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Notification

Found : 44
  Body :

Oficiul Tehnic de Dispozitive Medicale Certificare-OTDM CERTIFICARE
B-dul Nicolae Titulescu nr. 58, sector 1, cod postal 011144
Bucuresti
Country : Romania

Phone : +4031-432 91 20
Fax : +4031-432 91 21

Email : contact@otdm-certificare.ro
Website : www.otdm-certificare.ro

Notified Body number : 1868

Version(s): 1 2 3

Last update : 03/10/2013
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 03/10/2013                 Version(s): 1 2 3

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 declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *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 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 declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 0204 - Non-active soft tissue implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*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 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1103 - Devices for stimulation or inhibition
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1104 - Active surgical devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1105 - Active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1106 - Active dental devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1107 - Active devices for disinfection and sterilisation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1109 - Active devices for patient positioning and transport
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1403 - Devices for hyperthermia / hypothermia
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
Annex II
Annex V
 
 
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 personal protective equipment (PPE)  
*MDS 7006 - Medical devices in sterile condition  
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed  
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