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Notification

Found : 4
  Body :

AGENCIA ESPAƑOLA DE MEDICAMENTOS Y PRODUCTOS SANITARIOS
Campezo 1. Edificio 8
28022 MADRID
Country : Spain

Phone : +34:91:822 52 52
Fax : +34:91:822 52 89

Email : on0318@aemps.es
Website : -

Notified Body number : 0318

Version(s): 1 2

Last update : 21/10/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices    
Last update : 28/06/2013                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
*AIMD 0100 - General active implantable medical devices
 
   - *AIMD 0101 - Active implantable medical devices for stimulation / inhibition
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
 
   - *AIMD 0102 - Active implantable medical devices delivering drugs or other substances
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
 
   - *AIMD 0103 - Active implantable medical devices substituting or replacing organ functions
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
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances according to Directive 2001/83/EC  
*MDS 7002 - Medical devices utilising tissues of animal origin including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013)  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7005 - Medical devices referencing the Directive 89/686/EEC on PPE (personal protective equipment)  
*MDS 7006 - Medical devices in sterile condition  
*MDS 7007 - Medical devices utilising micromechanics  
*MDS 7008 - Medical devices utilising nanomaterials  
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbd  
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