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There are four risk classes (types), Class I, Class IIa, Class IIb, and Class III.


Medical devices that do not come into contact with the patient or that come into contact only with intact skin. Products that penetrate through a body orifice such as the mouth or nose, for temporary use. Such as > Urine bags, bandages, elastic stockings, enemas, or walkers. CE marking consultants


  • Sterile Class I

Examples: Exam gloves, syringes, or reusable surgical instruments.


  • Class I with measurement function


Examples: Non-electronic thermometers or tonometer’s.



This class includes medical devices that are introduced into the human body through a body orifice or by surgical means (through the skin) but are not intended to remain in it, also those that supply energy or substances, or that modify physiological processes as long as it is not carried out in a potentially dangerous way. Non-invasive product disinfectants are included.

Examples: urological probes, needles, cannulas, surgical gloves, contact lenses, hearing aids, or muscle stimulators.



Some implantable products are included (although most of them are class III), products that can influence physiological processes or that administer substances or energy in a potentially dangerous way, and those that are intended for the diagnosis of vital functions. CE Marking for Medical Devices


They include health care products for contraception or prevention of sexually transmitted diseases and disinfectants for invasive products, as well as products for contact lens care.


Examples: Intraocular lenses, blood bags, insulin pens, diagnostic X-ray machines, surgical lasers, anesthesia machines, or condoms.





These include some implantable products, medical devices intended to come into contact with the central nervous system for therapeutic or diagnostic purposes, products containing medicinal substances, products that are fully absorbed, and products containing animal derivatives.


Examples: Heart valves, hip replacement, stents, condoms with spermicide, or collagen dressings.


Others: Customized medical devices, intended for clinical research, self-diagnosis or for “in vitro” diagnosis, and active implantable.


Active implantable:

Medical devices that meet both conditions: to be intended to be implanted in the human body and to be active, they work thanks to a source of energy (pacemakers or defibrillators).


Published at: Recent Health Articleshttp://recenthealtharticles.org

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