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 : MEDCERT ZERTIFIZIERUNGS- UND PRÜFUNGSGESELLSCHAFT FÜR DIE MEDIZIN GMBH Pilatuspool HAMBURG Germany Phone : +49:40: Fax : +49:40: info@medcert.de Website : Body : NB 0482 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 08/09/2010 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 and Joint Assessment Team according to Commission Implementing Regulation (EU) No 920/2013 The assessment of the body covers the product categories and conformity assessment procedures concerned by this notification : Yes 1 / 6

2 Tasks performed by the Body : Created : 18/05/2015 Last update : 28/07/2016 Product family, product /Intended use/product *MD General non-active, non-implantable medical devices - *MD Non-active devices for anaesthesia, emergency and intensive care EC type-examination - *MD Non-active devices for injection, infusion, EC type-examination 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 EC type-examination - *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 I I I 2 / 6

3 Product family, product /Intended use/product *MD Non-active implants - *MD Non-active cardiovascular implants EC type-examination - *MD Non-active orthopaedic implants - *MD Non-active functional implants EC type-examination - *MD Non-active soft tissue implants *MD Devices for wound care - *MD Bandages and wound dressings EC type-examination - *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 EC type-examination I I I I 3 / 6

4 Product family, product /Intended use/product *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 - *MD Active rehabilitation devices and active prostheses - *MD Active devices for patient positioning and transport - *MD Software - *MD Medical gas supply systems and parts thereof *MD Devices for imaging 4 / 6

5 Product family, product /Intended use/product - *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 *MD Devices for radiation therapy and thermo therapy - *MD Devices utilising ionizing radiation - *MD Devices utilising non-ionizing radiation - *MD Devices for hyperthermia / hypothermia - *MD Devices for (extracorporal) shock-wave therapy (lithotripsy) 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, x-ray, electron beam), low temperature steam and formaldehyde sterilisation, sterilisation with hydrogen peroxide, thermic sterilisation with dry heat *MDS Medical devices utilising micromechanics 5 / 6

6 Horizontal technical competence *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 6 / 6