Notification of a Body in the framework of a technical harmonization directive

Transcription

1 Notification of a Body in the framework of a technical harmonization directive From : National Institute of Pharmacy and Nutrition (OGYÉI) Zrínyi u. 3. H-1051 Budapest Hungary To : European Commission GROWTH Directorate-General 200 Rue de la Loi, B-1049 Brussels. Other Member States Reference : Legislation : 93/42/EEC Medical devices Body name, address, telephone, fax, , website : Országos Gógyszerészeti és Élelmezés-egészségügyi Intézet Eszközmin#sít# és Kórháztechnikai Igazgatóság (National Institute of Pharmacy and Nutrition) Zrínyi u. 3 H-1051 Budapest Hungary Phone : (+361) Fax : (+361) cert@emki.hu Website : Body : NB 1011 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 15/06/2015 The body is assessed according to : EU Regulation 920/2013, Directive 93/42/EEC, national legislation 4/2009 (III. 17.) Decree of the Minister of Health, 18/2010 (IV. 20.) Decree of the Minister of Health, Designating Authorities Handbook and guidelines The competence of the body was assessed by : National Institute of Pharmacy and Nutrition (OGYEI) The assessment of the body covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 5

2 Tasks performed by the Body : Created : 29/06/2018 Last update : 29/06/2018 Product family, product /Intended use/product *MD General non-active, non-implantable medical devices - *MD Non-active devices for anaesthesia, emergency and intensive care - *MD Non-active devices for injection, infusion, transfusion and dialysis - *MD Non-active orthopaedic and rehabilitation devices - *MD Non-active medical devices with measuring function - *MD Non-active instruments - *MD Contraceptive medical devices - *MD Non-active medical devices for disinfecting, cleaning, rinsing - *MD Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART) *MD Non-active implants - *MD Non-active orthopaedic implants I I I I I I I I I I I I I I I I I I. designation excluding materials of desinfecting, cleaning and rinsing. For., V., VI. there are no limitations. 2 / 5

3 - *MD Non-active functional implants - *MD Non-active soft tissue implants *MD Devices for wound care - *MD Bandages and wound dressings - *MD Suture material and clamps - *MD Other medical devices for wound care *MD Non-active dental devices and accessories - *MD Non-active dental equipment and instruments - *MD Dental materials - *MD Dental implants *MD General active medical devices - *MD Devices for extra-corporal circulation, infusion and haemopheresis - *MD Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia I I I I I I I I I I I I I I I - *MD Devices for stimulation or inhibition I Excluding breast and body shaping implants 3 / 5

4 - *MD Active surgical devices - *MD Active dental devices - *MD Active devices for disinfection and sterilisation - *MD Active rehabilitation devices and active prostheses - *MD Active devices for patient positioning and transport - *MD Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART) - *MD Software - *MD Medical gas supply systems and parts thereof *MD Devices for imaging - *MD Imaging devices utilising ionizing radiation I I I I I I I I I I I I I I I I I 4 / 5

5 - *MD Imaging devices utilising non-ionizing radiation *MD Monitoring devices - *MD Monitoring devices of non-vital physiological parameters - *MD Monitoring devices of vital physiological parameters *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia I I I I I I I I I I Horizontal technical competence *MDS Medical devices incorporating medicinal substances, according to Directive 2001/83/EC *MDS Medical devices utilising tissues of animal origin, including Regulation Designation excludes products related 722/2012 (Directive 2003/32/EC up to ) 2003/32/EC BSE/TSE field. Designation includes Annex 2 and 5. *MDS Medical devices referencing the Directive 2006/42/EC on machinery *MDS Medical devices in sterile condition *MDS Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed *MDS Medical devices incorporating software /utilising software /controlled by software Including aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation 5 / 5