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
Comments