEST
BIOTEST ANTI-HIV TETRA ELISA
GENSCREEN HIV 1/2 versione 2
VIRONOSTIKA HIV UNI-FORM II PLUS O
ImX HIV-1/HIV-2 III PLUS
ACCESS HIV-1/2 NEW
ENZYGNOST HIV Integral
MUREX HIV- 1.2.O
COBAS CORE ANTI HIV 1-2-O EIA
ABBOTT HIV 1/2 gO EIA
MEIA 3 Gen
ELFA (FluorescenzaI Indirect sandwich 4 Gen
ECLIA (ElettroChemiLunescenza) sandwich 4 Gen
Immunometric luminescence 3 Gen
ELISA 3 Gen
ELISA 3 Gen
ELISA (sandwich) 3 Gen
ELISA (sandwich) 3 Gen
ELISA 3 Gen
MEIA 3 Gen
ChLIA (Immunometrico Chemioluminescenza)
ELISA (sandwich) 4 Gen
ELISA 3 Gen
ELISA 3 Gen
ELISA 3 Gen
ABBOTT
BIOMERIEUX
ROCHE
ORTHO
DADE BEHRING
ORTHO
BIOTEST
BIO-RAD
ORGANON
ABBOTT
BIO-RAD
DADE BEHRING
ABBOTT
ROCHE
ABBOTT
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ANTI-HCV and HBsAg TESTING KITS (VEQ 2004)
Tradename Brand
Screening tests
Method
Manufacturer
AXSYM HCV
COBAS CORE ANTI-HCV EIAS
ORTHO HCV 3.0 ELISA Test System with Enhanced SAVe
VITROS HCV
ARCHITECT ANTI HCV
IMX HCV v.3.0
INNO-TEST HCV Ab IV
ABBOTT HCV EIA 3.0
MONOLISA ANTI-HCV PLUS
ACCESS HCV PLUS
MEIA
ELISA (indirectI
ELISA
Immunometric luminescence
CMIA
MEIA
ELISA
ELISA
ELISA (indirect)
Enzyme Immunoassay (chemiluminescence)
ABBOTT
ROCHE
ORTHO
ORTHO
ABBOTT
ABBOTT
INNOGENETICS
ABBOTT
BIO-RAD
BIO-RAD
AXSYM HBsAg V. 2
COBAS CORE HBsAg EIA II
VIDAS HBsAg
VITROS HBsAg
ARCHITECT HBsAg
ELECSYS HBsAg
ETI MAK 4
ORTHO ANTIBODY TO HBsAg ELUSA TEST SYSTEM 3
ENZYGNOST HBsAg 5.0
IMX HBsAg
HEPANOSTIKA HBsAg UNIFORM II
SUPERMIK HBsAg
MONOLISA Ag HBs PLUS
ACCESS HBsAg
MEIA 3 Gen
ELISA sandwich
ELFA (Enzyme Linked Fluorescent assay)
Immunometric luminescence
CMIA (chemiluminescent microparticle immunoassay)
ECLIA (ElettroChemiLuminescenza)
ELISA direct sandwich
ELISA 3 Gen
ELISA
MEIA
ABBOTT
ROCHE
BIOMERIEUX
ORTHO
ABBOTT
ROCHE
DIASORIN
ORTHO
DADE BEHRING
ABBOTT
ORGANON
MED. SYSTEM
BIO-RAD
BIO-RAD
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ELISA sandwich
ELISA sandwich
HIV, HBV, HCV NAT TESTS
Tradename Brand
Screening tests
COBAS AMPLISCREEN HCV TEST v. 2.0
COBAS AMPLISCREEN HIV-1 TEST v. 1.5
COBAS AMPLISCREEN HBV TEST
PROCLEIX HIV-1/HCV
PROCLEIX ULTRIO ASSAY
Manufacturer
ROCHE
ROCHE
ROCHE
CHIRON
CHIRON
HIV, HBV, HCV CONFIRMATORY TESTS
CHIRON RIBA HCV 3.0 SIA
INNO-LIA HCV Ab III UPDATE
DECISCAN HCV PLUS
HIV BLOT 2.2
NEW LAV BLOT I Ac Ab Ak
CHIRON RIBA HIV-1/HIV-2 SIA
INNO-LIA HIV K1036 IT
INNOLIA HIV CONFIRMATION
BIOBLOT HIV-1 PLUS
ELECSYS HBsAG CONFIRMATORY
COBAS CORE HBsAg II CONFIRMATORY EIA
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
CHIRON
INNOGENETICS
SANOFI-PASTEUR
ALFA BIOTECH
BIO-RAD
ORTHO
ONNOGENETICS
INNOGENETICS
INSTRUMENTATION LAB.
ROCHE
ROCHE
DISTRIBUZIONE CENTRI PARTECIPANTI NEL 1994 E NEL 2003
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
TIPOLOGIA DEI CAMPIONI POSITIVI INVIATI
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
DISTRIBUZIONE GEOGRAFICA E
PERCENTUALE DI
COPERTURA DEI CENTRI PARTECIPANTI
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
CHARACTERISTICS OF POSITIVE SAMPLES OF
EACH SHIPMENT PANEL, BY YEAR
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
EU IVD DIRECTIVE
Directive 98/79/EC of the European Parliament and of the Council on in
vitro Diagnostic Medical Devices
- adopted on 5 October 1998
- published in Official Journal of EU Committees on 7 December 1998
- published in Italian GU n. 269 on 17 November 2000
■ has introduced at EU level common regulatory requirements for safety quality and
performance of IVDs
■ applies to:
reagents and reagent products, calibrator materials or instruments including specimen
receptacles intended by the manufacturer for the in vitro examination of human tissue,
blood or fluid samples for the purpose of providing information about a patient’s state of
health
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
ANNEX I
ESSENTIAL REQUIREMENTS
The manufacturer has to demonstrate that the in vitro diagnostic medical devices:
■ do not compromise the health and safety of patients and users
■ are designed and manufactured to be suitable for the stated medical purpose, taking into account of
the generally acknowledged state of the art
■ are able to achieve the performance, where appropriate, in terms of: analytical sensitivity, diagnostic
sensitivity, analytical specificity, diagnostic specificity, accuracy, repeatability, reproducibility, including
control of known relevant interferences, and limits of detection.
■ possess the elements of traceability, i.e.:
a - The values assigned to calibrators and/or control materials, are assured through available
reference measurement procedures and/or available reference materials of a higher order.
b - are designed, manufactured and packed in such a way that their characteristics and
performances during their intended use will not be adversely affected under storage and transport
conditions
c - labeling information and instructions for use, both for devices intended for professional use
and for self-tests are addressed to lay persons.
■ Is characterized by risk analysis including the identification and demonstration of acceptability of
risks related with their use.
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
CLASSIFICATION OF IVDS INTO CATEGORIES
1 - Devices listed in Annex II-List A
Reagents and reagent products for detection of infections by HIV 1 and 2, HTLV-I and II or by
hepatitis B, C and D viruses. Reagents for determination of ABO system, Rhesus-C, c, D, E, e,
anti-Kell.
2 - Devices listed in Annex II-List B
Reagents and reagent products for determination of anti-Duffy, anti-Kidd, irregular antierythrocytic antibodies, tumor marker PSA, HLA tissue groups DR, A, B, detection of
phenylketonuria, detection of the infectious diseases: rubella, toxoplasmosis, cytomegalovirus
and chlamydia, detection of trisomy 21. Self-testing devices for the measurement of blood
glucose.
3 - Devices for self-testing
4 - All other devices not listed in Annex II and not intended for self-testing
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Document GHTF/SG1/N045: 2008
PROPOSED GENERAL CLASSIFICATION SYSTEM
FOR IVD MEDICAL DEVICES
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR IN VITRO DIAGNOSTIC
MEDICAL DEVICES LISTED IN ANNEX II-LIST-A
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR IN VITRO DIAGNOSTIC
MEDICAL DEVICES LISTED IN ANNEX II-LIST-B
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTES FOR IN VITRO DIAGNOSTIC
MEDICAL DEVICES TO BE USED FOR SELF-TESTING
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
CONFORMITY ASSESSMENT ROUTE FOR GENERAL IN VITRO
DIAGNOSTIC MEDICAL DEVICES
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Document GHTF/SG1/N045: 2008
CONCEPTUAL ILLUSTRATION OF REGULATORY REQUIREMENTS
INCREASING WITH DEVICE RISK CLASS
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
SCREENING ASSAYS: ANTI-HIV 1 AND 2, ANTI-HTLV I AND II,
ANTI-HCV, HBSAG, ANTI-HBC
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
NAT ASSAYS FOR HIV 1, HCV, HBV, HTLV I/II
(QUALITATIVE AND QUANTITATIVE; NOT MOLECULAR TYPING)
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
1
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
2
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
3
For quantitative NATs a study shall be performed on at least 100 positive specimens reflecting the routine
conditions of users (e.g. no pre-selection of specimens). Comparative results with another NAT test system
shall be generated in parallel.
For qualitative NATs a study on diagnostic sensitivity shall be performed using at least 10 seroconversion
panels. Comparative results with another NAT test system shall be generated in parallel.
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
RAPID TESTS: ANTI- HIV 1 AND 2, ANTI-HCV, HBSAG,
ANTI-HBC, ANTI-HTLV I AND II
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
COMMON TECHNICAL SPECIFICATIONS (CTS) 2009/108/EC amending 2002/364/EC
HIV 1 ANTIGEN
SEROTYPING AND GENOTYPING ASSAY: HCV
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
DEFINITION OF THE “STATE OF ART” FOR HIV DETECTION DEVICES
INCLUDING HIV AG/AB COMBINATION ASSAYS,
ANTI-HIV-1/2 ASSAYS AND HIV RAPID TESTS
Common Technical Specifications (CTS, 3 February 2009 amending Decision 2002/364/EC)
“diagnostic tests sensitivity during the early infection phase (sero-conversion) has to
represent the state of art”. Furthermore, two categories of samples are defined:
Early sero-conversion HIV samples:
- p24 antigen and/or HIV RNA positive and;
- not recognised by all of the antibody screening tests and;
- indeterminate or negative confirmatory assays
Sero-conversion HIV:
- p24 antigen and/or HIV RNA positive and;
- recognised by all of the antibody screening tests and;
- positive or indeterminate confirmatory assays
HIV tests shall identify all sero-conversion HIV samples as positive; and at least 40 early
sero-conversion HIV samples shall be tested. Results should conform to the state of the
art.
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
SERO-CONVERSION PANELS USED
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY IN RECOGNITION OF HIV INFECTION
RELATIVE TO NAT (DAYS)
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY OF HCV INFECTION (DAYS)
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
DETECTION DELAY OF HBSAG INFECTION (DAYS)
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
SUMMARY RESULTS OF THE SERO-CONVERSION STUDY
HIV 1/2, Ab TEST KIT
Test kit
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
Directive 98/79/CE (7 December 1998)
ANNEX III sect. 3
TECHNICAL DOCUMENTATION
Must include:
1 - General description of the product
2 - Documentation of the quality system
3 - Design information including origin of material; drawings and diagrams and the
operation of the product; description of the procedures used for sterile products; labels
and instructions for use
4 - Results of the risk analysis
5 - Results of the design calculations and of the inspections carried out
6 - The test reports
7 - The results of stability studies
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases
SUMMARY RESULTS OF THE SERO-CONVERSION STUDY
HIV 1/2 Ag/Ab TEST KIT
Test kit
ISTITUTO SUPERIORE DI SANITA’
Department of Infectious,
Parasitic and Immunomediated Diseases