Classification

Medical Device Regulation (MDR)

REGULATION (EU) 2017/745, 5 April 2017 on medical devices


MDR Classification

Non-invasive devices
  • Rule 1
  • All non-invasive devices are classified as [Class I] unless one of the rules specified below applies.
  • Rule 2
    • All non-invasive devices intended to channel or store blood, body fluids, cells, or tissues, liquids, or gases for the purpose of eventual infusion, administration, or introduction into the human body are classified as [Class IIa] if:
    • – They can be connected to a [Class IIa, IIb, or III] device; or
    • – They are intended to channel or store blood or other body fluids, or to store organs, parts of organs, or human cells or tissues. (Blood bags are classified as [Class IIb] and are an exception to this classification rule.)
    • In all other cases, such devices are classified as [Class I].
  • Rule 3
    • All non-invasive devices intended to modify the biological or chemical composition of blood, other body fluids, liquids, or substances to be infused or administered into the human body are classified as [Class IIb], unless the device consists of filtration, centrifugation, or gas exchange by heat transfer, in which case it is classified as [Class IIa].
    Non-invasive devices that are composed of substances or a combination of substances intended for direct contact with human cells or tissues, organs extracted from the human body, or for use with human embryos outside the body prior to implantation or introduction into the human body are classified as [Class III].
  • Rule 4
    • All non-invasive devices that come into contact with injured skin or mucous membranes are classified as follows:
    • – [Class I] if they are intended to be used as a mechanical barrier to absorb exudates (fluids or cells that have leaked out of blood vessels due to inflammation).
    • – [Class IIb] if they are primarily intended for use on injured skin where the dermis or mucosa has been breached and healing occurs only by secondary intention.
    • – [Class IIa] if they are intended to manage the microbial environment of injured skin or mucous membranes.
    • – [Class IIa] for all other cases.
    • This rule also applies to invasive devices in contact with injured mucous membranes.

Invasive devices
  • Rule 5
  • All devices introduced through a body orifice, not surgically invasive, and not intended to be connected to an active device or intended to be connected only to a [Class I] active device are classified as follows:
    • – [Class I] if intended for transient use.
    • – [Class IIa] if intended for short-term use, except for devices intended for use within the oral cavity up to the pharynx, external ear canal up to the eardrum, or nasal cavity, which are classified as [Class I].
    • – [Class IIb] if intended for long-term use, except for devices intended for use within the oral cavity up to the pharynx, external ear canal up to the eardrum, or nasal cavity, which are not easily absorbed by the mucous membrane and are classified as [Class IIa].
    • All devices not surgically invasive and introduced through a body orifice intended to be connected to a [Class IIa, IIb, or III] device are classified as [Class IIa].
  • Rule 6
    • All surgically invasive devices intended for transient use are classified as [Class IIa], except in the following cases:
    • – Devices specifically intended to diagnose, monitor, control, or correct a defect of the heart or central circulatory system in direct contact with those parts are classified as [Class III].
    • – Devices intended for short-term use are classified as [Class IIa], except for devices intended for use within the oral cavity up to the pharynx, external ear canal up to the eardrum, or nasal cavity, which are classified as [Class I].
    • – Devices specifically intended to come into direct contact with the heart, central circulatory system, or central nervous system are classified as [Class III].
    • – Devices intended to supply energy in the form of ionizing radiation are classified as [Class IIb].
    • – Devices with biological effects or wholly or partially absorbed are classified as [Class IIb].
    • – Devices intended for drug delivery through a delivery system where the mode of operation poses potential risks are classified as [Class IIb].
    Rule 7
    All surgically invasive devices intended for short-term use are classified as [Class IIa], except in the following cases:
    • – Devices specifically intended to diagnose, monitor, control, or correct a defect of the heart or central circulatory system in direct contact with those parts are classified as [Class III].
    • – Devices specifically intended to come into direct contact with the heart, central circulatory system, or central nervous system are classified as [Class III].
    • – Devices intended to supply energy in the form of ionizing radiation are classified as [Class IIb].
    • – Devices with biological effects or wholly or partially absorbed are classified as [Class III].
    • – Devices intended to induce chemical changes in the body, except those applied to teeth, are classified as [Class IIb].
    • – Devices intended for the administration of drugs are classified as [Class IIb].
  • Rule 8
    • All surgically invasive devices intended for long-term use and implantable devices are classified as [Class IIb], except in the following cases:
    • – Devices intended to be implanted into teeth are classified as [Class IIa]
    • – Devices specifically intended to come into direct contact with the heart, central circulatory system, or central nervous system are classified as [Class III]
    • – Devices with biological effects or wholly or partially absorbed are classified as [Class III]
    • – Devices intended to induce chemical changes in the body, except those applied to teeth, are classified as [Class IIb]
    • – Devices intended for drug administration are classified as [Class IIb]
    • – Active implantable devices or their accessories are classified as [Class III]
    • – Breast implants or surgical meshes are classified as [Class III]
    • – Joint replacements, excluding ancillary components such as screws, wedges, plates, and instruments, are classified as [Class III]
    • – Implantable devices intended for spinal disc replacement or those in contact with the spine, excluding ancillary components such as screws, wedges, plates, and instruments, are classified as [Class III]

Active Devices
  • Rule 9
    • – Active therapeutic devices intended to deliver or exchange energy are classified as [Class IIa]. However, if the mode of delivering or exchanging energy to the human body poses potential risks, considering the type and density of energy used and the area of application, they are classified as [Class IIb].
    • – All active devices intended to control or monitor the performance of [Class IIb] devices, or to directly influence their performance, are classified as [Class IIb]
    • – Devices intended to emit ionizing radiation for therapeutic purposes, or to control, monitor, or directly influence the performance of such devices, are classified as [Class IIb]
    • – Devices intended to control, monitor, or directly influence the performance of active implantable devices are classified as [Class III]
  • Rule 10
    • Active devices for diagnosis or monitoring are classified as [Class IIa]
    • – If the device is intended to deliver energy that will be absorbed by the human body, it is classified as [Class IIa], except for devices intended to illuminate the patient’s body within the visible light spectrum, which are classified as [Class I]
    • – Devices intended to image the distribution of radiopharmaceuticals within the body, or to directly diagnose or monitor vital physiological processes, are classified as [Class IIa]
    • – If the physiological variables being monitored are critical indicators, such as cardiac activity, respiration, or central nervous system activity, where variations could pose an immediate risk to the patient, or if the device is used for diagnosis in clinical situations where the patient is at immediate risk, they are classified as [Class IIb]
  • Rule 11
    • Software intended to provide information for making decisions for diagnostic or therapeutic purposes is classified as [Class IIa], except in the following cases:
    • – [Class III] if such decisions may result in death or an irreversible deterioration of an individual’s health.
    • – [Class IIb] if such decisions may result in a serious deterioration of health or a surgical intervention.
    • – Software intended to monitor physiological processes is classified as [Class IIa], except when monitoring critical physiological variables, such as cardiac activity, respiration, or central nervous system activity, where variations could pose an immediate risk to the patient, in which case it is classified as [Class IIb]
    • – All other software is classified as [Class I]
  • Rule 12
    • All active devices intended to administer or remove medicinal products, body fluids, or other substances to or from the body are classified as [Class IIa], unless the mode of application, considering the nature of the substances involved, the part of the body, and the method of application, poses potential risks, in which case they are classified as [Class IIb].

  • Rule 13
    • All other active devices are classified as [Class I].
  •  
Special Rules
  • Rule 14
    • Devices incorporating, as an integral part, a substance that, when used separately, may be considered a medicinal product as defined in Article 1(2) of Directive 2001/83/EC, including medicinal products derived from human blood or plasma as defined in Article 1(10) of that Directive, and that has an ancillary role in the device, are classified as [Class III]

  • Rule 15
    • All devices intended for contraception or prevention of sexually transmitted diseases are classified as [Class IIb], except for implantable devices or devices intended for long-term use, which are classified as [Class III]

  • Rule 16
  • – All devices intended for the sterilization, cleaning, rinsing, or, where appropriate, hydration of contact lenses are classified as [Class IIb]
  • – All devices specifically intended for disinfecting or sterilizing medical devices are classified as [Class IIa], except for disinfecting solutions or washer disinfectants specifically intended for the final disinfection of invasive devices, which are classified as [Class IIb]
  • – This rule does not apply to devices intended to clean devices other than contact lenses solely by physical means.

  • Rule 17
    • Devices specifically intended for the storage of diagnostic images generated by X-ray radiation are classified as [Class IIa]

  • Rule 18
    • Devices using non-viable or rendered non-viable tissues, cells, or their derivatives of human or animal origin are classified as [Class III], except for devices intended only to come into contact with intact skin

  • Rule 19
    • Devices composed of or incorporating nanomaterials are classified as follows:
    • – [Class III] if they present a high potential for internal exposure
    • – [Class IIb] if they present a medium potential for internal exposure
    • – [Class IIa] if they present a negligible potential for internal exposure
  • Rule 20
    • All devices inserted into the human body via a body orifice, other than surgically invasive devices, and intended for the administration of medicinal products by inhalation are classified as [Class IIa], except when the mode of action of the device has a critical impact on the efficacy and safety of the administered medicinal product or when intended to treat life-threatening conditions, in which case they are classified as [Class IIb]

  • Rule 21
    • Medical devices consisting of substances or combinations of substances that are intended to be introduced into the human body via the oral cavity, or applied to the skin, to be absorbed or locally dispersed, are classified as follows:
    • – [Class III] if their metabolism results in systemic absorption by the body to achieve the intended purpose
    • – [Class III] if they achieve the intended purpose in the stomach or gastrointestinal tract and their metabolites are systemically absorbed by the body.
    • – [Class IIa] if they are applied to the skin, nasal cavity, or oral cavity up to the pharynx and achieve their intended purpose in those body cavities
    • – [Class IIb] in all other cases
    Active therapeutic devices incorporating or integrating a diagnostic function that significantly contributes to patient management decisions, such as closed-loop systems or automated external defibrillators, are classified as [Class III]

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