top of page
  • Soledad

Examples of Class IIa medical devices

Check the examples of #devices under #MDR #Classification IIa.


Rule 2 - Channelling or storing for eventual administration:

  • 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)

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:

  • 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 4 - Devices that come into contact with injured skin or mucous membrane:

  • 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 5 - Devices invasive with respect to body orifices:

  • Short term corrective contact lenses

  • Tracheal tubes

  • Indwelling urinary catheters intended for short term use

  • Gasses used for insufflation in the body

  • Nasobilliary tubes

  • Orthodontic wires

  • Fixed dental prostheses

  • Fissure sealants guidewires, related introducers and dedicated3 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 7 - Surgically invasive devices intended for short-term use (> 60 min <30 days):

Clamps

  • Infusion cannulae

  • Skin closure devices

  • Temporary filling materials

  • Arthroscopy trocars

  • Insufflation gases for surgically invasive endoscopic procedures

Rule 8 - Implantable devices and long-term surgically invasive devices (> 30 days):

  • Bridges and crowns

  • Dental filling materials and pins

  • Dental alloys, ceramics and polymers

Rule 9 - Active therapeutic devices intended to administer or exchange energy, as well as active devices intended to control/monitor/directly influence certain devices:

  • 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


Rule 10 - Active devices for diagnosis and monitoring or intended for diagnostic or therapeutic radiology:

  • Magnetic resonance equipment

  • Pulp testers

  • Evoked response stimulators

  • Diagnostic ultrasound

  • Gamma cameras

  • Positron emission tomography and single photon emission computer tomography

  • Electrocardiographs

  • Electroencephalographs

  • Electronic thermometers

  • Electronic stethoscopes

  • Electronic blood pressure measuring equipment

Rule 11 – Software intended to provide information to inform decisions with diagnosis or therapeutic purposes or software intended to monitor physiological processes:

  • 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.

  • 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.

Rule 12 - Active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body:

  • Suction pump

  • Feeding pumps

  • Jet injectors for vaccination

Rule 16 - Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices:

  • 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 17 - Devices to record X-ray diagnostic images:

  • Digital x-ray detectors for recording images

  • Photostimulable phosphor plates

  • X-ray films

Rule 19 - Devices incorporating or consisting of nanomaterial

  • 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 - Invasive devices, intended to administer medicinal product by inhalation:

  • 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 21 - Devices composed of substances that are introduced via a body orifice or applied to the skin:

  • 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



15 views0 comments

Recent Posts

See All

Коментарі


bottom of page