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 : Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) Heinrich-Böll-Ring Bonn Germany 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 : TÜV Rheinland LGA Products GmbH Tillystraße Nürnberg Germany Phone : +49 (0) Fax : +49 (0) cert-validity@de.tuv.com Website : Body : NB 0197 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 12/10/2015 The body is assessed according to : Article 16 and Annex XI of Directive 93/42/EEC, Commission Implementing Regulation (EU) No 920/2013, MEDDEV 2.10/2 Designation and Monitoring of Notified Bodies within the Framework of the EC Directives on Medical Devices, Designating Authorities Handbook, DIN EN ISO/IEC : 2011 / : 2015, DIN EN ISO/IEC : 2013 The competence of the body was assessed by : ZLG 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 : 06/09/2016 Last update : 19/12/2016 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 ophthalmologic devices - *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 medical devices for ingestion (full quality assurance system) (production quality assurance) (product quality assurance) *MD Non-active implants - *MD Non-active cardiovascular implants - *MD Non-active orthopaedic implants - *MD Non-active functional implants - *MD Non-active soft tissue implants I I I I I I I I I I I I I I I I I I I 2 / 5

3 *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 - *MD Devices for stimulation or inhibition - *MD Active surgical devices - *MD Active ophthalmologic devices - *MD Active dental devices - *MD Active devices for disinfection and sterilisation I I I I I I I I I I I I I I I I I I I I I I 3 / 5

4 - *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 - *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 (full quality assurance system) (production quality assurance) (product quality assurance) *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising ionizing radiation - *MD Devices utilising non-ionizing radiation I I I I I I I I I I I I I I I I I I I I I 4 / 5

5 - *MD Devices for hyperthermia / hypothermia - *MD Devices for (extracorporal) shock-wave therapy (lithotripsy) 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 722/2012 (Directive 2003/32/EC up to ) *MDS Medical devices referencing the Directive 2006/42/EC on machinery for active medical devices only *MDS Medical devices in sterile condition Including aseptic processing, ethylene oxide gas sterilisation (EOG), moist heat sterilisation, radiation sterilisation (gamma, electron beam), low temperature steam and formaldehyde sterilisation, sterilisation with hydrogen peroxide, thermic sterilisation with dry heat, sterilisation by liquid chemical sterilants *MDS Medical devices utilising micromechanics *MDS Medical devices utilising nanomaterials *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 5 / 5