European Commission - Growth

For a better experience, please enable Javascript!


Notification

Found : 41
 
  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

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 06/07/2018                 Version(s): 1 2 3 4

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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
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 limitated to punture, injection and/or extraction of fluids medical devices 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0104 - Non-active medical devices with measuring function
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0105 - Non-active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0106 - Non-active instruments
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0107 - Contraceptive medical 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 limitated to male latex condoms 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
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 limitated to contact lenses care products 
   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0110 - Non-active medical devices for ingestion
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to stents 
   - *MD 0202 - Non-active orthopaedic implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0203 - Non-active functional implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding neurological and neurosurgical implants 
   - *MD 0204 - Non-active soft tissue implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding breast implants 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0302 - Suture material and clamps
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0303 - Other medical devices for wound care
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0402 - Dental materials
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 0403 - Dental implants
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Excluding infusion pumps for the delivery of medicines 
   - *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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1103 - Devices for stimulation or inhibition
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1105 - Active ophthalmologic devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to diagnostic medical devices 
   - *MD 1106 - Active dental devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1107 - Active devices for disinfection and sterilisation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system) Annex II  
   - *MD 1112 - Medical gas supply systems and parts thereof
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to X-ray medical devices and gamma cameras 
*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)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1402 - Devices utilising non-ionizing radiation
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
Limitated to microwave and magnetotherapy medical devices 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/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), sterilisation with hydrogen peroxide, thermic sterilisation with dry heat.
*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