What is an unclassified medical device

Classification of medical devices according to DIRECTIVE 93/42 / EEC

What are risk classes? ... basics

Medical devices are classified as follows:

      • Class I (subgroup:Sterile, Is orwith measuring function, short Im)
      • Class IIa (example dentures, electrical stimulation devices, ...)
      • Class IIb (implants (not hip, shoulder, knee), blood bags, condoms, ...)
      • Class III (pacemakers, medical devices containing drugs, absorbable medical devices, hip implants, ...)

The duration and location of the application are decisive for the classification! Usually this means: the longer the product is used, the higher the risk, the higher the classification or the deeper the product is placed in the body, the higher the risk. This risk class is for theCertification crucial. The classification is determined according to Annex IX of Directive 93/42 / EEC. Before a classification is carried out, the following points must be observed:

  • The application of the classification rules depends on the intended use of the products
  • If a product is intended to be used in conjunction with another product, the classification rules are applied to each product separately.
  • Accessories are classified separately regardless of the product with which they are used.
  • Software that controls a product or influences its application is automatically assigned to the same class as the product.
  • If a product is not intended to be used exclusively or mainly on a certain part of the body, it must be classified according to the specified application that contains the highest risk potential.
  • If, taking into account the performance specified by the manufacturer, several rules apply to one and the same product, the strictest rule applies, so that the product is classified in the highest class in each case.
  • When calculating the duration according to Chapter I, Section 1.1, uninterrupted use means actual uninterrupted use of the product in accordance with its intended purpose. If the use of a product is interrupted in order to immediately replace the product with the same or an identical product, this is considered to be the continuation of the uninterrupted use of the product.

There are 18 rules for classifying medical devices. Before starting the classification, the following terms should be known:

Duration of use
Temporarily : Intended for continuous use for less than 60 minutes under normal conditions.
Briefly: Intended for continuous use for up to 30 days under normal conditions.
Long term: Intended for continuous use for more than 30 days under normal conditions.

Degree of invasiveness

Invasive product: Product that penetrates all or part of the body through the surface of the body or through a body opening.
Orifice: A natural opening in the skin, as well as the outer surface of the eyeball or a surgically created permanent opening, such as B. a stoma.

Surgical - invasive product: Invasive product that enters the body through the surface of the body through or in connection with surgery. Products which are not covered by the previous sub-paragraph and which penetrate the body in a way other than through a body opening are treated as surgically invasive products for the purposes of this guideline.

Implantable product: Any product that is intended to be surgically inserted into the human body or - to replace an epithelial surface or the surface of the eye and to remain there after the operation. An implantable product is any product that is intended to be partially inserted into the human body through a surgical procedure and to remain there for at least 30 days after the procedure.

Reusable surgical instrument: An instrument that is not used in connection with an active medical device and is intended for a surgical procedure, the function of which is cutting, drilling, sawing, scraping, scraping, stapling, spreading, stapling or the like and which can be reused after carrying out suitable procedures.

Active medical device: Medical device whose operation depends on a power source or other energy source (with the exception of energy generated directly by the human body or by gravity). A product that is used to transfer energy, substances or parameters between an active medical device and the patient without any significant change in energy, substances or parameters is not regarded as an active medical device. Standalone software is considered an active medical device.

Active therapeutic medical device: Active medical device that is used either separately or in conjunction with other medical devices and is intended to maintain, change, replace or restore biological functions or structures in connection with the treatment or alleviation of a disease, wound or disability.

Active diagnostic medical device: Active medical device that is used either separately or in conjunction with other medical devices and is intended to provide information for the detection, diagnosis, monitoring or treatment of physiological conditions, health conditions, disease states or congenital malformations.

Central circulatory system: The following vessels fall under the "central circulatory system": Arteriae pulmonales, ascending aorta, arcus aortae, descending aorta up to the bifurcation of the aortae, arteriae coronariae, arteriae coronariae, arteriae common carotis, arteriae carotis externa, arteria internal carotis, arteriae cerebralus, venaceeuncis, tracheal trunk pulmonary veins, superior vena cava, inferior vena cava.

Central nervous system: In the sense of this guideline, the “central nervous system” is to be understood as follows: brain, meninges and spinal cord.

Details can be found in the document Classification of Medical Devices (corresponds to Annex IX of the Medical Device Directive). In 2007, the Medical Devices Working Group of the ZLG also published guidelines for the classification and classification of medical devices.

MEDDEV paper 2.4 / 1 illustrates the classification in even more detail and with practical examples.