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

Size: px

Start display at page:

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

Clinton Heath
5 years ago
Views:

1 Notification of a Body in the framework of a technical harmonization directive From : Ministry of Health ul. Miodowa Warszawa Poland 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 : POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. ul. Klobucka 23A Warszawa Poland Phone : Fax : pcbc@pcbc.gov.pl Website : Body : NB 1434 Created : Unknown (Notifications pre-dating 2006 are not available in these lists) Last update : 13/05/2016 The body is assessed according to : EN EN ISO/IEC EN EN ISO/IEC EN EN ISO/IEC The competence of the body was assessed by : Minister of Health 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 : 21/07/2017 Last update : 21/07/2017 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 2 / 6

3 - *MD Non-active medical devices for ingestion *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 *MD Devices for wound care - *MD Bandages and wound dressings - *MD Suture material and clamps - *MD Other medical devices for wound care 3 / 6

4 *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 4 / 6

5 - *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 - *MD Imaging devices utilising ionizing radiation - *MD Imaging devices utilising non-ionizing radiation 5 / 6

6 *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 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 incorporating derivates of human blood, according to Directive 2000/70/EC, amended by Directive 2001/104/EC *MDS Medical devices referencing the Directive 2006/42/EC on machinery *MDS Medical devices in sterile condition *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 6 / 6

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

Notification of a Body in the framework of a technical harmonization directive From : National Organization for Medicines (EOF) Mesogeion 284, 155 62 Holargos Greece To : European Commission GROWTH Directorate-General