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[유럽] MEDDEV 2.1 의료기기 적용범위, 적용분야, 정의에 대한 가이던스

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MEDDEV 2.1/1 Definitions of 'medical devices', 'accessory' and 'manufacturer'

April 1994

MEDDEV 2.1/2 rev.2 Field of application of directive 'active implantable medical devices'

April 1994

MEDDEV 2.1/2.1 Treatment of computers used to program implantable pulse generators

February 1998

MEDDEV 2.1/3 rev.3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative

December 2009

MEDDEV 2.1/4 Interface with other directives – Medical devices Directive 89/336/EEC relating to electromagnetic compatibility and Directive 89/686/EEC relating to personal protective equipment

March 1994

For the relation between the MDD and Directive 89/686/EEC concerning personal protective equipment, please see the Commission services interpretative document of 21 August 2009

MEDDEV 2.1/5 Medical devices with a measuring function

June 1998

MEDDEV 2.1/6 Qualification and classification of stand alone software

July 2016

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MEDDEV 2.1_6 Qualification and classification of stand alone software.pdf

MEDDEV 2.1_5 Medical devices with a measuring function.pdf

MEDDEV 2.1_4 Interface with other directives – Medical devices Directive 89336EEC relating to electromagnetic compatibility and Directive 89686EEC relating to personal protective equipment.pdf

MEDDEV 2.1_3 Borderline products, drug-delivery products and medical devices incorporating,as integral part, an ancillary medicinal substance or an ancillary human blood derivative.pdf

MEDDEV 2.1_2.1 Treatment of computers used to program implantable pulse generators.pdf

MEDDEV 2.1_2 Field of application of directive 'active implantable medical devices'.pdf

MEDDEV 2.1_1 Definitions of 'medical devices', 'accessory' and 'manufacturer'.pdf