Selection of certification route
(conformity assessment procedure)
Annexes II - VII of
the Medical Devices Directive 93/42/EEC (MDD)
Annex II
– EC Declaration of Conformity (Full Quality Assurance System):
Most comprehensive conformity assessment procedure referring to a full quality system
including the design phase for new devices or changes of existing devices; Section 4
(Examination of the Design of the Product) applies only to class III devices; this Section
is similar to Annex III - EC Type-Examination with the difference that in-house test
results obtained by the manufacturer under his full quality management system may be used
as the basis of certification; the manufacturer may choose the harmonized standards EN ISO
13485 in combination with the respective guidance standard as
the basis of his quality system or use an equivalent quality system suitable to fulfill
the requirements of the MDD.
Annex III - EC Type
Examination:
A conformity assessment procedure for the product design which involves examination and
third party testing of representative samples of the device and certification that the
device meets the applicable essential requirements of the MDD; EC Type Examination is
applicable only to class IIb and III devices.
Annex IV - 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 class IIa, IIb and III devices.
Annex V - EC
Declaration of Conformity (Production Quality Assurance):
A conformity assessment procedure for the quality system of the manufacturer excluding the
design phase of new devices but including all other aspects of conformity with the MDD;
this conformity assessment procedure is the most suitable procedure for sterile class IIa
devices, if the manufacturer does not choose the Annex II as the basis of certification;
it may also be applied to class IIb and III devices in combination with Annex III; the
manufacturer may base his quality system on the harmonized standards EN ISO 13485.
Annex VI - EC
Declaration of Conformity (Product Quality Assurance):
A conformity assessment procedure for the quality system for manufacturers of devices
whose relevant properties can be assessed in final inspection; the manufacturer may base
his quality system on the standard EN ISO 13485; this conformity assessment procedure is not
suitable for devices involving special manufacturing processes requiring validation, like
sterilization; Annex VI may not be used for the assessment of class III products.
Annex VII - EC Declaration of
Conformity:
A conformity assessment procedure in which the manufacturer himself declares the
compliance of his devices with the MDD; suitable for class I devices, and required for
class IIa devices in combination with one of the Annexes IV, V, or VI.
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