CE-marking of In Vitro Diagnostic
Medical Devices
- An Overview
-
A new legal requirement:
Since December 1998 the European Directive 98/79/EC on in vitro diagnostic medical devices
is published and asks all member states to transpose the requirements of this directive
into their national law. In the future all in vitro diagnostic medical devices will have
bear the CE mark to be placed on the market in the member states of the European Union.
In vitro diagnostic
medical devices:
Under the Directive
98/79/EC (IVDD), an in vitro diagnostic device means any medical device which is a
reagent, reagent product, calibrator, control material, kit, instrument, apparatus,
equipment, or system, whether used alone or in combination, intended by the manufacturer
to be used in vitro for the examination of specimens, including blood and tissue
donations, derived from the human body, solely or principally for the purpose of providing
information:
concerning a physiological
or pathological state, or
concerning a congenital
abnormality, or
to determine the safety and
compatibility with potential recipients, or
to monitor therapeutic
measures.
Specimen receptacles are
'in vitro diagnostic medical devices'. A 'specimen receptacle' is a device, whether
vacuum-type or not, which is specifically intended by the manufacturers for the primary
containment and preservation of specimens derived from the human body for the purpose of
in vitro diagnostic examination. Accessories, that means articles, which are not IVDs, but
which are intended to be used with IVDs are also covered by the Directive. Products for
general laboratory use are not in vitro diagnostic medical devices unless such products
are specifically intended by their manufacturer to be used for in vitro diagnostic
examination.
Categorization of in
vitro diagnostic medical devices:
The following groups are
subject to different regulatory requirements to be CE -marked:
1. Products according to Annex
II, List A:
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
- 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.
2. Products according to Annex
II, List B:
Reagents and reagent products,
including related calibrators and control materials, for:
- determining the blood groups
anti-Duffy and anti-Kidd,
- determining irregular
anti-erythrocytic antibodies,
- detection and quantification
of the infections rubella and toxoplasmosis,
- determining the infections
cytomegalovirus and chlamydia,
- diagnosing phenylketonuria,
- determining the HLA tissue
groups: DR, A, B,
- determining the tumor marker
PSA,
Reagents and reagent products,
including related calibrators, control materials and software for evaluating the risk of
trisomy 21,
Devices for self-diagnosis
including related calibrators, control materials measurement of blood sugar.
3. Products for self-testing:
Devices intended to be used by
a lay user in a home environment.
4. All other products:
Devices, not Listed in Annex
II and not intended for self-testing.
Some requirements:
Regardless of the
aforementioned groups all IVDs must meet the essential requirements for safety,
performance and labeling as specified in Annex I of the IVDD. All IVDs must be
manufactured under a quality system and for all IVDs technical documentation according to
Annex III must be available.
Similar to other European
medical device directives, there are several conformity assessments routes. The
involvement of a notified body is required for Annex II devices and IVDs for self-testing.
For all other devices self-declaration is sufficient to affirm conformity.
Transitional
provisions:
CE-marking and
certification according to the IVDD is possible since June 7, 2000. From December 7, 2003,
the IVDD becomes mandatory for all IVDs to be placed on the market. Until December 7, 2005
IVDs without the CE -mark, which are already placed on the market, may be put into
service.
|
