The European Union Medical Device Regulation (EU MDR) is a new set of rules that will apply to medical devices marketed in the European Union to ensure the quality and safety of the medical device.
According to Article 51 of the MDR, medical devices are classified according to their intended purpose and inherent risks into four groups, class I, IIa, IIb and III. The 22 classification rules are listed in the Annex VIII of the MDR Act. The classification is based on four factors, the duration of contact of the device, the degree of invasiveness, the anatomy affected, and whether the device is active or otherwise. The regulatory requirements for the devices vary according to their inherent risk, with stricter regulations for the devices posing a higher risk to the patient.
Class IIb devices are among the devices that could pose a high risk to the patient. Though most of the devices included in this group are invasive devices, some non-invasive devices are also classified under this group.
Non-invasive devices included under class IIb are the following:
- Blood bags.
- Devices intended to modify the biological or chemical composition of human tissues or cells, blood, other body liquids or other liquids that are intended for future implantation or administration into the body. These include devices like hemodialyzers that remove waste substances from the blood, but do not include devices that bring about this action through filtration, centrifugation or exchanges of gas, heat.
- Dressings used for deep and extensive skin or mucous membrane wounds that heal by secondary intent, that is, the edges of the wound cannot be sutured close to each other but the healing depends on the formation of granulation tissue and sometimes subsequent skin grafting.
Invasive devices that are intended to be used through a natural or surgical opening in the body, including on the external surface of the eyeball, over a long period of time, that is, continuously for more than 30 days (other than those included in class IIa) are classified as class IIb. These may include urethral stents and tracheal cannulas.
Some surgically invasive instruments for transient use may be classified under class IIb due to their hazardous nature if they have a biological effect, are wholly or mainly absorbed. intended to administer medicinal products in a potentially hazardous manner, including those for self application like insulin pens.
Surgically invasive devices intended for short-term use intended to undergo chemical change in the body, except if the devices are placed in the teeth, and those intended to administer medicines are classified as class IIb.
All implantable devices and long-term surgically invasive devices are classified as class IIb except if they are placed in the teeth, where they may be included in a lower class, or which are in direct contact with the heart, the central circulatory system or the central nervous system, have a biological effect or are wholly or mainly absorbed, intended to undergo chemical change in the body in, intended to administer medicinal products, are active implantable devices or their accessories are classified as class IIb devices. These may include nails and plates used in orthopedics, intra-ocular lenses, penile implants, non-absorbable sutures, bone cements, maxillo-facial implants, visco-elastic surgical devices intended specifically for ophthalmic anterior segment surgery are included in this group. However, breast implants, surgical meshes, total or partial joint replacements, and spinal disc replacement implants are included in class III devices.
Active therapeutic devices, that involve the use of energy, are also classified as class IIb. These include those that use kinetic energy like lung ventilators, heat energy like incubators for babies, warming blankets and blood warmers, electrical energy like electrosurgical generators, electrocautery equipment, external pacemakers and defibrillators, electroconvulsive therapy equipment, coherent light like surgical lasers, ultrasound like lithotripters and surgical ultrasound devices, and therapeutic x-ray sources. In addition, surgically invasive instruments that emit ionizing radiation are classified under class IIb, irrespective of whether they are used for transient or short-term use. Devices that are used in brachytherapy treatment, linear accelerators are included in this group. Devices that emit ionizing radiation, even if the radiation is not intended to be released in the body, are also included. An example are catheters, where the intent of the radioisotope is mainly to detect the route of the catheter through the body, except if such catheters are used in the central circulatory system. Devices that are intended to control or monitor the above devices are also included in class IIb.
Other devices classified in class IIb include the following:
- Devices used to diagnose or monitor vital functions in critical conditions.
- Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes if such decisions have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention.
- Active devices intended to administer and/or remove medicinal products, body liquids or other substances to or from the body which could be potentially hazardous. These may include infusion pumps, inhalational devices like nebulizers, ventilators, anesthesia machines and anesthetic vapourisers, 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.
- Contraceptives except in the case of intrauterine devices, which are class III
- Solutions for cleaning, rinsing or disinfecting contact lenses and invasive devices like contact lens solutions, denture disinfecting products, washers-disinfectors for endoscopes, disinfectants for the fluid pathways of haemodialysis equipment, disinfectants for ocular prosthesis, intraosseous transcutaneous amputation prosthesis, surgical equipment and invasive dental equipment
- Devices incorporating or consisting of nanomaterial that present a low potential for internal exposure
- Devices that are composed of substances that are locally dispersed on application, except if they act on the stomach or lower digestive tract, or locally in the nasal or oral cavity as far as the pharynx. Such devices may include antibiotic bone cements, condoms with spermicide, heparin coated catheters, endodontic materials with antibiotics, ophthalmic irrigation solutions which contain components which support the metabolism of the endothelial cells of the cornea, dressings incorporated with an antimicrobial agent.
This article is for informational purposes only and not intended to replace the relationship between the doctor and the patient. It should not be used for self-treatment by patients or by doctors to treat patients. Consult your doctor before using any of the above information.
References:
https://ec.europa.eu/docsroom/documents/10337/attachments/1/translations
Published on 7/9/2020
Updated on 17/11/2020
Copyright: InsiWi Solutions LLP
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