The European Union (EU), in an effort to eliminate trade barriers between member states, is gradually being established as a single, large market that ensures the free movement of people, services, money and products (such as medical devices). In the field of medical devices, the European Commission has formulated three EU directives to replace the original system of recognition of the various members, so that the provisions relating to the placing of such products on the market are harmonized.
The three directives are:
1. Active Implantable Medical Devices Directive (AIMD, 90/335/EEC), applies to active implantable medical devices such as pacemakers, implantable insulin pumps, etc. The AIMD entered into force on January 1, 1993. The transition deadline was December 31, 1994, from January 1, 1995 mandatory implementation.
2. In Vivo In Vivo Diagnostic Devices Directive (IVD) for medical devices for in vitro diagnostic use, such as blood cell counters, pregnancy testing devices, etc.
3. MedicalDevicesDirective (MedicalDevicesDirective, 93/42/EEC), the scope of application is very wide, including in addition to active implantable and in vitro diagnostic devices in addition to almost all the medical devices, such as passive medical devices (dressings, single-use products, contact lenses, blood bags, catheters, etc.); and active medical devices, such as nuclear magnetic **** vibrators, ultrasound diagnostic and therapeutic apparatus, infusion pumps, etc. The directive has been effective since January 1, 1995, the transition deadline for June 13, 1998 from June 14, 1998 mandatory.
The above directive stipulates that after the directive is formally implemented, only medical equipment products with CE marking can be sold in the EU market.
China's medical device manufacturers and export companies in the sale of their products to the EU market, must comply with the provisions of the above directive, affixed with the CE marking, or else the product is difficult to enter the EU market.
Basic Requirements of the Medical Device Directive
The basic requirements described in Appendix I of the MDD include general requirements regarding design and structure. Depending on the intended use, products must fulfill the essential requirements applicable to them. This must be demonstrated by appropriate tests. If a product fulfills the essential requirements, it fulfills the requirements of the Directive. The easiest way to fulfill this requirement is to use the harmonized standards developed by the European Committee for Standardization (CEN) and the European Committee for Technical Standards for Electrical Appliances (CENELEC), whose standards are mostly based on international standards.
EU standards are non-compulsory, as there are often other methods that can be used to demonstrate fulfillment of the basic requirements of their directives. However, the use of harmonized standards gives a great advantage to the manufacturer, as long as the manufacturer's product meets the requirements of the corresponding harmonized standard, it is also considered to meet the essential requirements. It is important to note that the so-called harmonized standards are those European standards that are published in the Official Journal of the European Union.
The main elements of the basic requirements of the MDD are summarized as follows:
General Requirements
--Must be safe;
--Must be designed and manufactured in accordance with currently recognized process technology;
--Must perform as intended;
--Must guarantee the safety and performance of the product for the specified lifetime.
--Appropriate transportation and storage requirements must be specified;
Considering the degree of risk that the design and manufacture of a medical device may pose to the human body, medical devices can be classified into one of the following four categories:
ClassI Lowrisk
ClassIIa Low to Medium Risk (Lowtomediumrisk)
ClassIIb Medium Risk (Mediumrisk)
ClassIII High Risk (Highrisk)
The classification describes the following:
ClassI Low Risk, defined as follows:
b. Non-invasive devices in contact with injured skin for the purpose of stopping exudate
c. Temporary use of invasive devices not exceeding 60 minutes
d. Short-term use of invasive devices in the oral cavity up to the throat and in the ear canal up to the eardrums not exceeding 30 minutes
e. Reusable invasive devices, not exceeding 30 minutes
from the mouth up to the throat and the ear canal up to the eardrums
. e. Reusable surgical appliances
f. Invasive devices implanted in the teeth for a long period of time
g. Active devices that do not belong to Class II
Non-sterile medical devices, such as: examination gloves, examination latex gloves, bandages, surgical tables, surgical lamps, prosthetic limbs, wheelchairs, motorized mobility scooters, hot/cold compresses, medical ___ tools? And so on.
To be sterilized class of medical equipment, such as: surgical sterilization gloves, knives, OK bandage? etc.
ClassIIa low to medium risk, defined as follows:
a. Non-invasive devices for transporting, storing, or injecting blood or body fluids
b. Class IIb(a) devices that directly incorporate filtration, exchange, or heating processes
c. Class I(d) devices for long-term use
d. Active therapeutic devices for controlling or exchanging energy. Active therapeutic devices
e.Active devices for diagnostic purposes which supply visible light energy to be absorbed by the human body and which display images of the distribution of radiopharmaceuticals in the body
f.Sterilization of devices for medical purposes
g.Non-active devices used especially for the recording of diagnostic X-ray charts
For example, surgical gloves, various types of catheters for surgical purposes, catheters for the blood circuits used in dialysis, suction cups, infusion sets, first aid sets, and other devices which are not intended for use in the treatment of patients with chronic illnesses, Suction device, infusion set, first aid respiratory equipment, injection syringe with needle, safety syringe, acupuncture needle, scalp needle, ear thermometer, electronic thermometer, low/middle/high frequency therapy device, infrared electronic therapy device, infrared electronic toothbrush, qi and blood circulating machine, sterilizing pot, contact lenses? etc.
ClassIIb risks, defined as follows:
a. Non-invasive devices used to alter blood, other body fluids or injectable fluids
b. Non-invasive devices used for the subsequent treatment of lacerated epidermal wounds
c. Invasive devices for prolonged use that use ionizing radiation as a source of energy or to produce a biological effect
d. Devices that have a long term use in addition to those in Class I(f). Active devices (e.g., electrosculpture radiation)
e. Devices for birth control or prevention of the transmission of sexually transmitted diseases
f. All devices used for disinfecting, cleaning, and washing of contact lenses
g. Blood bags
e.g., hemodialyzers, oximeters, electrosurgical devices, X-ray machines, ultrasonic spray respiratory therapy, and other devices that are used for the treatment of blood. machine, ultrasonic spray respirator, physiological monitor, bone nail, bone plate, artificial joint, condom, blood bag? etc.
Class III High Risk, defined as follows:
a. Temporary, short-term, and long-term invasive devices for diagnostic and monitoring purposes that come into direct contact with the heart or the central circulatory or neurological system.
b.An invasive device that produces biological effects in the body, undergoes chemical changes, or controls drugs.
c. All devices containing medical substances in accordance with the provisions of Directive 65/65/EEC which may have an effect on the human body in order to assist medical treatment
d. Long-term implantable medical devices.
e.Devices manufactured using non-living animal tissue or its derivatives in contact with injured skin.
Examples include: absorbable surgical sutures, joint injections, brain drainage systems? etc.
Absorbable surgical sutures, joint injections, brain drainage systems, etc.