ANNEX ISupplementary provisions
ANNEX I The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE A. Active devices 1. Active implantable devices MDA CODE Active implantable devices MDA 0101 Active implantable devices for stimulation/inhibition/monitoring MDA 0102 Active implantable devices delivering drugs or other substances MDA 0103 Active implantable devices supporting or replacing organ functions MDA 0104 Active implantable devices utilising radiation and other active implantable devices 2. Active non-implantable devices for imaging, monitoring and/or diagnosis MDA CODE Active non-implantable devices for imaging, monitoring and/or diagnosis MDA 0201 Active non-implantable imaging devices utilising ionizing radiation MDA 0202 Active non-implantable imaging devices utilising non-ionizing radiation MDA 0203 Active non-implantable devices for monitoring of vital physiological parameters MDA 0204 Other active non-implantable devices for monitoring and/or diagnosis 3. Active non-implantable therapeutic devices and general active non-implantable devices MDA CODE Active non-implantable therapeutic devices and general active non-implantable devices MDA 0301 Active non-implantable devices utilising ionizing radiation MDA 0302 Active non-implantable devices utilising non-ionizing radiation MDA 0303 Active non-implantable devices utilising hyperthermia/hypothermia MDA 0304 Active non-implantable devices for shock-wave therapy (lithotripsy) MDA 0305 Active non-implantable devices for stimulation or inhibition MDA 0306 Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis MDA 0307 Active non-implantable respiratory devices MDA 0308 Active non-implantable devices for wound and skin care MDA 0309 Active non-implantable ophthalmologic devices MDA 0310 Active non-implantable devices for ear, nose and throat MDA 0311 Active non-implantable dental devices MDA 0312 Other active non-implantable surgical devices MDA 0313 Active non-implantable prostheses, devices for rehabilitation and devices for patient positioning and transport MDA 0314 Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART) MDA 0315 Software MDA 0316 Medical gas supply systems and parts thereof MDA 0317 Active non-implantable devices for cleaning, disinfection and sterilisation MDA 0318 Other active non-implantable devices B. Non-active devices 1. Non-active implants and long term surgically invasive devices MDN CODE Non-active implants and long term surgically invasive devices MDN 1101 Non-active cardiovascular, vascular and neurovascular implants MDN 1102 Non-active osteo- and orthopaedic implants MDN 1103 Non-active dental implants and dental materials MDN 1104 Non-active soft tissue and other implants 2. Non-active non-implantable devices MDN CODE Non-active non-implantable devices MDN 1201 Non-active non-implantable devices for anaesthesia, emergency and intensive care MDN 1202 Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis MDN 1203 Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools MDN 1204 Non-active non-implantable devices for wound and skin care MDN 1205 Non-active non-implantable orthopaedic and rehabilitation devices MDN 1206 Non-active non-implantable ophthalmologic devices MDN 1207 Non-active non-implantable diagnostic devices MDN 1208 Non-active non-implantable instruments MDN 1209 Non-active non-implantable dental materials MDN 1210 Non-active non-implantable devices used for contraception or prevention of the transmission of sexually transmitted diseases MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing 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) 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 MDN 1214 General non-active non-implantable devices used in health care and other non-active non-implantable devices II. HORIZONTAL CODES 1. Devices with specific characteristics MDS CODE Devices with specific characteristics MDS 1001 Devices incorporating medicinal substances MDS 1002 Devices manufactured utilising tissues or cells of human origin, or their derivatives MDS 1003 Devices manufactured utilising tissues or cells of animal origin, or their derivatives MDS 1004 Devices which are also machinery as defined in point (a) of the second paragraph of Article 2 of Directive 2006/42/EC of the European Parliament and of the Council ( 1 ) MDS 1005 Devices in sterile condition MDS 1006 Reusable surgical instruments MDS 1007 Devices incorporating or consisting of nanomaterial MDS 1008 Devices utilising biologically active coatings and/or materials or being wholly or mainly absorbed or locally dispersed in the human body or are intended to undergo a chemical change in the body MDS 1009 Devices incorporating software/utilising software/controlled by software, including devices intended for controlling, monitoring or directly influencing the performance of active or active implantable devices MDS 1010 Devices with a measuring function MDS 1011 Devices in systems or procedure packs MDS 1012 Products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 MDS 1013 Class III custom-made implantable devices MDS 1014 Devices incorporating as an integral part an in vitro diagnostic device 2. Devices for which specific technologies or processes are used MDT CODE Devices for which specific technologies or processes are used MDT 2001 Devices manufactured using metal processing MDT 2002 Devices manufactured using plastic processing MDT 2003 Devices manufactured using non-metal mineral processing (e.g. glass, ceramics) MDT 2004 Devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper) MDT 2005 Devices manufactured using biotechnology MDT 2006 Devices manufactured using chemical processing MDT 2007 Devices which require knowledge regarding the production of pharmaceuticals MDT 2008 Devices manufactured in clean rooms and associated controlled environments MDT 2009 Devices manufactured using processing of materials of human, animal, or microbial origin MDT 2010 Devices manufactured using electronic components including communication devices MDT 2011 Devices which require packaging, including labelling MDT 2012 Devices which require installation, refurbishment MDT 2013 Devices which have undergone reprocessing ( 1 ) Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast) ( OJ L 157, 9.6.2006, p. 24 ).