| Regulation (EU) 2017/745 on medical devices 公告机构名单（3） |
| 公告机构的名称和地址 |
公告号 |
产品 |
程序 |
条款/附录 |
条件 |
DQS Medizinprodukte GmbH
August-Schanz-Straße 21
60433 FRANKFURT AM MAIN
Germany
+49 69 95427 300
+49 69 95427 388
medizinprodukte@dqs-med.de
www.dqsglobal.com/de-
de/zertifizieren/verordnung-mdr-eu-
2017-745 |
NB297 |
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE |
|
|
|
|
|
A. Active devices |
|
|
|
|
|
1. Active implantable devices |
|
|
|
|
|
MDA 0101 Active implantable devices for stimulation/inhibition/monitoring |
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation |
Annex IX(I)
Annex IX(II) |
restricted to active implantable devices for cardiovascular/vas cular stimulation / inhibition / monitoring |
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
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 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) |
|
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
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 0304 Active non-implantable devices for shock-wave therapy (lithotripsy) |
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation |
Annex IX(I)
Annex IX(II) |
|
|
|
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) |
|
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
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) |
restricted toExternal hearing aids |
|
|
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 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) |
|
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
MDN 1102 Non-active osteo- and orthopaedic implants |
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation |
Annex IX(I)
Annex IX(II) |
|
|
|
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 |
Annex IX(I)
Annex IX(II) |
|
|
|
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 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 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) |
|
| SZUTESTKonformitätsbewertungsstelle GmbHFriedrich-Ebert-Anlage 36D-60325 Frankfurt am MainGermany+49 69 244 333 026info@szutest-germany.dehttp://www.szutest-germany.de |
NB2975 |
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 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 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 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) |
|
|
|
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) |
|
|
|
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 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 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 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 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 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) |
|
Scarlet NB B.V.
Keizersgracht 555, 1017 DR
Amsterdam
Netherlands
+31 202409000
+44 20 4520 3023
regulatory@scarletcomply.com
www.scarlet.cc |
NB3022 |
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE |
|
|
|
|
|
A. Active devices |
|
|
|
|
|
3. Active non-implantable therapeutic devices and general active non-implantable devices |
|
|
|
|
|
MDA 0315 Software |
Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation |
Annex IX(I)
Annex IX(II) |
|
RISE Medical Notified Body AB
Isafjordsgatan 22 / P.O. Box 857
164 40 Kista / SE-501 15 Borås
Sweden
+46 10 516 67 00
mnb@ri.se
www.ri.se/sv/mnb |
NB3033 |
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 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) |
Class IIIExcluded,EEGExcluded |
|
|
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) |
Class IIIExcluded |
|
|
3. Active non-implantable therapeutic devices and general active non-implantable devices |
|
|
|
|
|
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) |
Class IIIExcluded, Short wave diathermyExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded, Heart-lung-bypass pump/ExtracorporEal Membrane Oxygenation (ECMO)Excluded, Intra-aorthic Balloon PumpExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded, Restricted to: Powered dental surgical unit and hand pieces, Surgical suction device for dental use |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded |
|
|
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) |
Class IIIExcluded, Medical gas pipeline systemExcluded |
|
|
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) |
Class IIIExcluded, Sterilization devicesExcluded |
|
|
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) |
Class IIIExcluded |
|
|
B. Non-active devices |
|
|
|
|
|
1. Non-active implants and long term surgically invasive devices |
|
|
|
|
|
