Regulation (EU) 2017/745 on medical devices 公告机构名单（四）

Regulation (EU) 2017/745 on medical devices 公告机构名单（4）
公告机构的名称和地址	公告号	产品	程序	条款/附录	条件
MDC MEDICAL DEVICE CERTIFICATIONGMBHKriegerstrasse  670191 STUTTGARTGermany+49:711:253597 0+49:711:253597 10mdc@mdc-ce.dehttp://www.mdc-ce.de	NB483	I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
		A. Active devices
		2. Active non-implantable devices for imaging, monitoring and/or diagnosis
		MDA 0201  Active non-implantable imaging devices utilising ionizing radiation	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0202  Active non-implantable imaging devices utilising non-ionizing radiation	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0203  Active non-implantable devices for monitoring of vital physiological parameters	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0204  Other active non-implantable devices for monitoring and/or diagnosis	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		3. Active non-implantable therapeutic devices and general active non-implantable devices
		MDA 0301  Active non-implantable devices utilising ionizing radiation	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0302  Active non-implantable devices utilising non-ionizing radiation	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0303  Active non-implantable devices utilising hyperthermia/hypothermia	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0305  Active non-implantable devices for stimulation or inhibition	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)	ExceptExternal pacemakers and heart defibrillators
		MDA 0306  Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0307  Active non-implantable respiratory devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)	Except hyperbaric chambers
		MDA 0308  Active non-implantable devices for wound and skin care	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0309  Active non-implantable ophthalmologic devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0310  Active non-implantable devices for ear, nose and throat	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0311  Active non-implantable dental devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0312  Other active non-implantable surgical devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0313  Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0314  Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)	excluding in vitro ferti¬lisation (IVF) and assisted reproductive technologies (ART)
		MDA 0315  Software	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0316  Medical gas supply systems and parts thereof	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0317  Active non-implantable devices for cleaning, disinfection and sterilisation	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDA 0318  Other active non-implantable devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		B. Non-active devices
		1. Non-active implants and long term surgically invasive devices
		MDN 1101  Non-active cardiovascular, vascular and neurovascular implants	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1102  Non-active osteo- and orthopaedic implants	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1103  Non-active dental implants and dental materials	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1104  Non-active soft tissue and other implants	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		2. Non-active non-implantable devices
		MDN 1201  Non-active non-implantable devices for anaesthesia, emergency and intensive care	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1202  Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1203  Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1204  Non-active non-implantable devices for wound and skin care	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1205  Non-active non-implantable orthopaedic and rehabilitation devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1206  Non-active non-implantable ophthalmologic devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1207  Non-active non-implantable diagnostic devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1208  Non-active non-implantable instruments	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1209  Non-active non-implantable dental materials	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1210  Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1211  Non-active non-implantable devices for disinfecting, cleaning and rinsing	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1212  Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1213  Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
		MDN 1214  General non-active non- implantable devices used in health care and other non-active non-implantable devices	Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance	Annex IX(I) Annex IX(II) Annex XI(A)
SLG PRÜF UND ZERTIFIZIERUNGSGMBHBurgstädter Strasse 2009232 HartmannsdorfGermany+49:3722:7323-0+49:3722:7323-899service@slg.de.comhttp://www.slg.de.com	NB494	I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
		A. Active devices
		2. Active non-implantable devices for imaging, monitoring and/or diagnosis
		MDA 0201  Active non-implantable imaging devices utilising ionizing radiation	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)	restricted to X-ray diagnostics, scintigraphy
		MDA 0203  Active non-implantable devices for monitoring of vital physiological parameters	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)
		MDA 0204  Other active non-implantable devices for monitoring and/or diagnosis	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)
		3. Active non-implantable therapeutic devices and general active non-implantable devices
		MDA 0302  Active non-implantable devices utilising non-ionizing radiation	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)
		MDA 0303  Active non-implantable devices utilising hyperthermia/hypothermia	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)	excluding devices forExternal whole- body hyperthermia therapy and hyperthermic perfusion
		MDA 0305  Active non-implantable devices for stimulation or inhibition	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)
		MDA 0307  Active non-implantable respiratory devices	Conformity assessment based on type-examination Conformity assessment based on a quality management system Conformity assessment based on assessment of technical documentation Conformity assessment based on product quality assurance Conformity assessment based on product conformity verification	Annex X Annex IX(I) Annex IX(II) Annex XI(A) Annex XI(B)	excluding devices forEmergency medicine and anesthesia