93/42/EC and
98/79/EC directives
European Directives are the basis of applicable
regulation.
These Directives specify the essential requirements
in term of safety and effectiveness and define modality of evaluation of the
conformity.
Conformity to these Directives results in EC mark
93/42/EC relative to medical devices (excluding
active implantable medical devices) (applicable since June 14, 1998)
98/79/EC relative to diagnostic in vitro in vitro
(applicable on December 7, 2003)
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Medical devices
(Dir 93/42) EC Mark
Medical devices (93/42 Directive) are classified under 4 classes
with specific modalities to evaluate the conformity.
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Class I
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Low potential Risk (reusable surgical instruments,
non invasive medical devices)
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Class IIa
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Moderate potential Risk (Contact lenses, Single
use surgical instrument, short term invasive medical devices)
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Class IIb
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High potential Risk (Long term invasive /
implantable medical devices)
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Class III
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Critical potential Risk (long term implantable
medical devices in contact with central circulatory system and nervous
system, resorbable medical devices, mammary implant, joint implants)
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Because of numerous exceptions, one must systematically refer to rules
of classification detailed in annex IX of the Directive.
Conformity assessment procedures
Depend on both class of medical devices and quality system
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Class I
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Annex VII : EC Declaration of Conformity (Technical file) Notified body not
required
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Class IIa
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Annex II point 3 Full Quality Assurance System Notified body certification or
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Annex VII + Annex IV (EC verification by notified Body) or
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Annex VII + Annex V (Production Quality Assurance Notified body certification) or
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Annex VII + Annex VI (Product Quality Assurance- Notified body certification)
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Class IIb
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Annex II point 3 Full Quality Assurance System Notified body certification or
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Annex III (EC type Examination by notified body) + Annex IV (EC
verification by notified Body) or
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Annex III (EC type Examination by notified body) + Annex V (Production
Quality Assurance Notified body certification) or
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Annex III (EC type Examination by notified body) + Annex VI (Product
Quality Assurance Notified body
certification)
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Class III
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Annex II point 4 Full Quality Assurance System Notified body certification) + Annex
IV EC verification by notified Body or
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Annex III (Full Quality Assurance System Notified body certification) + Annex
IV EC verification by notified Body) or
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Annex III (Full Quality Assurance System Notified body certification) + Annex
V (Production Quality Assurance Notified body certification)
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NF IN ISO 13485
NF IN ISO 13485 (February 2004) Medical devices - Quality management
systems - Requirements for regulatory purposes is founded on the requirements
of the systems of management of the quality of the regulations in force in
the whole world and on the requirements of the ISO 9001:2000, the ISO 13485
provides the requirements to be respected by a manufacturer of medical
devices to meet the world lawful requirements on the systems of management of
quality and to provide effective and protected devices. The provisions
relating to the satisfaction of the customers and the continuous improvement
of quality are excluded. The requirements specific to health are identified
by characters in italic
Diagnostic in
vitro devices (DIR 98/79) EC mark
In vitro diagnostic devices are classified under 5 classes with
specific modalities to evaluate the conformity.
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List A
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Reagents and reagent products, including related
calibrators and control materials, for determining the following blood groups:
ABO system, rhesus (C, c, D, E, e) anti-Kell, Reagents and reagent
products, including related calibrators and control materials, for the
detection, confirmation and quantification in human specimens of markers of
HIV infection (HIV 1 and 2), HTLV I and II, and hepatitis B, C and D
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List B
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Reagents and reagent products, including related
calibrators and control materials, for determining the following blood
groups: anti-Duffy and anti-Kidd, for determining irregular
anti-erythrocytic antibodies, for the detection and quantification in human
samples of the following congenital infections: rubella, toxoplasmosis, for
diagnosing the following hereditary disease: phenylketonuria, for
determining the following human infections: cytomegalovirus, chlamydia, for
determining the following HLA tissue groups: DR, A, B, for determining the
following tumoral marker: PSA, control materials and software, designed
specifically for evaluating the risk of trisomy 21, device for the
measurement of blood sugar
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Device for performance evaluation
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Auto-diagnostic devices
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Other in vitro diagnostic devices
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Conformity assessment procedures
Depend on both medical devices and quality system
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List A
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Annex IV (Full Quality Assurance System certification by a notified body) or
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Annex VII (Manufacturing Assurance System certified by a notified body) + Annex
V (EC examination by a notified body)
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List B
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Annex IV (Full Quality Assurance System certification by a notified body) or
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Annex V (EC type examination by notified body) + Annex VI (EC
verification by notified body)
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Annex V (EC type examination by notified body) + Annex VII
(Production Quality Assurance)
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Device for performance evaluation
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Annex VIII statement and procedures concerning devices for performance
evaluation
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Auto-diagnostic device
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Annex III EC Declaration of Conformity (Technical file) Notified body not
required + point 6 (examination of the design with a notified body)
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Other in vitro diagnostic devices
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Annex III EC Declaration of Conformity (Technical file) Notified body not
required
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