GUIDANCE

GUIDANCE

CODES ASSIGNMENT REFERRED

TO IN THE IMPLEMENTING
REGULATION 2017/2185
IN THE CONTEXT OF A REQUEST
FOR CERTIFICATION ACCORDING
TO THE REGULATION (EU) 2017/745

MARCH 2020 EDITION

GUIDANCE FOR USE BY GMED CUSTOMERS ONLY

GMED property document - RDM 0701-89a rev 0 - 11/03/2020
ANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

TABLE OF CONTENTS
MARCH 2020 EDITION

I CONTEXT 3 B NON-ACTIVE DEVICES CODES 10

1 Non-active implants and long

II METHOD FOR THE

ASSIGNMENT OF CODES 3 term surgically invasive devices 10

2 Non-active non-implantable devices 11

1 MDA/MDN Codes 3

2 MDS Codes 4 C HORIZONTAL CODES 13

3 MDT Codes 4
1 Devices with specific characteristics 13
4 Overview 6
2 Devices for which specific technologies
or processes are used 15

III EASSIGNMENT
XAMPLES FOR CODES
6
A ACTIVE DEVICES CODES 6

1 Active implantable devices 6

2 Active non-implantable devices

for imaging, monitoring
and / or diagnosis 7

3 Active non-implantable therapeutic

devices and general active
non-implantable devices 8

GUIDANCE FOR USE BY GMED CUSTOMERS ONLY

GMED property document - RDM 0701-89a rev 0 - 11/03/2020
GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

I CONTEXT 1 MDA/MDN Codes

MDA / MDN-codes reflect the design and intended
Commission Implementing Regulation 2017/2185 purpose of the device. Only one code must be assigned
establishes the codes for the definition of notified bod- to each device. In the case where several codes are
ies’ scope of designation in medical devices under Reg- applicable, the highest code in the list of Regulation
ulation (EU) 2017/745. 2017/2185 must be assigned.

In order to determine whether the request for certifica-

tion within the framework of a CE marking according to EXAMPLE : A surgical laser for refractive sur-
Regulation 2017/745 is eligible compared to the desig- gery of the eye is assigned to “MDA 0302 Active
nation codes for which GMED is designated as a noti- non-implantable devices utilising non-ionizing
fied body, the manufacturer must describe the type of radiation” and not to “MDA 0309 Active non-
device and technology concerned and identify the cor- implantable ophthalmologic devices” because,
responding codes. even though both codes are specific for the device,
since MDA 0302 is higher in the list.
The assigned codes are then verified by GMED to
ensure their coherency in view of the design and
intended purpose of the device and the technologies
and processes used. Devices may be composed of different components
which, if they were products on their own, would
The purpose of this guide is to clarify the different belong to different MDA/MDN codes. In such cases,
types of codes and their method of assignment in the intended purpose or the main physical or techno-
order to ensure the consistency of the codes assigned logical principle of the device should be considered.
to a type of medical device.

This guide is based on the document MDCG 2019-14, EXAMPLE : A medical devices is composed of a
Explanatory note on MDR codes of December 2019, suture anchor (a bone screw attached to a surgi-
available on the European Commission website cal suture to reattach ruptured tendons) as well
(https://ec.europa.eu). as a single use deployment instrument and a sin-
gle use bone drill. The components are provided
sterile in a blister, are covered by the same techni-
cal documentation and are not available individu-
ally. This product is assigned to “MDN 1102 Non-
II 
METHOD FOR THE ASSIGNMENT active osteo- and orthopaedic implants” and not
OF CODES to “MDN 1208 Non-active non-implantable instru-
ments” because the implanted component of the
device is associated with the intended purpose
The Implementing Regulation 2017/2185 defines three rather than the deployment instrument and the
types of codes: drill.
• MDA/MDN codes: Codes reflecting the design and
intended purpose of the device,
• MDS codes: Horizontal codes reflecting the specific
characteristics of the device,
• MDT codes: Horizontal codes describing the technol-
ogies or processes used.

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

In certain exceptional cases, GMED may have to

deviate from the above-mentioned rule so that EXEMPLE : A partially resorbable, sterile surgical
the code assigned reflects the risk linked to the implant that contains an antibiotic to prevent post-
most critical technology (in particular in terms surgical infection will need to be assigned to the fol-
of skills associated to carry out the conformity lowing MDS codes:
assessment). This aspect is then discussed by • “MDS 1005 - Devices in sterile condition”: because
the different parties and a justification for the it is provided sterile,
choice made is documented by GMED. • “MDS 1008 - Devices utilising [...] being wholly or
mainly absorbed or locally dispersed in the human
body […]”: because it is absorbed, and
EXEMPLE : A heater-cooler unit (HCU) for • “MDS 1001 - Devices incorporating medicinal sub-
cardiac surgery is a device through which blood cir- stances”: because it contains an antibiotic.
culates, and which changes the circulating blood’s
temperature in order to achieve hypo- or hyper-
thermia. Both the codes “MDA 0303 Active non-
implantable devices utilising hyperthermia/hypo-
thermia” and “MDA 0306 Active non-implantable
devices for extra-corporal circulation, administra- 3 MDT Codes
tion or removal of substances and haemapheresis”
are specific to the device. Since MDA 0303 is a code MDT codes are horizontal codes associated with the
higher in the list, according to the rule explained technologies or processes used in the manufacturing
above it should be chosen. Nonetheless, it was and making available of the devices.
decided to assign the code MDA 0306 by docu-
menting that the highest risks associated with HCU Assignment of MDT codes should be done taking into
are mainly linked to this code. consideration production of the device itself as well as
for critical production steps. This means that only crit-
ical processes are to be considered.
Two specific cases are identified for which a clear The processes considered critical by GMED are the
assignment is given: internal and/or subcontracted manufacturing process-
• Stand-alone software should be assigned to the code es having the most impact on the performance and
MDA 0315. safety of medical devices. The same process can be
• Non-implantable cardiovascular catheters, guide- considered as critical or non-critical depending on the
wires, introducers, filters and related tools are to be type of device concerned. For illustration, the prima-
assigned to the code MDN 1203. ry packaging process for a sterile product will be crit-
ical, which is not necessarily the case for a non-ster-
ile product. Or the injection method of an implantable
part will be critical, which will not necessarily be the
2 MDS Codes case of the injection method for a protective casing of
electro-medical equipment.
MDS codes are horizontal codes which reflect the spe-
cific characteristics of the device. All applicable codes
must be assigned to a device.

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

EXAMPLE : An electronic medical thermometer

for layman’s use should be assigned to the follow-
ing MDT codes:
• “MDT 2010 Devices manufactured using elec-
tronic components including communication
devices” because the product is assembled from
electronic components and
• “MDT 2011 Devices which require packaging,
including labelling” because the device is packed
and labelled.

It is important to note that the MDT codes are assigned

to the devices, whether the manufacturing or making
available activities are carried out by the manufacturer
himself or that they are subcontracted.

EXAMPLE : A manufacturer of cross-linked hya-

luronic acid implants has no in-house manufactur-
ing. The finished, labelled implant is bought from
a supplier. The implant raw material (hyaluronic
acid) is produced by fermentation using bacteria.
The following MDT codes should be assigned:
• “MDT 2008 Devices manufactured in clean
rooms and associated controlled environments”,
because the manufacturing of the implant is in a
controlled environment,
• “MDT 2005 Devices manufactured using bio-
technology”, because the main risks in man-
ufacturing are related to the production and
cross-linking of the hyaluronic acid.
• “MDT 2011 Devices which require packag-
ing, including labelling” because the implant is
packed and labelled.

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

4 Overview
MARCH 2020 EDITION

The assignment of codes is carried out by following the steps below using the list of codes as published in the
Implementing Regulation (EU) 2017/2185 of November 23, 2017.

CODE CODE type ASSIGNATION DES CODES

A UN DISPOSITIF

Exactly 1 code per device

The codes should be assigned according
Codes reflecting the design and to their hierarchical order in Regulation
1ST STAGE MDA/MDN intended purpose of the device. 2017/2185.
If more than one MDA/ MDN code is
applicable, the one that is highest in the
list should be selected.

Codes reflecting the specific Between 0 to several per device

2ND STAGE MDS characteristics of the device. Assign all codes applicable to the device.

Between 1 to several per device

Horizontal codes describing the Assign the codes which describe the
3 RD
STAGE MDT technologies or processes used. main production technologies or critical
processes.

III EXAMPLES FOR CODES ASSIGNMENT

A Active devices codes

1 Active implantable devices

ACTIVE IMPLANTABLE DEVICES

MDA CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

• Implantable cardiac defibrillators

• Implantable endocardial bipolar pacing lead
Active implantable devices • Implantable pacemaker
MDA 0101 for stimulation / inhibition / • Neuro-stimulators
monitoring • Diaphragm stimulator
• Implantable bladder stimulator
• Implantable artificial sphincter

Active implantable devices

MDA 0102 delivering drugs or other • Implantable pumps (insulin…)
substances

Active implantable devices • Cochlear implant

• Brainstem implant
MDA 0103 supporting or replacing organ • Motorized gastric bands
functions • Artificial heart

Active implantable devices

MDA 0104 utilising radiation and other • Radioactive seeds implant
active implantable devices

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

2 Active non-implantable devices for imaging, monitoring and / or diagnosis

ACTIVE NON-IMPLANTABLE DEVICES FOR IMAGING, MONITORING AND / OR DIAGNOSIS

MDA CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

• Devices for radiology and tomography

• Nuclear medicine workstation for nuclear medicine diagnostic
imaging system
Active non-implantable imaging • PET/SPECT imaging system
MDA 0201 devices utilising ionizing radiation • Mammographic systems
• X-ray tube
• Gamma cameras
• Fluoroscopy equipment

Active non-implantable imaging • MRI

• Near-infrared spectroscopic imaging
MDA 0202 devices utilising non-ionizing • Optical tomography
radiation • Optical imaging system

• Respiratory Polygraph, apnea monitors

• Devices for ECG/ EEG
Active non-implantable • Oximetry sensor
MDA 0203 devices for monitoring of vital • Aneroid sphygmomanometer/tensiometer
physiological parameters • Electronic thermometers
• Devices for hemodynamic measurement
• Spirometer

• Polysomnograph
• Ultrasound diagnostics devices and associated probes /
Echographs
Other active non-implantable • Digital manometers
• Connected insole
MDA 0204 devices for monitoring and / or • Curameters
diagnosis • Devices for the diagnostic of visual functions (pupillometers,
refractometers, tonometers, pachymeters, topgraphers,
aberrometers)
• Devices for the diagnostic of hearing functions

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

3 ACTIVE NON-IMPLANTABLE THERAPEUTIC DEVICES AND GENERAL ACTIVE

NON-IMPLANTABLE DEVICES
ACTIVE NON-IMPLANTABLE THERAPEUTIC DEVICES AND GENERAL ACTIVE NON-IMPLANTABLE DEVICES

MDA CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

Active non-implantable devices • Therapeutic cyclotrons and linear accelerator

MDA 0301 utilising ionizing radiation • Radiotherapy equipment

• Remote transmitter for implantable cardiac devices (radio

Active non-implantable devices frequency)
MDA 0302 utilising non-ionizing radiation • Phototherapy devices
• Surgical laser for refractive surgery of the eye
• Laser for pain treatment

• Devices in the treatment of venous disease by endothermal

Active non-implantable devices techniques
MDA 0303 utilising hyperthermia / • Devices for patient heating (heating blankets, heating cradles…)
hypothermia • Cryotherapy equipment
• Paraffin bath

Active non-implantable devices

MDA 0304 for shock-wave therapy • Extracorporeal lithotripters
(lithotripsy)

• Automated external defibrillator

• Nerve stimulation devices
Active non-implantable devices • Muscle stimulators
MDA 0305 for stimulation or inhibition • Electrostimulators for treatment of urinary incontinence
• Ionopheresis treatment device
• Electrical acupuncture
• External bone growth stimulators

• Hemodialysis devices
• Infusion pumps
Active non-implantable devices • Electric breast pump
for extra-corporal circulation, • Hardware and software for incorporating into infusion pump to
MDA 0306 administration or removal of control the administration of anesthetic agent
substances and haemapheresis • Anesthesia workstation (manifold block, syringes pumps, gas
mixers…)
• Jet injectors for vaccination
• Blood pumps for heart-lung machines

• Devices for ventilation, oxygen-therapy and for the treatment of

Active non-implantable sleep apnea.
MDA 0307 respiratory devices • Devices for functional respiratory exploration
• Hyperbaric chamber
• Nebulisers

• Wound treatment devices

Active non-implantable devices • Mesotherapy devices
MDA 0308 for wound and skin care • Pressotherapy/Vacuometry devices
• Water jet for wound debridement

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745
MARCH 2020 EDITION

Active non-implantable therapeutic devices and general active

non-implantable device (afterpart)
ACTIVE NON-IMPLANTABLE THERAPEUTIC DEVICES AND GENERAL ACTIVE NON-IMPLANTABLE DEVICES

MDA CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

Active non-implantable • Electromagnet for Eye Surgery

MDA 0309 ophthalmologic devices • Ultrasound probe for phacoemulsification (cataract treatment)
• Aspiration pump for ophtalmological use

Active non-implantable devices

MDA 0310 for ear, nose and throat • Hearing aids

• Dental drills
• Surgical suction device for dental use
Active non-implantable dental • Ultrasonic scalers
MDA 0311 devices • Chairs with equipment
• Apex locator
• Endodontology microengine

• RF Electrosurgical equipment
• Electrosurgery instruments
Other active non-implantable • Robotic high intensity ultrasound therapy equipment
MDA 0312 surgical devices • Computer assisted surgical devices
• Laparoscopic insufflator
• Cauterization devices

Active non-implantable • Active medical beds and wheelchairs

prostheses, devices for • Immobilization, mobilization and testing devices of the human
MDA 0313 rehabilitation and devices for joints
patient positioning and transport • Patient lift
• Exoskeleton

Active non-implantable devices

for processing and preserva¬tion • Cryobiological storage container
of human cells, tissues or organs • IVF cryopreservation systems
MDA 0314 including in vitro ferti¬lisation • Blood bank refrigerator
(IVF) and assisted reproductive
technologies (ART)

• Data conversion software

• Monitoring software
MDA 0315 Software • Pre-implant planning software for surgery
• Medical imaging software

Medical gas supply systems and • Medical gas supply system in a hospital
MDA 0316 parts thereof • Gas manifold and line pressure regulator for medical regulators

Active non-implantable devices • Disinfecting chambers using for MD

MDA 0317 for cleaning, disinfection and • Steam cleaner and disinfector for MD
sterilisation

Other active non-implantable • Electronic tourniquets

MDA 0318 devices • Devices for electrotherapy/magnetotherapy
• Surgical tables

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CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR MARCH 2020 EDITION
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

B Non-active devices codes

1 Non-active implants and long term surgically invasive devices

NON-ACTIVE IMPLANTS AND LONG TERM SURGICALLY INVASIVE DEVICES

MDN CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

• Vascular prosthesis, stents

• Heart valves, heart prosthesis, annuloplasty rings
Non-active cardiovascular, • Valves and catheters for hydrocephalus
• Embolization agent, glue
MDN 1101 vascular and neurovascular • Implant for the treatment of intracranial aneurysm
implants • Vena cava filter
• Vascular implantable ports, vascular implantable catheters
• Sutures for cardiovascular surgery

• Artificial spinal disc

• Spinal cage
• Orthopedic cement
• Orthopedic implants (shoulders, knees, hips, spine...)
Non-active osteo- and • Implants for osseous filling, for osteotomy
MDN 1102 orthopaedic implants • Hyaluronic acid implant for intra-articular use
• Bone substitute
• Orthopedic nails, plates, screws
• Sutures, suture anchors, staples for orthopedic surgery
• Artificial ligaments
• Medullary plugs

• Dental implants
Non-active dental implants and • Dental fillers
MDN 1103 dental materials • Root canal filler
• Abutments

• Tissue or organs support and reinforcements (mesh)

• Implants for urological surgery (ureteral stent…)
• Cosmetic implants (breast, calves, pecs, penis...)
• Staples, clips, sutures (not falling in above codes)
• Hyaluronic acid dermal fillers
Non-active soft tissue and other • Intraocular lens and phacoemulsification
MDN 1104 implants • Intra-uterine device – IUD
• Eyelid implant
• Bariatric surgery devices: Gastric rings, gastric balloons, gastric
bands…
• Biliary stents, pharyngeal stents
• Lung volume reduction devices: coils, valves, sealants.
• Implantable ports (excluding vascular) solution

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

2 Non-active non-implantable devices

MARCH 2020 EDITION

NON-ACTIVE NON-IMPLANTABLE DEVICES

MDN CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

• Devices for tracheostomy and laryngectomy

Non-active non-implantable • Masks, breathing balls and ventilation circuits
MDN 1201 devices for anesthesia, • Devices for pleural drainage
emergency and intensive care • Devices for anesthesia - intensive care
• Cryoanesthesic agents

• Hemodialysis kits : filter, solution

Non-active non-implantable • Needles
devices for administration, • Devices for infusion, for puncture
MDN 1202 channelling and removal of • Epidural catheters, urinary catheter
substances, including devices for • Dosing spoons
dialysis • Syringes
• Manual breast pump

Non-active non-implantable • Vascular filter catheter

guide catheters, balloon • Embolectomy catheter
MDN 1203 catheters, guidewires, • Cardiovascular guidewires and catheters
introducers, filters, and related • Neurovascular catheters
tools • Central venous catheter

• Dressings, compresses
• Liquid dressings
Non-active non-implantable • Solutions for wound care (Eosin 2%, NaCl...)
MDN 1204 devices for wound and skin care • Fat tulle
• Devices in the form of cream: healing, treatment of hemorrhoids
• Sutures for dermal wound closure (<30 days)
• Surgical gloves

• Orthosis, corsets, orthopedic soles, lumbar and abdominal

Non-active non-implantable bearing belts, cervical collar
MDN 1205 orthopaedic and rehabilitation • Crutches
devices • Wheelchairs
• Ancillaries, trial implants

• Solutions for ophthalmic rinsing

• Solutions for hydration/lubrication of the eye
Non-active non-implantable • Systems for implants injection for ophthalmology
MDN 1206 ophthalmologic devices • Contact lenses and rinse solution
• Instruments for ophalmologic surgery
• Iris retractor

Non-active non-implantable • Recording chart paper for physiological waveform

MDN 1207 diagnostic devices • Thermal expansion thermometer

Non-active non-implantable • Surgical devices (Pliers, loops, scalpels, trocars…)

MDN 1208 instruments • Surgical kits

• Gingival retraction cord

• Devices for orthodontics
• Dental impression material
Non-active non-implantable • Dental adhesive
MDN 1209 dental materials • Etching solution for dental use
• Braces
• Dental cements (when not considered long term surgically
invasive)

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

Non-active non-implantable devices (afterpart)

MARCH 2020 EDITION

NON-ACTIVE NON-IMPLANTABLE DEVICES

MDN CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

Non-active non-implantable
devices used for contraception or • Condoms
MDN 1210 prevention of the transmission of • Contraceptive diaphragms
sexually transmitted diseases

Non-active non-implantable • Disinfectant solutions

MDN 1211 devices for disinfecting, cleaning • Disinfectant wipes
and rinsing

• Bag for organ transport and refrigeration

• Organ preservation solutions
Non-active non-implantable • Blood platelet storage solutions
devices for processing and • Pocket systems for cord blood and / or stem cells, phlebotomy
pre¬servation of human cells, bags
MDN 1212 tissue or organs including in vitro • Blood bags
fertilization (IVF) and assisted • Freezing solution for egg cells
reproductive technologies (ART) • Embryo transfer catheters
• Artificial insemination probes
• Devices for oocyte and sperm preservation

Non-active non-implantable
devices composed of substances • Nasal, auricular, oral solution (single dose, spray ...)
MDN 1213 to be introduced into the human • Devices in the form of suppositories
body via a body orifice or the • Devices for oral care
dermal route

General non-active non- • Warming relaxing patch

implantable devices used in • Surgical drapes
MDN 1214 health care and other non-active • Acupuncture needles
non-implantable devices • Tubes (feeding…)
• Ultrasound gels

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

C Horizontal codes
MARCH 2020 EDITION

1 Devices with specific characteristics

DEVICES WITH SPECIFIC CHARACTERISTICS

MDS CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

Devices incorporating medicinal • Hormonal intra-uterine devices

MDS 1001 substances • Chlorhexidine dressing
• Heparin coated vascular prosthesis

Devices manufactured utilising • Tissue engineering products from tissues of human origin
MDS 1002 tissues or cells of human origin, (bone…)
or their derivatives

Devices manufactured utilising • Bone substitute

MDS 1003 tissues or cells of animal origin, or • Xenogeneic heart valves
their derivatives • Matric for dermal regeneration

Devices which are also machinery

as defined in point (a) of the • Medical robot
second paragraph of Article 2
MDS 1004 of Directive 2006/42/EC of the • Electronic wheelchair
European Parliament and of the • Scanner
Council

MDS 1005 Devices in sterile condition • Devices sterilized by ETO, radiation, steam, aseptic filtration…

• Biomedical equipment
MDS 1006 Reusable surgical instruments • Surgical instruments

Devices incorporating or
MDS 1007 consisting of nanomaterial • Devices made of nanomaterials (implants, needle, trocar ...)

Devices utilising biologically

active coatings and / or materials • Joint implants covered with hydroxyapatite
or being wholly or mainly • Reinforcement implant covered with collagen
MDS 1008 absorbed or locally dispersed in • Medullary plugs
the human body or are intended • Absorbable sutures
to undergo a chemical change in
the body

Devices incorporating software /

utilising software / controlled
by software, including devices
MDS 1009 intended for controlling, • Devices linked to a software
monitoring or directly influencing
the performance of active or
active implantable devices

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

Devices with specific characteristics (afterpart)

MARCH 2020 EDITION

DEVICES WITH SPECIFIC CHARACTERISTICS

MDS CODE CORRESPONDING TYPES EXAMPLES OF DEVICES COVERED

OF DEVICES

Devices with a measuring • Measuring spoons

MDS 1010 function • Recording chart paper for physiological waveform
• Measuring syringes

Devices in systems or • Nutrition / respiratory systems

MDS 1011 procedure packs • Care sets

Products without an intended • Color contact lens

• Body implants
MDS 1012 medical purpose listed in Annex • Pre-filled syringe for filling wrinkles
XVI to Regulation (EU) 2017/745 • Aspiration for liposuction

Class III custom-made • Custom-made orthopedic implants

MDS 1013 implantable devices • Orthodontic appliance

Devices incorporating as
MDS 1014 an integral part an in vitro • Dialysis device incorporating a device for measuring creatinine
diagnostic device

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GUIDANCE
CODES ASSIGNMENT REFERRED TO IN THE IMPLEMENTING
REGULATION 2017/2185 IN THE CONTEXT OF A REQUEST FOR
CERTIFICATION ACCORDING TO THE REGULATION (UE) 2017/745

2 Devices for which specific technologies or processes are used

MARCH 2020 EDITION

DEVICES FOR WHICH SPECIFIC TECHNOLOGIES OR PROCESSES ARE USED

MDT CODE CORRESPONDING TYPES DEVICE MANUFACTURING TECHNOLOGIES

OF DEVICES

Devices manufactured using • 3D printing (metal), casting, welding

MDT 2001 metal processing • Turning (metal), anodization, passivation, polishing, surface
modification, laser tube cutting, honing

Devices manufactured using • Injection molding, extrusion, bonding

MDT 2002 plastic processing • Polymer compounding, 3D printing (plastics), thermoforming,
blow molding, turning (plastics)

Devices manufactured using non-

MDT 2003 metal mineral processing (e.g. • Ceramic sintering, ceramic compounding
glass, ceramics)

Devices manufactured using non-

metal non-mineral processing
MDT 2004 (e.g. textiles, rubber, leather, • Weaving, knitting
paper)

Devices manufactured using • Fermentation using cell cultures, enzymatic production

MDT 2005 biotechnology processes, purification and modification of biomolecules

Devices manufactured using

MDT 2006 chemical processing • Compounding, buffering

Devices which require knowledge • Production, handling and incorporation into a device of
MDT 2007 regarding the production of substances which, if used separately, can be considered to be a
pharmaceuticals medicinal product

Devices manufactured in clean

MDT 2008 rooms and associated controlled • Manufacturing of sterile or clean devices
environments

Devices manufactured using

MDT 2009 processing of materials of human, • Tissue engineering from tissues of human/animal origin (bone…)
animal, or microbial origin

Devices manufactured using

MDT 2010 electronic components including • Manufacturing of active devices
communication devices

Devices which require packaging,

MDT 2011 including labelling • Packaging, labelling

Devices which require installation,

MDT 2012 refurbishment • Installation of biomedical equipment

Devices which have undergone • Manufacturing of surgical devices (Pliers, loops, scalpels,
MDT 2013 reprocessing trocars…), endoscope

GUIDANCE FOR USE BY GMED CUSTOMERS ONLY

GMED property document - RDM 0701-89a rev 0 - 11/03/2020

15
 H EADQUARTER FRENCH REGIONAL OFFICE NORTH AMERICAN SUBSIDIARY
GMED SAS GMED SAS GMED NORTH AMERICA, INC
1 rue Gaston Boissier 19 D rue de la Télématique 6550 Rock Spring Drive - Suite # 280
75015 PARIS • FRANCE 42000 SAINT-ETIENNE • FRANCE BETHESDA, MD 20817 • USA
+33 (0)1 40 43 37 00 +33 (0)4 77 10 11 11 +1 (301) 495 0477
[email protected] [email protected]
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