Biomedical Engineering Reference
In-Depth Information
These alternative procedures are mandatory for sterilised devices.
• As an alternative the manufacturer must receive approval of the “total quality
assurance system” by a notifi ed body, with the exception of having to apply the
product design examination.
For “Class II b” Devices
At the manufacturer or agent
'
s choice, these products must obtain:
•
The “EC type examination” and depending on the choice:
-
The “EC verifi cation” by a notifi ed body
-
Approval of the “production quality system” by a notifi ed body
-
Approval of the “product quality system” by a notifi ed body
• As an alternative the manufacturer must receive approval of the “total quality
assurance system” by a notifi ed body, with the exception of having to apply the
product design examination.
For “Class III” Devices
At the manufacturer or agent
'
s choice, these products must obtain:
• The “EC type examination” and depending on the choice:
-
The “EC verifi cation” by a notifi ed body
-
Approval of the “production quality system” by a notifi ed body
-
Approval of the “product quality system” by a notifi ed body
• As an alternative the manufacturer must receive approval by the “total quality
assurance system” by a notifi ed body, including having to apply the product
design examination.
For devices intended for clinical research and custom-made devices, the manu-
facturer must prepare a declaration in accordance with the criteria in Annex VIII of
the directive. These research-oriented devices should not to bear the CE conformity
mark.
The directive does not identify any quality system standard, but the requirements
provided to create the quality system are subject to ISO 9000 Series regarding the
total quality system, the production quality system and the end product quality sys-
tem. In order to evaluate the technical competence of the notifi ed bodies, the mem-
ber countries of the EU must implement the criteria laid down in Annex XI of the
directive.
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