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KI-WQS
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Tabelle2

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-Rule number,Ruletitle,General explanation,Class,Rule,Examples,Practical Issues of classification
-Rule 1,Devices that either do not come in direct contact with the patient or contact intact skin only,"This is a fall-back rule applying to all devices that are not covered by a more specific rule.
-This is a rule that applies in general to devices that come into contact only with intact skin or that do not come in direct contact with the patient.",I (Klasse 1),"All non-invasive devices are classified as class I, unless one of the rules set out
-hereinafter applies","- Devices intended in general for external patient support
-(e.g. hospital beds, patient hoists, walking aids,
-wheelchairs, stretchers, dental patient chairs)
-- Body liquid collection devices intended to be used in such a
-way that a return flow is unlikely (e.g. to collect body
-wastes such as urine collection bottles, incontinence pads
-or collectors used with wound drainage devices). They may
-be connected to the patient by means of catheters and
-Tubing
-- Devices used to immobilise body parts and/or to apply force
-or compression on them (e.g. non-sterile dressings used to
-aid the healing of a sprain, plaster of Paris, cervical collars,
-gravity traction devices, compression hosiery)
-- Corrective spectacle frames (i.e. glasses) and lenses in
-Frames
-- Stethoscopes
-- Eye occlusion plasters
-- Incision drapes
-- Non-invasive conductive gels i.e. ultrasound gels2
-- Non-invasive electrodes (electrodes for EEG or ECG)
-- Permanent magnets for removal of ocular debris
-- Wheelchairs pushed by hand","Some non-invasive devices are indirectly in contact with the body and can influence internal physiological processes by storing, channelling or
-treating blood, other body liquids or liquids which are returned or infused into the body or by generating energy that is delivered to the body.
-These are handled by other rules because of the hazards inherent in such indirect influence on the body.
-Note 1: Intact skin includes the skin around an established stoma unless the skin is breached. Signs of breached skin include, but not limited
-to, tears, erythema, oedema, weeping and infection. The definition of intact skin must apply for the continuous use of the device.
-Note 2: Ultrasound gels are not to be absorbed or locally dispersed within the body at the site of action in order to achieve their intended
-Purpose."
-,,,,,,
-Rule 2,Channelling or storing for eventual administration,"This rule applies to non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues, liquids or gases for specific
-purposes. Invasive devices, other than surgically invasive devices which are intended to administer medicinal products by inhalation, fall under
-the Rule 20
-These types of devices should be considered separately from the non-contact devices of Rule 1 because they may be indirectly invasive. They
-channel or store substances that will eventually be administered to the body. Typically these devices are used in transfusion, infusion,
-extracorporeal circulation and delivery of anaesthetic gases and oxygen.
-In some cases devices covered under this rule are very simple delivery devices that rely on gravity.",IIa (Klasse 2a),"All non-invasive devices intended for channeling or storing blood, body liquids, cells or tissues,
-liquids or gases for the purpose of eventual infusion, administration or introduction into the
-body are classified as class IIa:
-- if they may be connected to a class IIa, class IIb or class III active device; or if they are
-intended for use for channeling or storing blood or other body liquids or for storing organs,
-parts of organs or body cells and tissues,","- Devices intended to be used as channels in
-active drug delivery systems, e.g. tubing
-intended for use with an infusion pump
-- Devices used for channelling gases, e.g.
-antistatic tubing for anaesthesia, anaesthesia
-breathing circuits
-- Syringes for infusion pumps
-- Devices intended to channel blood (e.g. in
-transfusion, extracorporeal circulation)
-- Devices intended for temporary storage and
-transport of organs for transplantation (i.e.
-containers, bags)
-- Devices intended for long term storage of
-biological substances and tissues such as
-corneas, sperm, human embryos, etc. (i.e.
-containers, bags)
-- Fridges/freezers specifically intended for storing
-blood, tissues etc.
-- Tubings/blood lines for extracorporeal
-treatment (dialysis and apheresis therapies)","If a device, e.g. tubing, intended to be used for a purpose that would require it to be connected to an active device, such a device will be
-automatically in class IIa, unless the manufacturer clearly states that it should not be connected to an active device of class IIa or higher.
-Note 1: ‘May be connected to an active device’ - such a connection is deemed to exist between a non-active device and an active device where
-the non-active device forms a link in the transfer of the substance between the patient and the active device and the safety and performance
-of one of the devices is influenced by the other device. For instance, this applies to tubing in an extracorporeal circulation system which is
-downstream from a blood pump and in the same blood flow circuit, but not directly connected to the pump.
-Note 2: See also Chapter 3.1.6 regarding the possible measuring function."
-Rule 2,,,IIb (Klasse 2b),- except for blood bags; blood bags are classified as class IIb.,"- Blood bags without a substance which, if used
-separately, can be considered to be a medicinal
-product",
-Rule 2,,,I (Klasse 1),"In all other cases, such devices are classified as class I","- Non-invasive devices that provide a simple
-channelling function, with gravity providing the
-force to transport the liquid, e.g. administration
-sets for infusion
-- Devices intended to be used for a temporary
-containment or storage function, e.g. cups and
-spoons specifically intended for administering
-medicines2 Empty syringes without needles",
-,,,,,,
-Rule 3,"Devices that modify biological or chemical composition of human tissues or cells, blood, other body
-liquids or other liquids intended for implantation or administration into the body","These types of devices must be considered separately from the non-contact devices of Rule 1 because they are indirectly invasive. They modify
-substances that will eventually be administered into the body. This rule covers mostly the more sophisticated elements of extracorporeal
-circulation sets, dialysis systems and autotransfusion systems as well as devices for extracorporeal treatment of body fluids which may or may
-not be immediately reintroduced into the body, including cases where the patient is not in a closed loop with the device.
-This rule covers also substances in direct contact with human cells, tissues or organs in vitro before their implantation or administration, without
-substances derived from human or animal origin such as human albumin.",IIb  (Klasse 2b),"All non-invasive devices intended for modifying the biological or chemical composition of human
-tissues or cells, blood, other body liquids or other liquids intended for implantation or
-administration into the body are classified as class IIb,","- Devices intended to remove undesirable
-substances out of the blood by exchange of
-solutes such as hemodialysers
-- Devices intended to separate cells by physical
-means, e.g. gradient medium for sperm
-separation
-- Haemodialysis concentrates
-- Device removing specific blood cells (e.g.
-activated) by specific binding to a matrix","These devices are normally used in conjunction with an active medical device covered under Rule 9 or Rule 11.
-Filtration and centrifugation should be understood in the context of this rule as being done exclusively through mechanical methods"
-Rule 3,,,IIa (Klasse 2a),"unless the treatment for which the device is used consists of filtration, centrifugation or
-exchanges of gas, heat, in which case they are classified as class IIa","- Particulate filtration of blood in an
-extracorporeal circulation system. These are
-used to remove particles from the blood
-- Centrifugation of blood to prepare it for
-transfusion or autotransfusion excluding
-centrifuges for manufacturing a medicinal
-product
-- Removal of carbon dioxide from the blood
-and/or adding oxygen
-- Warming or cooling the blood in an
-extracorporeal circulation system.",
-Rule 3,,,III (Klasse 3),"All non-invasive devices consisting of a substance or a mixture of substances intended to be
-used in vitro in direct contact with human cells, tissues or organs taken from the human body
-or used in vitro with human embryos before their implantation or administration into the body
-are classified as class III.","- Substances or mixture of substances for
-transport, perfusion, storage of organs intended
-for transplantation that do not achieve the
-principal intended action by pharmacological,
-immunological or metabolic means
-- IVF or ART products without principal
-pharmacological/metabolic action (substances
-or mixture of substances)
-- IVF cell media without human albumin",
-,,,,,,
-Rule 4,Devices that come into contact with injured skin or mucous membrane,"This rule applies to non-invasive devices as well as invasive devices that come into contact with injured skin or mucous membrane.
-This rule is intended to primarily cover wound dressings independently of the depth of the skin wound or mucosa wound. The conventional
-types of products, such as those used as a mechanical barrier, are well understood and do not result in any great hazard. There have also been
-rapid technological developments in this area, with the emergence of new types of wound dressings for which new types of claims are made,
-e.g. management of the microenvironment of a wound to enhance its natural healing mechanism.
-More novel claims relate to the mechanism of healing by secondary intent, such as influencing the underlying mechanisms of granulation or
-epithelial formation or preventing contraction of the wound. Some devices used on breached dermis or breached mucosa may even have a life-
-sustaining or lifesaving purpose, e.g. when there is full thickness destruction of the skin or mucosa over a large area and/or systemic impact.
-Dressings incorporating a substance which, if used separately, can be considered to be a medicinal product and that has an action ancillary to
-that of the dressing, fall within class III under Rule 14. Devices composed of other substances which are absorbed by or locally dispersed in the
-human body fall under Rule 21.",I (Klasse 1),"All non-invasive devices which come into contact with injured skin or mucous membrane are
-classified as:
-- class I if they are intended to be used as a mechanical barrier, for compression or for
-absorption of exudates;","- Wound dressings for skin or mucous, such as:
-absorbent pads, island dressings, cotton wool,
-wound strips, adhesive bandages (sticking
-plasters, band-aid) and gauze dressings which
-act as a barrier, maintain wound position or
-absorb exudates from the wound
-- Ostomy bags","The classification of devices covered by this rule depends on the use intended by the manufacturer’s, e.g. a polymeric film dressing would be
-in class IIa if the intended use is to manage the micro-environment of the wound or in class I if its intended use is limited to retaining an
-invasive cannula at the wound site. Consequently, it is impossible to say a priori that a particular type of dressing belongs to a given class
-without knowing its intended use as defined by the manufacturer. However, a claim that the device is interactive or active with respect to the
-wound healing process usually implies that the device is at least class IIa.
-Most dressings that are intended for a use that falls under class IIa or IIb also perform functions that are in class I, e.g. that of a mechanical
-barrier. Such devices are nevertheless classified according to their intended use in the higher class.
-For such devices incorporating a substance which, if used separately, can be considered to be medicinal product or a human blood derivative,
-or animal tissues or derivatives rendered non-viable, see Rule 14 or Rule 18 respectively."
-Rule 4,,,IIb  (Klasse 2b),"- class IIb if they are intended to be used principally for injuries to skin which have breached
-the dermis or mucous membrane and can only heal by secondary intent;","Are principally intended to be used with severe
-Wounds:
-- Dressings intended for ulcerated wounds having
-breached the dermis
-- Dressings intended for burns having breached
-the dermis
-- Dressings for severe decubitus wounds
-- Dressings incorporating means of augmenting
-tissue and providing a temporary skin substitute",
-Rule 4,,,IIa (Klasse 2a),"- class IIa if they are principally intended to manage the micro-environment of injured skin or
-mucous membrane; and","- Hydrogel dressings for wounds or injuries that
-have not breached the dermis or can only heal by
-secondary intent
-- Non-medicated impregnated gauze dressings
-- Polymer film dressings",
-Rule 4,,,IIa (Klasse 2a), - class IIa in all other cases,,
-Rule 4,,,!,"This rule applies also to the invasive devices that come into contact with injured mucous
-Membrane.","- Dressings for nose bleeds (the purpose of the
-dressing is not to manage micro-environment)
-are in class I according to this rule
-- Dental wound dressings not containing animal
-derived material",
-,,,,,,
-Rule 5,Devices invasive with respect to body orifices,"Invasiveness with respect to body orifices must be considered separately from invasiveness that penetrates through a cut in the body surface
-(surgical invasiveness). For short term use, a further distinction must be made between invasiveness with respect to the less vulnerable anterior
-parts of the ear, mouth and nose and the other anatomical sites that can be accessed through natural body orifices. A surgically created stoma,
-which, for example, allows the evacuation of urine or faeces, is also to be considered a body orifice.
-The devices covered by this rule tend to be diagnostic and therapeutic instruments used in particular specialties (otorhinolaryngology,
-ophthalmology, dentistry, proctology, urology and gynaecology).",I (Klasse 1),"All invasive devices with respect to body orifices, other than surgically invasive devices,
-which are not intended for connection to an active device or which are intended for
-connection to a class I active device are classified as:
-class I if they are intended for transient use;","- Handheld mirrors used in dentistry to aid in dental
-diagnosis and surgery
-- Dental impression materials
-- Stomach tubes
-- Impression trays
-- Examination gloves
-- Urinary catheters intended for transient use
-- Embryo transfer catheter and insemination catheter","Regarding devices intended for connection to an active device: the strictest rule and sub-rule resulting in higher classification will apply. For
-instance a trachea cannula for long-term use need to be classified as class IIb.
-Devices composed of substances which are absorbed by or locally dispersed in the human body may also fall under Rule 21"
-Rule 5,,,IIa (Klasse 2a),"- class IIa if they are intended for short-term use, ","- Short term corrective contact lenses
-- Tracheal tubes
-- Indwelling urinary catheters intended for short term
-use
-- Gasses used for insufflation in the body
-- Nasobilliary tubes",
-Rule 5,,,I (Klasse 1),"- except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the
-ear drum or in the nasal cavity, in which case they are classified as class I; and","- Materials for dental impressions
-- Plastic syringe used to measure a quantity of
-medicinal product before oral administration to the
-patient
-- Removable or fixed dental prostheses",
-Rule 5,,,IIb (Klasse 2b),- class IIb if they are intended for long-term use.,"- Urethral stents
-- Long term corrective contact lenses
-- Tracheal cannulae for tracheostoma for long term use
-- Urinary catheters intended for long term use",
-Rule 5,,,IIa (Klasse 2a),"- except if they are used in the oral cavity as far as the pharynx, in an ear canal up to the
-ear drum or in the nasal cavity and are not liable to be absorbed by the mucous membrane,
-in which case they are classified as class IIa.","- Orthodontic wires
-- Fixed dental prostheses
-- Fissure sealants",
-Rule 5,,,IIa (Klasse 2a),"All invasive devices with respect to body orifices, other than surgically invasive devices,
-intended for connection to a class IIa, class IIb or class III active device, are classified as
-class IIa","- Tracheostomy or tracheal tubes connected to a
-ventilator
-- Blood oxygen analysers placed under the eye-lid
-- Powered nasal irrigators
-- Fibre optics in endoscopes connected to surgical lasers
-- Suction catheters or tubes for stomach drainage
-- Dental aspirator tips
-- Endoscopes using a light source in the visible
-spectrum",
-,,,,,,
-Rule 6,Surgically invasive devices intended for transient use (<60 min,"This rule primarily covers three major groups of devices: devices that are used to create a conduit through the skin (e.g. needles, cannulae),
-surgical instruments (e.g. scalpels, saws) and various types of catheters, suckers, etc.",IIa (Klasse 2a),"All surgically invasive devices intended for transient use are classified as class IIa
-unless they:","- Needles used for suturing
-- Needles or syringes
-- Lancets
-- Single use scalpels and single use scalpel
-blades
-- Surgical swabs
-- Surgical gloves
-- Swabs to sample exudates
-- Guidewires or catheters used outside the
-central circulatory system","Note 1: Terms such as ‘surgically invasive device’, ‘central circulatory system’, ‘central nervous system’ and ‘reusable surgical instruments’ are
-defined in Section 2 of Annex VIII to the MDR. In particular surgical instruments connected to an active device are not considered to be ‘reusable
-surgical instruments’.
-Note 2: The expression ‘correct a defect’ does not cover auxiliary devices that are used in heart surgery procedures, e.g. clamps, aortic punch
-instruments. The first indent of this rule does not apply to aortic punches and similar cutting instruments which perform a function similar to
-that of a scalpel.
-Note 3: ‘Dedicated’ means that the intended purpose of the device or accessory is to specifically control, diagnose, monitor or correct a defect
-of the heart or of the central circulatory system.
-Note 4: The concept of ‘potentially hazardous manner’ is related to the characteristics of the device and not to the competence of the user."
-Rule 6,,,III (Klasse 3),"- are intended specifically to control, diagnose, monitor or correct a defect2 of the heart or of
-the central circulatory system through direct contact with those parts of the body, in which
-case they are classified as class III;","- Cardiovascular catheters (e.g. angioplasty
-balloon catheters, stent delivery
-catheters/systems), including related guidewires, related introducers and
-dedicated disposable cardiovascular surgical
-instruments e.g. electrophysiological
-catheters, electrodes for electrophysiological
-diagnosis and ablation,
-- Catheters containing or incorporating sealed
-radioisotopes, where the radioactive isotope is
-not intended to be released into the body, if
-used in the central circulatory system
-- Distal protection devices",
-Rule 6,,,I (Klasse 1),"- are reusable surgical instruments, in which case they are classified as class I; ","- Scalpels and scalpel handles
-- Reamers
-- Drill bits
-- Saws, that are not intended for connection to
-an active device
-- Retractors forceps, excavators and chisels
-- Sternum retractors for transient use
-- Staplers (outside the heart, central circulatory
-or central nervous system
-- Dental Osteotomes",
-Rule 6,,,III (Klasse 3),"- are intended specifically for use in direct contact with the heart or central circulatory system
-or the central nervous system, in which case they are classified as class III","- Neuro-endoscopes
-- Brain spatulas
-- Direct stimulation cannulae
-- Spinal cord retractors
-- Spinal needles
-- Cranium guide for use in craniotomy
-- Dura mater protection; Bone punch for use on
-the cranium (Intended use: The dura mater
-protection is intended to protect the dura
-mater during surgical procedures. It has direct
-contact to the CNS. The bone punch can be
-used at the cranium. A direct contact to the
-CNS is possible during application.)
-- Peripherally inserted central catheter (PICC)
-line
-- Heart valve occluders, sizers and holders
-- Cardiovascular drainage cannula specifically
-intended to circulate blood whilst located in
-the heart or central vascular system
-- Cryo-ablation of the heart or spine
-- Appliers/Forceps for aneurysm clips",
-Rule 6,,,IIb (Klasse 2b),"- are intended to supply energy in the form of ionising radiation in which case they are classified
-as class IIb;
-- or","- Catheters containing or incorporating sealed
-radioisotopes, where the radioactive isotope
-as such is not intended to be released into the
-body, excluding the central circulatory system",
-Rule 6,,,IIb (Klasse 2b),"- have a biological effect or are wholly or mainly absorbed in which case they are classified as
-class IIb;",- Viscoelastic solution for ophthalmic surgery,
-Rule 6,,,IIb (Klasse 2b),"- are intended to administer medicinal products by means of a delivery system, if such
-administration of a medicinal product is done in a manner that is potentially hazardous taking
-account of the mode of application, in which case they are classified as class IIb.","- Refillable insulin pens
-- Analgesia pumps",
-,,,,,,
-Rule 7,Surgically invasive devices intended for short-term use (> 60 min <30 days),"These are mostly devices used in the context of surgery or post-operative care (e.g. clamps, drains), infusion devices (e.g. cannulae, needles)
-and catheters of various types.",IIa (Klasse 2a),"All surgically invasive devices intended for short-term use are classified as class IIa
-unless they:","- Clamps
-- Infusion cannulae
-- Skin closure devices
-- Temporary filling materials
-- Arthroscopy trocars
-- Insufflation gases for surgically invasive
-endoscopic procedures","Note 1: Administration of medicinal products is more than just channelling, it implies also storage and/or control of the volume and rate of
-delivery. Implanted capsules for the slow release of medicines, placed on the market as a single integral product, are governed by Directive
-2001/83/EC or Regulation (EC) No 726/2004."
-Rule 7,,,III (Klasse 3),"are intended specifically to control, diagnose, monitor or correct a defect of the heart or of
-the central circulatory system through direct contact with those parts of the body, in which
-case they are classified as class III;","- Cardiovascular catheters
-- Cardiac output probes
-- Temporary pacemaker leads
-- Thoracic catheters intended to drain the heart,
-including the pericardium
-- Carotid artery shunts
-- Ablation catheter
-- Heart bypass cannula (aortic perfusion cannula
-and venous drainage cannula)
-- Peripherally inserted central catheter (PICC) line
-and central line",
-Rule 7,,,III (Klasse 3),"are intended specifically for use in direct contact with the heart or central circulatory system
-or the central nervous system, in which case they are classified as class III;","- Neurological catheters
-- Cortical electrodes
-- Central venous/vascular catheters",
-Rule 7,,,IIb (Klasse 2b),"are intended to supply energy in the form of ionizing radiation in which case they are
-classified as class IIb;",- Brachytherapy devices,
-Rule 7,,,III (Klasse 3),"have a biological effect or are wholly or mainly absorbed in which case they are classified as
-class III;",- Absorbable sutures,
-Rule 7,,,IIb (Klasse 2b),"are intended to undergo chemical change in the body in which case they are classified as
-class IIb, except if the devices are placed in the teeth; or.","- Vascular closure devices
-- Haemostatic foams",
-Rule 7,,,IIb (Klasse 2b),"are intended to administer medicines1, in which case they are classified as class IIb.","- Temporal dialysis catheter, CVVH catheter",
-,,,,,,
-Rule 8,Implantable devices and long-term surgically invasive devices (> 30 days,"These are mostly implants in the orthopaedic, dental, ophthalmic and cardiovascular fields as well as soft tissue implants such as implants used
-in plastic surgery.",IIb (Klasse 2b),"All implantable devices and long-term surgically invasive devices are classified as class IIb
-unless they:","- Artificial ligaments for reinforcement2. Dental
-implants and abutments
-- Shunts
-- Peripheral stents and peripheral valves
-- Plates
-- Intra-ocular lenses
-- Internal closure devices (including vascular
-closure devices1)
-- Tissue augmentation implants (excluding
-breasts)
-- Peripheral vascular catheters for long-term use
-- Peripheral vascular grafts and stents
-- Penile implants
-- Non-absorbable sutures, non-biodegreable bone
-cements and maxillo-facial implants, visco-
-elastic surgical devices intended specifically for
-ophthalmic anterior segment surgery2
-- Pedicle screws","Note 1: For closure of arteriotomies in the peripheral vascular system (refer to definition of central circulatory system).
-Note 2: These devices are implants because in normal conditions a significant amount of the substance remains at the surgical site after the
-procedure. Rule 18 may also be relevant.
-Note 3: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class IIb
-following the general rule.
-Note 4: The clause about chemical change under this rule does not apply to products such as bone cements where the chemical change takes
-place during the placement and does not continue in long term.
-Note 5: Also non-implantable and non-active accessories to AIMDs should be classified as Class III under Rule 8."
-Rule 8,,,IIa (Klasse 2a),"- are intended to be placed in the teeth3, in which case they are classified as class IIa;","- Bridges and crowns
-- Dental filling materials and pins
-- Dental alloys, ceramics and polymers",
-Rule 8,,,III (Klasse 3),"- are intended to be used in direct contact with the heart, the central circulatory system or
-the central nervous system, in which case they are classified as class III;","- Prosthetic heart valves
-- Aneurysm clips
-- Vascular prosthesis and stents
-- Central vascular catheters for long-term use
-- Spinal stents
-- CNS electrodes
-- Cardiovascular sutures
-- Permanent and retrievable vena cava filters
-- Septal occlusion devices
-- Intra-aortic balloon pumps
-- External left ventricular assisting devices",
-Rule 8,,,III (Klasse 3),"- have a biological effect or are wholly or mainly absorbed, in which case they are classified
-as class III;","- Long term absorbable sutures
-- Adhesives and implantable devices claimed to be
-bioactive through the attachment of surface
-coatings such as phosphoryl choline
-- Biodegrable Bone Cements
-- Elastoviscus fluids for joint movement(eg.
-hyaluronan of non-animal origin)",
-Rule 8,,,III (Klasse 3),"- are intended to undergo chemical change4 in the body in which case they are classified as
-class III, except if the devices are placed in the teeth",,
-Rule 8,,,III (Klasse 3),"-  are intended to administer medicinal products, in which case they are classified as class III;","- Rechargeable non-active drug delivery systems
-- Peritoneal dialysis",
-Rule 8,,,III (Klasse 3),"- are active implantable devices or their accessories, in which cases they are classified as
-class III;","- Cochlear implants and accessories
- Implantable cardiac pacemakers
-- Implantable cardioverter defibrillators (ICD)
-- Leads, electrodes, adaptors for pacemakers and
-implantable defibrillators
-- Implantable nerve stimulators
-- Implantable bladder stimulators
-- Implantable sphincter stimulators
-- Accessories to active implantable devices (with
-or without contact to the heart), be it
-implantable or non-implantable active or not5:
--- torque wrench for implantable pulse
-generator / implantable cardioverter
-defibrillator
--- cables for programmer / pacing system
-analyser
--- magnet for Implantable Pulse Generator /
-Implantable Cardioverter Generator
--- programmer or an external transmitter
-intended for activating or controlling the
-implantable part of the device
--- implantable pacemaker leads",
-Rule 8,,,III (Klasse 3),"- are breast implants or surgical meshes, in which cases they are classified as class III;","- Breast implants
-- Breast tissue expanders
-- Surgical meshes for hernia repair
-- Tension free vaginal tape",
-Rule 8,,,III (Klasse 3),"- are total or partial joint replacements, in which case they are classified as class III, with
-the exception of ancillary components such as screws, wedges, plates and instruments;
-or","- Hip, knee
-- Shoulder
-- Ankle",
-Rule 8,,,III (Klasse 3),"- are spinal disc replacement implants or are implantable devices that come into contact with
-the spinal column, in which case they are classified as class III with the exception of
-components such as screws, wedges, plates and instruments","- Spinal disc replacement implants
-- Spinal implants: hooks that fix the rod on the
-spinal column
-- Stems that are implantable in contact with the
-spinal column
-- Device placed in the disc space
-- Interbody fusion devices",
-,,,,,,
-Rule 9,"Active therapeutic devices intended to administer or exchange energy, as well as active devices
-intended to control/monitor/directly influence certain devices","This rule covers many different groups of devices, such as:
-- electrical equipment used in surgery such as lasers and surgical generators;
-- stimulation devices;
-- devices intended to emit ionizing radiation2 for therapeutic purposes, including devices which control or monitor such devices, or which
-directly influence their performance;
-- devices intended for controlling, monitoring or directly influencing the performance of active implantable devices.
-Active implantable devices are covered by Rule 8.
-Rule 22 may also apply to active therapeutic devices.",IIa (Klasse 2a),"All active therapeutic devices intended to administer or exchange energy are classified as
-class IIa","- Electrical and/or magnetic and electromagnetic
-Energy:
--- muscle stimulators
--- external bone growth stimulators
--- TENS devices
--- eye electromagnets
--- electrical acupuncture
-- Thermal energy:
---heat exchangers, except the types described
-below
-- Mechanical energy:
---powered dermatomes
---powered drills
---dental hand pieces
-- Light:
---phototherapy for skin treatment and for
-neonatal care
-- Sound:
---external hearing aids
-- Ultrasound:
---equipment for physiotherapy
-- Sleep apnoea ventilators without monitoring
-function","Note 1: The decision as to whether a medical device administers or exchanges energy to and from the human body in a potentially hazardous
-way should take into account the following factors. The concept of ‘potentially hazardous’ is dependent on the type of technology involved and
-the intended application of the device to the patient and not on the measures adopted by the manufacturer in view of good design management
-(e.g. use of technical standards, risk analysis). For instance, all devices intended to emit ionizing radiation, all lung ventilators and lithotriptors
-should be in Class IIb. However, the manufacturer's obligation to comply with design requirements and solutions adopted, exist independently
-from the classification system. Devices for illumination, i.e. administration of rays in visible light spectrum, for use in the process of diagnosis
-are classified as class IIa or higher, e.g. visual electrophysiology or fundoscopes for examination of the eye; whereas devices for illumination
-for purposes other than in the process of diagnosis, e.g. therapeutic purposes (light therapy), are class I.
-Note 2: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometres or
-less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46)."
-Rule 9,,,IIb (Klasse 2b),"unless their characteristics are such that they may administer energy to or exchange energy
-with the human body in a potentially hazardous way, taking account of the nature, the
-density and site of application of the energy, in which case they are classified as class Iib.","- Kinetic energy:
- lung ventilators
-- Thermal energy:
---incubators for babies
---blood warmers
---electrically powered heat exchangers (with
-patients incapable of reacting,
-communicating /or who are without a sense
-of feeling)
-- Electrical energy:
--- high-frequency electrosurgical generators,
-and electrocautery equipment, including their
-electrodes
--- external pacemakers and external
-defibrillators with no integrated or
-incorporated diagnostic function
--- electroconvulsive therapy equipment
-- Coherent light: surgical lasers
--Ultrasound: lithotriptors, surgical ultrasound devices, high-intensity focused ultrasound (HIFU",
-Rule 9,,,IIb (Klasse 2b),"All active devices intended to control or monitor the performance of active therapeutic class
-IIb devices, or intended directly to influence the performance of such devices are classified
-as class Iib.","- External feedback systems for active therapeutic
-devices",
-Rule 9,,,IIb (Klasse 2b),"All active devices intended to emit ionizing radiation for therapeutic purposes, including
-devices which control or monitor such devices, or which directly influence their performance,
-are classified as class Iib","- Brachytherapy therapy devices if the device also
-generates the radiation
-- Therapeutic cyclotrons and linear accelerators
-- Therapeutic X-ray sources",
-Rule 9,,,III (Klasse 3),"All active devices that are intended for controlling, monitoring or directly influencing the
-performance of active implantable devices are classified as class III","- Programming units and pacing system analysers
-- Cardioscopes with pacing pulse indicators
-specifically intended to monitor active implantable
-devices
-- Programmer for:
--- implantable Pulse Generator (IPG);
--- implantable Cardioverter Defibrillator (ICD)
--- implantable Loop Recorder
-- Remote monitoring devices for active implantable
-devices",
-,,,,,,
-Rule 10,Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology,"This rule covers a whole range equipment in various fields for capture of physiological signals, as well as specifically therapeutic and diagnostic
-radiology. Note that devices for recording diagnostic X-ray images are covered by Rule 17. Devices specifically intended to monitor active
-implantable devices fall under Rule 8 or Rule 9.",IIa (Klasse 2a),"Active devices intended for diagnosis and monitoring are classified as class IIa:
-- if they are intended to supply energy which will be absorbed by the human body,","- Magnetic resonance equipment
-- Pulp testers
-- Evoked response stimulators
-- Diagnostic ultrasound","Note 1: ‘Illuminate’ means: to administer rays in visible light spectrum to for use in the process of diagnosis for example in visual
-electrophysiology and eye diseases, and not just to cast a light to improve the visibility. When performing diagnosis to, for example, perform
-visual electrophysiology in search of eye diseases, the intended purpose of the device is not limited to ‘illumination’, but may include diagnosis.
-Note 2: A device is considered to allow direct diagnosis when it itself provides the diagnosis of the disease or condition in question or when it
-provides decisive information for the diagnosis (MDR 2017/745, Annex VIII, 3.7). For the definition of diagnosis see the MDCG Guidance
-document covering the borderline between medical devices and medicinal products.
-Note 3: Vital physiological processes and parameters include, for example, respiration, heart rate, cerebral functions, blood gases, blood
-pressure and body temperature. Medical devices intended to be used for continuous surveillance of vital physiological parameters in anesthesia,
-intensive care or emergency care are in class IIb, whilst medical devices intended to be used to obtain readings of vital physiological signals as
-part of routine checkups or self-monitoring are in class IIa. A thermal imaging device intended to monitor blood flow is not considered to be a
-body temperature measuring device.
-Note 4: ‘Ionising radiation’ means energy transferred in the form of particles or electromagnetic waves of a wavelength of 100 nanometers or
-less (a frequency of 3 × 1015 hertz or more) capable of producing ions directly or indirectly (Directive 2013/59/EURATOM, Article 4, 46).
-Note 5: Therapeutic interventional radiology refers to diagnosis being carried out during a surgical procedure.
-Note 6: This refers to active devices for the control, monitoring or influencing the emission of ionizing radiation and not to the subsequent
-processing, recording or viewing of the resulting image. Devices for recording diagnostic X-ray images are covered by Rule 17."
-,,,I (Klasse 1),"except for devices intended to illuminate1 the patient's body, in the visible spectrum, in which
-case they are classified as class I;","- Examination lamps
-- Surgical microscopes intended to illuminate the
-patient’s body in the visible spectrum
-- Dermatoscopes with integrated light sources",
-,,,IIa (Klasse 2a),- if they are intended to image in vivo distribution of radiopharmaceuticals; or,"- Gamma cameras
-- Positron emission tomography and single
-photon emission computer tomography",
-,,,IIa (Klasse 2a),- if they are intended to allow direct diagnosis2 or monitoring of vital physiological processes,"- Electrocardiographs
-- Electroencephalographs
-- Electronic thermometers
-- Electronic stethoscopes
-- Electronic blood pressure measuring equipment",
-,,,IIb (Klasse 2b),"unless they are specifically intended for monitoring of vital physiological parameters and the
-nature of variations of those parameters is such that it could result in immediate danger to
-the patient, for instance variations in cardiac performance, respiration, activity of the central
-nervous system, or they are intended for diagnosis in clinical situations where the patient is
-in immediate danger, in which cases they are classified as class IIb.","- Blood gas analysers used in open heart surgery
-- Apnoea monitors, including apnoea monitors in
-home care
-- Patient monitors (intended use: Monitor
-intended for multi-parameter patient
-monitoring. The device will produce visual and
-audible alarms if any of the physiological
-parameters monitored vary beyond pre-set
-limits and timed alarm recordings will be
-produced.), for example in intensive care
-monitoring, e.g. blood pressure, temperature,
-oxygen saturation",
-,,,IIb (Klasse 2b),"Active devices intended to emit ionizing radiation4 and intended for diagnostic or
-therapeutic radiology, including interventional radiology devices and devices which
-control or monitor such devices, or which directly influence their performance, are
-classified as class IIb.","- Diagnostic X-Ray machine
-- Computed Tomography Devices",
-,,,,,,
-Rule 11,,,IIa (Klasse 2a),"Software intended to provide information which is used to take decisions with diagnosis or
-therapeutic purposes is classified as class IIa,
-except if such decisions have an impact that may cause:","- MDSW intended to rank therapeutic suggestions
-for a health care professional based on patient
-history, imaging test results, and patient
-characteristics, for example, MDSW that lists
-and ranks all available chemotherapy options for
-BRCA-positive individuals.
-- Cognitive therapy MDSW where a specialist
-determines the necessary cognitive therapy
-based on the outcome provided by the MDSW.",
-,,,III (Klasse 3),"— death or an irreversible deterioration of a person's state of health1, in which case it is in
-class III; or","- MDSW intended to perform diagnosis by means
-of image analysis for making treatment
-decisions in patients with acute stroke.",
-,,,IIb (Klasse 2b),"— a serious deterioration of a person's state of health1 or a surgical intervention, in which case
-it is classified as class Iib.","- A mobile app intended to analyse a user’s
-heartbeat, detect abnormalities and inform a
-physician accordingly.
-MDSW intended for diagnosing depression based
-on a score resulting from inputted data on
-patient symptoms (e.g. anxiety, sleep patterns,
-stress etc.).",
-,,,IIa (Klasse 2a),"Software intended to monitor physiological processes is classified as class Iia,","- MDSW intended to monitor physiological
-processes that are not considered to be vital.
-- Devices intended to be used to obtain readings
-of vital physiological signals in routine check-ups
-including monitoring at home.",
-,,,IIb (Klasse 2b),"except if it is intended for monitoring of vital physiological parameters3, where the nature of
-variations of those parameters is such that it could result in immediate danger to the patient,
-in which case it is classified as class Iib.","- Medical devices including MDSW intended to be
-used for continuous surveillance of vital
-physiological processes in anaesthesia, intensive
-care or emergency care.",
-,,,I (Klasse 1),All other software is classified as class I. ,"- MDSW app intended to support conception by
-calculating the user’s fertility status based on a
-validated statistical algorithm. The user inputs
-health data including basal body temperature (BBT) and menstruation days to track and
-predict ovulation. The fertility status of the
-current day is reflected by one of three indicator
-lights: red (fertile), green (infertile) or yellow
-(learning phase/cycle fluctuation).",
-,,,,,,
-Rule 12,,,IIa (Klasse 2a),"All active devices intended to administer and/or remove medicinal products, body liquids or
-other substances to or from the body are classified as class Iia,","- Suction pump
-- Feeding pumps
-- Jet injectors for vaccination
-- Elastomeric pumps or balloon pumps for infusion",
-Rule 12,,,IIb (Klasse 2b),"unless this is done in a manner that is potentially hazardous, taking account of the nature of
-the substances involved, of the part of the body concerned and of the mode of application in
-which case they are classified as class Iib.","- Infusion pumps
-- Ventilators
-- Anaesthesia machines
-- Anaesthetic vaporisers
-- Dialysis equipment
-- Blood pumps for heart-lung machines
-- Hyperbaric chambers
-- Pressure regulators for medical gases
-- Medical gas mixers
-- Moisture exchangers in breathing circuits if used
-on unconscious or non-spontaneously breathing
-patients
-- Oxygen concentrator used to deliver oxygen
-enriched air directly to the patient",
-,,,,,,
-Rule 13,,,I (Klasse 1),All other active devices are classified as class I. ,"- Electric wheelchairs
-- Dental curing lights
-- Electric hospital beds
-- Patient hoists
-- Dental patient chairs",
-,,,,,,
-Rule 14,,,III (Klasse 3),"All devices incorporating, as an integral part, a substance which, if used separately, can be
-considered to be a medicinal product, as defined in point 2 of Article 1 of Directive
-2001/83/EC, including a medicinal product derived from human blood or human plasma, as
-defined in point 10 of Article 1 of that Directive, and that has an action ancillary to that of the
-devices, are classified as class III.","- Bone cement with antibiotics
-- Condoms with spermicide
-- Catheters coated with anticoagulants (e. g. heparin)
-- Endodontic materials with antibiotics
-- Ophthalmic irrigation solutions principally
-intended for irrigation, which contain
-components supporting the metabolism of the
-endothelial cells of the cornea
-- Dressings incorporating an antimicrobial agent
-where the agent has an ancillary action on the
-wound
-- Drug eluting stents (e.g. coronary, pulmonary)
-- Surgical sealants containing human serum
-albumin or thrombin
-- Implants coated with human fibrinogen
-- Blood bags incorporating heparin or other
-substances as anticoagulant agents which, if
-used separately, can be considered to be a
-medicinal product
-- IVF cell media with human albumin2
-- Intra Uterine Devices (IUD) containing medicinal
-substances3 including copper or silver
-- Catheter lubrication gels containing analgesia
-e.g. lidocaine",
-,,,,,,
-Rule 15,,,IIb (Klasse 2b),"All devices used for contraception or prevention of the transmission of sexually transmitted
-diseases are classified as class Iib,","- Condoms and femidoms (internal condoms)
-- Contraceptive diaphragms
-- Fertility monitors and medical device software
-intended to be used in contraception (e.g. by
-using the basal body temperature)",
-Rule 15,,,III (Klasse 3),"unless they are implantable or long term invasive devices, in which case they are classified as
-class III.","- Tubal ligation devices (e.g. clips or rings)
-- Non-hormonal intrauterine contraceptive
-devices (IUCD or ICD)",
-,,,,,,
-Rule 16,,,IIb (Klasse 2b),"All devices intended specifically to be used for disinfecting, cleaning, rinsing or, where
-appropriate, hydrating contact lenses are classified as class Iib.","- Contact lens storing solutions
-- Cleaners for contact lenses
-- Ultraviolet, vibration, or ultrasonic devices for
-cleaning and disinfecting contact lenses",
-Rule 16,,,IIa (Klasse 2a),"All devices intended specifically to be used for disinfecting or sterilising medical devices are
-classified as class Iia,","- Disinfecting solutions specifically intended for
-non-invasive medical devices
-- Washer-disinfectors intended specifically for
-disinfecting non-invasive medical devices
-- Sterilisers intended to sterilise medical devices in
-a medical environment",
-Rule 16,,,IIb (Klasse 2b),"unless they are disinfecting solutions or washer-disinfectors intended specifically to be used
-for disinfecting invasive devices, as the end point of processing1, in which case they are
-classified as class Iib.","- Solutions/disinfectors for trans oesophageal
-ultrasound probes)
-- Washer-disinfector equipment specifically for
-disinfecting endoscopes or other invasive devices
-at the end point of processing (e. g. dental
-equipment)
-- Disinfectants for the fluid pathways of
-haemodialysis equipment
-- Denture disinfecting products",
-Rule 16,,,!,"This rule does not apply to devices that are intended to clean devices other than contact
-lenses by means of physical action only.","- Brushes specifically intended to clean medical
-devices by mechanical action
-- Ultrasonic devices (for other devices than contact
-lenses)",
-,,,,,,
-Rule 17,,,IIa (Klasse 2a),"Devices specifically intended for recording of diagnostic images generated by X-ray radiation
-are classified as class Iia.","- Digital x-ray detectors for recording images
-- Photostimulable phosphor plates
-- X-ray films",
-,,,,,,
-Rule 18,,,III (Klasse 3),"All devices manufactured utilising tissues or cells of human or animal origin, or their
-derivatives1, which are non- viable or rendered non-viable, are classified as class III,","- Animal derived biological heart valves
-- Porcine xenograft dressings
-- Devices made from animal sourced
-collagen/gelatine
-- Devices utilising hyaluronic acid of animal origin
-- Substance-based devices containing collagen
-for use in body orifices
-- Collagen dermal fillers
-- Bone graft substitutes",
-Rule 18,,,I (Klasse 1),"unless such devices are manufactured utilising tissues or cells of animal origin, or their
-derivatives, which are non-viable or rendered non-viable and are devices intended to come
-into contact with intact skin only.",- Leather components of orthopaedic appliances,
-,,,,,,
-Rule 19,,,,All devices incorporating or consisting of nanomaterial are classified as,,
-Rule 19,,,III (Klasse 3),—class III if they present a high or medium potential for internal exposure,"- Bone fillers with nanomaterials in their formulation (not
-polymerized before blood/tissue contact, and degradable)
-- Superparamagnetic iron oxide nanoparticles
-(Intended use: thermal ablation of tumors or thermal modulation
-of the tumor microenvironment by submission to alternating
-magnetic fields)
-- Intravascular catheter made of non-degradable polymer, with
-nano-coating",
-Rule 19,,,IIb (Klasse 2b),— class IIb if they present a low potential for internal exposure,"- Bone fixation screws/plates with a strongly bound nano-coating
-high potential
-- Solution administration set made of non-degradable polymer,
-with a strongly bound nano-coating",
-Rule 19,,,IIa (Klasse 2a),— class IIa if they present a negligible potential for internal exposure ,"- Intravascular catheter for short term use made of non-
-degradable polymer, with nanomaterial embedded in the polymer
-matrix
-- Solution administration set made of non-degradable polymer,
-with nanomaterial embedded in the polymer matrix
-- Dental filling materials",
-,,,,,,
-Rule 20,,,IIa (Klasse 2a),"All invasive devices with respect to body orifices, other than surgically invasive devices, which
-are intended to administer medicinal products by inhalation are classified as class Iia,","- Spacer intended for metered dose inhalers
-(attached to the inhaler) unless treating life-
-threatening conditions.
-- Inhalers for nicotine replacement therapy
-(nicotine not included)
-- Oxygen delivery system with a nasal cannula
-unless treating life-threatening conditions
-- Inhalers and nebulisers in case their mode of
-action has probably no essential impact on the
-efficacy and safety of the administered
-medicinal product or which are not intended to
-treat life-threatening conditions",
-Rule 20,,,IIb (Klasse 2b),"unless their mode of action has an essential impact1 on the efficacy and safety of the
-administered medicinal product or they are intended to treat life- threatening conditions, in
-which case they are classified as class Iib","- Nebulisers (not pre-charged with a specific
-medicinal product) where the failure to deliver
-the appropriate dosage characteristics could be
-hazardous
-- Spacer intended for metered dose inhalers
-attached to the inhaler",
-,,,,,,
-Rule 21,,,III (Klasse 3),"Devices that are composed of substances or of combinations of substances that are intended to be
-introduced into the human body via a body orifice or applied to the skin and that are absorbed by or
-locally dispersed in the human body are classified as:
-— class III if they, or their products of metabolism, are systemically absorbed by the human body in
-order to achieve the intended purpose;",,
-Rule 21,,,III (Klasse 3),"— class III if they achieve their intended purpose in the stomach or lower gastrointestinal tract and
-they, or their products of metabolism, are systemically absorbed by the human body;","- Na/Mg alginate, xyloglucan
-- Fat absorbers that are systemically
-absorbed, themselves or their metabolites",
-Rule 21,,,IIa (Klasse 2a),"— class IIa if they are applied to the skin or if they are applied in the nasal or oral cavity as far as
-the pharynx1, and achieve their intended purpose on those cavities; and","- Substance-based formulations for skin
-treatment
-- Salt water used e.g. as nose or throat
-sprays
-- Oral cough treatments achieving their
-intended purpose in the oral cavity as far
-as the pharynx",
-Rule 21,,,IIb (Klasse 2b),— class IIb in all other cases.,"- Simethicone preparations for oral
-administration
-- Active coal for oral administration
-- Gel for vaginal moisturizing / vaginal
-lubricants
-- Eye drops for hydration
-- Ear drops1, 2
-- Medical devices, for oral administration,
-for the treatment of diarrhoea, e.g. kaolin,
-diosmectite
-- Medical devices, for oral administration,
-for the treatment of obesity, e.g.
-fructooligosaccharides, glucomannan",
-,,,,,,
-Rule 22,,,III (Klasse 3),"Active therapeutic devices with an integrated or incorporated diagnostic function1 which
-significantly determines the patient management by the device, such as closed loop systems
-or automated external defibrillators, are classified as class III.","- Automated external defibrillators (AED)
-including their pads/electrodes
-- Semiautomatic external defibrillators
-- Automated closed loop insulin delivery system
-- Automated external infusion pumps with
-integrated sensors to adapt the infusion therapy
-- Devices in brain-computer interfaces (BCIs) –
-used for e.g. motor control in severely paralyzed
-patients
-- Closed-loop systems for deep brain stimulation
-(DBS) treatment of various neurological
-Conditions
-- Closed-loop dynamic neurochemical control of
-therapeutic interventions e.g. target-controlled
-anaesthesia / infusion systems",