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
For more information contact us at info@afpharmaservice.com
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