Annexes III - VII of the In Vitro
Diagnostic Directive 98/79/EC (IVDD)
ANNEX III - EC
DECLARATION OF CONFORMITY:
A conformity assessment
procedure in which the manufacturer himself declares the compliance of his devices with
the IVDD. This is required for all in vitro diagnostic devices, except those listed in
Annex II or devices for performance evaluation. For devices for self-testing the
manufacturer has to lodge in addition an application for examination of the design,
according to section 6, with a Notified body.
The examination of the
design is a complete assessment of the technical file for compliance with the essential
requirements according to Annex I.
ANNEX IV - FULL
QUALITY ASSURANCE SYSTEM:
Most comprehensive
conformity assessment procedure for the aspect of quality systems. A full quality
assurance system has to include all steps from the product development right through to
the end control. The manufacturer may choose the harmonized standards EN
ISO 13485 as the basis
of his quality system or use an equivalent quality system suitable to fulfill the
requirements of the IVDD. This procedure is applicable for all products according to Annex
II and may be implemented for devices for self-testing. Section 4 describes the
examination of the design of the product, which applies to Annex II List A devices. This
Section is similar to Annex V - EC Type-Examination with the difference, that in-house
test results obtained by the manufacturer under his full quality management system can be
acknowledged by the Notified body. For the devices according to Annex II List A
verification of the manufactured products (batch release) by a Notified body, according to
section 6, is necessary.
ANNEX V - EC
TYPE-EXAMINATION:
A conformity assessment
procedure for the product design which involves examination and testing of representative
samples of the device by a Notified Body and certification that the device meets the
applicable essential requirements. Manufacturer supplied test reports should originate
from a third party and fulfill certain criteria. Testing by the manufacturer is possible
under supervision of the Notified body. EC type-examination may be applicable to List A
devices and devices for self-testing. In each case Annex V is only allowable in
combination with either Annex VI or Annex VII.
ANNEX VI - EC
VERIFICATION:
A conformity assessment
procedure in which the Notified Body examines and tests every individual device or devices
taken on a statistical basis, if the manufacturer manufactures homogeneous batches. The
Notified Body releases individual devices or batches. EC Verification may be applied to
Annex II List B devices and for devices for self-testing in combination with an EC type
examination.
This conformity assessment
process refers to a quality system has to include all steps (with the exception of the
design phase) from the raw material supply right through to the end control. Application
of the quality system must ensure that the devices conform to the type described in the EC
type-examination certificate. The manufacturer may choose the harmonized standard
standards EN ISO 13485 as the basis of his quality system. Annex VII, in combination
with Annex V, may be followed for all Annex II IVDs and devices for self-testing. For
Annex II List A products verification of the manufactured products (batch release) by a
Notified body, according to section 5, is necessary.
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