93 42 Medical Devices Regulation

What is a Medical Device?

A medical device is defined as "any device, apparatus, device or other substance that does not perform by pharmacological, immunological or metabolic means but receives assistance from these means including equipment required for the intended application by the manufacturer; diagnosis, prevention, monitoring, treatment or alleviation of the disease, diagnosis, monitoring, treatment, mitigation or compensation of any injury or disability, examination, modification of the anatomy or physiological process, used alone or together for the control of pregnancy and the main purpose of use on the human body."

93/42 / EC Medical Devices Directive

The regulation published on the production of medical devices determined which products are evaluated within the scope of the regulation, the responsibilities of the manufacturers, and the conditions that the products must comply with before they are put on the market.

In simple terms, what is the purpose of the Medical Device Directive (MDD):

• To define the conditions that medical devices must meet before they are placed on the market,

• Establishing conformity assessment procedures according to device classifications

• Reporting of existing mechanisms to national authorities for monitoring and protecting public health,

If you want to market a medical device within member states of the European Union, the product must comply with the essential requirements of the Medical Devices Directive, MDD 93/42 / EEC + 2007/47 / EC. Harmonized standards (such as EN EMC 60601-1-2: 2001 and EN 60601-1 for electrical safety)

KIOSCERT 2292 provides services in the Medical Devices Regulation within the following scope

-MD 0100 - Generally inactive, non-implanted medical devices

-MD 0101 - Inactive medical devices used for anesthesia, emergency, and intensive care

-MD 0102 - Inactive devices used for injection, infusion, transfusion, and dialysis

-MD 0103 - Inactive orthopedic and rehabilitation devices

-MD 0104 - Inactive medical devices with functional measurement

-MD 0105 - Inactive ophthalmologic devices

-MD 0106 - Inactive devices

-MD 0107 - Contraceptive medical devices

-MD 0108 - Inactive medical devices used for rinsing, cleaning, disinfection

-MD 0109 - Inactive devices for in vitro fertilization (IVF) and assisted reproductive technologies (ART)

-MD 0200 - Inactive implants

-MD 0201 - Inactive cardiovascular implants

-MD 0202 - Inactive orthopedic implants

-MD 0203 - Inactive functional implants

-MD 0204 - Inactive soft tissue implants

-MD 0300 - Devices for wound care

-MD 0301 - Bandage and wound dressing

-MD 0302 - Suture material and clamps

-MD 0303 - Other medical devices for wound care

-MD 0400 - Inactive dental devices and accessories

-MD 0401 - Inactive dental equipment and instruments

-MD 0402 - Dental materials

-MD 0403 - Dental implants

According to the classification rules as MDD Appendix IX in Medical Devices regulation, product classification system

Class I, IIa, IIb, and III

• Class I devices with low risk such as external patient support products

• Class IIa / b. Medium risk devices such as electro-medical devices.

• Class III. High-risk devices such as cardiovascular catheters.