El Organismo Notificado español AEMPS ha comunicado en nota de prensa su renovación de la notificación como Organismo Notificado según la directiva 93/42/EEC acreditada por ENAC. La notificación aparece en NANDO con fecha 4 de Julio de 2018: http://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.nb&refe_cd=EPOS_43640
Estos son los códigos para los que esta notificado el ON 0318:
| 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 | |