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Notification

Found : 27
 
  Body :

ISTITUTO SUPERIORE DI SANITA'
Viale Regina Elena, 299
00161 - ROMA
Country : Italy

Phone : +39 06 49906146
Fax : +39 06 49903150

Email : roberta.marcoaldi@iss.it
Website : www.iss.it

Notified Body number : 0373

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 24/07/2017                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0105 - Non-active ophthalmologic devices
EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex II
Annex V
Annex VI
Annex III limited to ophthalmic solutions 
   - *MD 0106 - Non-active instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0107 - Contraceptive medical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0110 - Non-active medical devices for ingestion
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 0200 - Non-active implants
 
   - *MD 0201 - Non-active cardiovascular implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0202 - Non-active orthopaedic implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0203 - Non-active functional implants
EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex II
Annex V
Annex III limited to injectable visco-elastic solutions for intra-articular use 
   - *MD 0204 - Non-active soft tissue implants
EC type-examination
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex III
Annex II
Annex V
Annex III limited intradermal fillers 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0302 - Suture material and clamps
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0303 - Other medical devices for wound care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0402 - Dental materials
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0403 - Dental implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 1100 - General active medical devices
 
   - *MD 1104 - Active surgical devices
EC declaration of conformity (full quality assurance system) Annex II  
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
EC type-examination
EC verification
Annex III
Annex IV
Limited to accelerator for hadron therapy and related dose delivery system 
 
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 7006 - Medical devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam, moist heat sterilisation, radiation sterelisation (gamma, electron beam)
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed  
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software