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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",