Products |
Procedures |
Articles/Annexes |
Limitations |
*AIMD 0100 - General active implantable medical devices
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- *AIMD 0101 - Active implantable medical devices for stimulation / inhibition
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EC declaration of conformity (complete quality assurance system) EC declaration of conformity to type (assurance of production quality) EC type-examination EC verification |
Annex 2 Annex 5 Annex 3 Annex 4 |
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- *AIMD 0102 - Active implantable medical devices delivering drugs or other substances
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EC declaration of conformity (complete quality assurance system) EC declaration of conformity to type (assurance of production quality) EC type-examination EC verification |
Annex 2 Annex 5 Annex 3 Annex 4 |
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- *AIMD 0103 - Active implantable medical devices substituting or replacing organ functions
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EC declaration of conformity (complete quality assurance system) EC declaration of conformity to type (assurance of production quality) EC type-examination EC verification |
Annex 2 Annex 5 Annex 3 Annex 4 |
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Horizontal technical competence |
Limitations |
*MDS 7001 - Medical devices incorporating medicinal substances according to Directive 2001/83/EC |
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*MDS 7002 - Medical devices utilising tissues of animal origin including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013) |
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*MDS 7003 - Medical devices incorporating derivates of human blood according to Directive 2000/70/EC, amended by Directive 2001/104/EC |
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*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery |
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*MDS 7006 - Medical devices in sterile condition |
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*MDS 7007 - Medical devices utilising micromechanics |
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*MDS 7008 - Medical devices utilising nanomaterials |
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*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbd |
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*MDS 7010 - Medical devices incorporating software / utilising software / controlled by software |
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