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Examples of EU Medical Device - Class I

Besides this is not new, we wanted to provide you with the examples of the Medical Device classifications.

Examples of Medical Devices

Rule 1 - Devices that either do not come in direct contact with the patient or contact intact skin only:

  • Devices intended in general for external patient support (e.g. hospital beds, patient hoists, walking aids, wheelchairs, stretchers, dental patient chairs)

  • Body liquid collection devices intended to be used in such a way that a return flow is unlikely (e.g. to collect body wastes such as urine collection bottles, incontinence pads or collectors used with wound drainage devices). They may be connected to the patient by means of catheters and tubing

  • Devices used to immobilise body parts and/or to apply force or compression on them (e.g. non-sterile dressings used to aid the healing of a sprain, plaster of Paris, cervical collars, gravity traction devices, compression hosiery)

  • Corrective spectacle frames (i.e. glasses) and lenses in frames

  • Stethoscopes

  • Eye occlusion plasters

  • Incision drapes

  • Non-invasive conductive gels i.e. ultrasound gels

  • Non-invasive electrodes (electrodes for EEG or ECG)

  • Permanent magnets for removal of ocular debris

  • Wheelchairs pushed by hand

Rule 2 - Channelling or storing for eventual administration:

  • Non-invasive devices that provide a simple channelling function, with gravity providing the force to transport the liquid, e.g. administration sets for infusion

  • Devices intended to be used for a temporary containment or storage function, e.g. cups and spoons specifically intended for administering medicines.

  • Empty syringes without needles

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

  • Wound dressings for skin or mucous, such as: absorbent pads, island dressings, cotton wool, wound strips, adhesive bandages (sticking plasters, band-aid) and gauze dressings which act as a barrier, maintain wound position or absorb exudates from the wound

  • Ostomy bags

  • Dressings for nose bleeds (the purpose of the dressing is not to manage micro-environment) are in class I according to this rule

  • Dental wound dressings not containing animal derived material

Rule 5 - Devices invasive with respect to body orifices :

  • Handheld mirrors used in dentistry to aid in dental diagnosis and surgery

  • Dental impression materials

  • Stomach tubes

  • Impression trays

  • Examination gloves

  • Urinary catheters intended for transient use

  • Embryo transfer catheter and insemination catheter

  • Materials for dental impressions

  • Plastic syringe used to measure a quantity of medicinal product before oral administration to the patient

  • Removable or fixed dental prostheses

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

They are reusable devices and must have the CE mark issued by a Notified Body.

  • Scalpels and scalpel handles

  • Reamers

  • Drill bits

  • Saws, that are not intended for connection to an active device

  • Retractors forceps, excavators and chisels

  • Sternum retractors for transient use

  • Staplers (outside the heart, central circulatory or central nervous system

  • Dental Osteotomes

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

  • Examination lamps

  • Surgical microscopes intended to illuminate the patient’s body in the visible spectrum

  • Dermatoscopes with integrated light sources

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

  • MDSW app intended to support conception by calculating the user’s fertility status based on a validated statistical algorithm. The user inputs health data including basal body temperature (BBT) and menstruation days to track and predict ovulation. The fertility status of the current day is reflected by one of three indicator lights: red (fertile), green (infertile) or yellow (learning phase/cycle fluctuation).

Rule 13 - All other active devices:

  • Electric wheelchairs

  • Dental curing lights

  • Electric hospital beds

  • Patient hoists

  • Dental patient chairs

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

  • Brushes specifically intended to clean medical devices by mechanical action

  • Ultrasonic devices (for other devices than contact lenses)

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