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EN46001:1997/ ISO13485:2000
What is EN46001?
EN46001 is the European standard for medical device industries. It
makes sure suppliers of medical products are in accordance with European
standard EN 46001. In accordance with EEC Directives fulfillment of
this standard is the prerequisite for medicine industry products.
It describes the special requirements, which go beyond the standard
ISO 9001 that have to be met by the quality management systems of
suppliers. The certification of a quality management system, specifically
for medical devices, to ISO 9001/ISO 13485/EN 46001 proves advantageous,
and in many cases essential, for medical companies which export their
products to the global market.
Prerequisite for CE Mark
The European EN 46001 standard has been developed as an add-on to
ISO 9001 to cover quality management and assurance in the field
of medical technology manufacturers and suppliers. EN 46001 has
become a prerequisite for certification of the European Directive
for Medical Devices (93/42/EEC) and thus for the CE Mark.
What is ISO13485 ?
The European harmonized medical device quality system standards
are EN ISO 13485:2000 and EN ISO 13488:2000. These two standards
will replace current harmonized standards EN 46001 and EN 46002
(transition period until March 2004), as published in the Official
Journal (OJ) of the European Community on July 31, 2002.
Who should be certified to EN46001/ ISO13485
standards?
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Companies who currently manufacture private
label medical devices, but want to eventually place these devices
under their name on the market in the European Union |
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Companies, such as consulting shops, which
design, manufacture, and assemble medical and in vitro diagnostic
medical devices, and medical component manufacturers |
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Manufacturers of In Vitro Diagnostic Medical
Devices that want to distinguish themselves, and prepare for
future IVD regulatory obligations to enter the EU |
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