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Examples of Class IIb medical devices

Updated: May 4, 2023

We have prepared the list of examples of medical devices which are class IIb, organized by MDR rules:

Rule 2 - Channelling or storing for eventual administration

  • Blood bags without a substance which, if used separately, can be considered to be a medicinal product

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

  • 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

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

  • 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 5 - Devices invasive with respect to body orifices

  • Urethral stents

  • Long term corrective contact lenses

  • Tracheal cannulae for tracheostoma for long term use

  • Urinary catheters intended for long term use

Rule 6 - Surgically invasive devices intended for transient use (<60 min)

  • Refillable insulin pens

  • Analgesia pumps

  • Viscoelastic solution for ophthalmic surgery

  • 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 7 - Surgically invasive devices intended for short-term use (> 60 min <30 days)

  • Brachytherapy devices

  • Vascular closure devices

  • Haemostatic foams

  • Temporal dialysis catheter, CVVH catheter

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

  • Artificial ligaments for reinforcement

  • Dental implants and abutments

  • Shunts

  • Peripheral stents and peripheral valves

  • Plates

  • Intra-ocular lenses

  • Internal closure devices (including vascular closure devices)

  • 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, viscoelastic surgical devices intended specifically for ophthalmic anterior segment surgery

  • Pedicle screws

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

  • 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)

  • External feedback systems for active therapeutic devices

  • Brachytherapy therapy devices if the device also generates the radiation

  • Therapeutic cyclotrons and linear accelerators

  • Therapeutic X-ray sources

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

  • 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

  • Diagnostic X-Ray machine

  • Computed Tomography Devices

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

  • 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.).

  • Medical devices including MDSW intended to be used for continuous surveillance of vital physiological processes in anaesthesia, intensive care or emergency care.

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

  • 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 15 - Devices used for contraception or prevention of sexually transmitted diseases

  • 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 16 - Specifically disinfecting, cleaning, rinsing, hydrating or sterilising devices

  • Contact lens storing solutions

  • Cleaners for contact lenses

  • Ultraviolet, vibration, or ultrasonic devices for cleaning and disinfecting contact lenses

  • 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 19 - Devices incorporating or consisting of nanomaterial

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

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

  • Simethicone preparations for oral administration

  • Active coal for oral administration

  • Gel for vaginal moisturizing / vaginal lubricants

  • Eye drops for hydration

  • Ear drops

  • 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

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