IVDD: The In vitro Diagnostic
Directive 98/79/EC - Introduction
There are three directives for medical
devices:
The following material refers
to the IVDD, although most provisions are much the same under the other two medical device
directives.
Under the IVDD an 'in vitro
diagnostic medical 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, in cluding 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
considered to be in vitro diagnostic medical devices. 'Specimen receptacles' are those
devices, whether vacuum-type or not, specifically intended by their manufacturers for the
primary containment and preservation of specimens derived from the human body for the
purpose of in vitro diagnostic examination.
'Products for general
laboratory use' are not in vitro diagnostic medical devices unless such pro ducts, in view
of their characteristics, are specifically intended by their manufacturer to be used for
in vitro diagnostic examination.
An 'accessory' means an
article which, whilst not being an in vitro diagnostic medical device, is intended
specifically by its manufacturer to be used together with a device to enable that device
to be used in accordance with its intended purpose. For the purposes of this definition,
invasive sampling devices or those, which are directly applied to the human body for the
purpose of obtaining a specimen' within the meaning of Directive 93/42/EEC shall not be
considered to be accessories to in vitro diagnostic medical devices.
'Manufacturer' means the
natural or legal person with responsibility for the design, manufacture, packaging and
labelling of a device before it is placed on the market under his own name, regardless of
whether these operations are carried out by that pers on himself or on his behalf by a
third party. The obligations of this Directive to be met by manufacturers also apply to
the natural or legal person who assembles, packages, processes, fully refurbishes and/or
labels one or more ready-made products and/or assigns to them their intended purpose as
devices with a view to their being placed on the market under his own name.
All in vitro diagnostic
devices must meet the applicable 'essential requirements' on safety, performance and
labeling as outlined in Annex I of the IVDD. Safety requirements are not restricted to
patients but include users and, where applicable, other persons. The fulfillment of the
essential requirements has to be demonstrated by the manufacturer for all devices whether
they are new devices or whether they have already been on the market in former times.
Under the IVDD there are no provisions for a 'grandfathering' approach.
'Labeling' may be and in
general is required by each Member State in its national language(s); the use of symbols
is recommended.
For in vitro diagnostics there
is no 'classification' as according to the directive 93/42/EEC. However, there is a
categorization is as follows:
Devices according to Annex
II, List A
Devices according to Annex
II, List B
Devices for self testing
Devices for performance
evaluation
All other in-vitro
diagnostics
Depending on the category
the manufacturer has to carry out a suitable conformity assessment, as stipulated in
Article 9 of the IVDD, according to the relevant Annexes III, IV, V, VI or VII.
Regardless of the category
a device belongs to, the manufacturer is obliged to maintain a ' technical file' for the
respective device or device family. Moreover, it is his responsibility to issue and keep
on file 'declarations of conformity' for his devices.
In principle for all
devices there must be a performance evaluation. The manufacturer must present valid data
demonstrating performance based on a reference system (as far as is possibly available).
The submitted data shall provide information as to refer ence processes, reference
materials, known reference values, specificity and measurement units. This data shall
originate from experiments in a clinical or suitable equivalent environment or
alternatively from relevant literature.
Particulars concerning the
performance evalaution can be found in the European standard EN 13612 (presently a draft)
and the Common Technical Specifications (CTS).
IVDD, Article 10 rules
that, manufacturers who place devices on the market shall notify the competent
authorizies. Where a manufacturer without a registered place o f business in a Member
State of the EU places devices on the EU market, he shall designate a 'responsible person'
who is established in the Community (e.g. authorized representative).
As from the 8th of December
2004 no in-vitro diagnostic devices, covered by the IVDD, shall be placed on the market
that do not bear a CE mark. 'Placing on the market' means the first making available in
return for payment or free of charge of a device other than a device intended for
performance evaluation with a view to dis tribution and/or use on the Community market,
regardless of whether it is new or fully refurbished.
For 'putting into service'
devices without CE mark there is an extended 'transition period', which will end at 07
December 2006. 'Putting into service' means the stage at which a device has been made
available to the final user as being ready for use on the Community market for the first
time for its intended purpose.
The only devices not
requiring a CE mark are 'devices for performance evaluation' where the manufacturer must
keep documentation in accordance with MDD Annex VIII.The IVDD does not apply to devices
manufactured and used only within the same health institution and on the premises of their
manufacture or used on premises in the immediate vicinity without having been transferred
to another legal entity.
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