European Commission - Growth

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Notification

Found : 4
 
  Body :

BSI Assurance UK Ltd
Kitemark Court Davy Avenue Knowlhill
Milton Keynes MK5 8PP
Country : United Kingdom

Phone : +44 (0) 8450 809000
Fax : +44 (0) 8450 809000

Email : product.certification@bsigroup.com
Website : www.bsigroup.com

Notified Body number : 0086

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices    
Last approval date : 28/01/2020                 Version(s): 1 2 3 4 5 6 7

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
Annex 2
Annex 5
Annex 3
 
   - *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)
Annex 2
Annex 5
 
   - *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)
Annex 2
Annex 5
 
 
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 7003 - Medical devices incorporating derivates of human blood according to Directive 2000/70/EC, amended by Directive 2001/104/EC  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), others (need to be specified)
*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  
*MDS 7010 - Medical devices incorporating software / utilising software / controlled by software