The concept of a medical device is something whose limits are important to define, especially as they affect the technical and legal field of especially sensitive articles. It is also important, on the one hand, because of their close relationship with medicine and on the other, because ultimately, they contribute to maintaining the well-being of human beings.

Not being clear about what a medical device is implies opening the door to a real possibility of error in its manufacture and handling or regarding its distribution, transport or commercialization.

The definition of medical devices

The definition of a medical device must be sought in the legal field. Thus, at present, what is understood by a medical device is limited to Regulation (UE) 2017/745 in whose development it is established what a medical device is.

From article 2, it is deduced that when we speak of a medical device we are referring to instruments, devices, equipment, computer programs, materials or other articles that can be used alone or in combination on human beings in order to:

– Make a diagnosis, prevent, control, treat or alleviate a disease.

– Diagnose, prevent, control, treat, alleviate or compensate for a deficiency or injury.

– Investigate, replace or modify the anatomy or a physiological process.

– Regulate conception.

And that it does not perform the main function that it pursues, within or on the surface of the human body through pharmacological, immunological or metabolic means, but whose function through such means can help.

Included in this concept are the computer programs intended by their manufacturer for diagnostic purposes and which intervene in the proper functioning of these elements.

As you can see, the meaning of a health product or medical device is very broad. Therefore, it is always a good idea to use your classification to clarify ideas.

 

How is a medical device classified?

To know how a medical device is classified, it is necessary to check, on the one hand, the community standard, European Regulation 2017/745 and on the other, the Spanish legal system, Royal Decree 1591/2009 which regulates medical devices.

The intended purpose of use

The purpose for which a medical device is intended is determined on the manufacturer’s labelling as well as in the instructions for use or in the statements made at the time of promotion or sale of the device.

All this information must be contained in the technical file in which it is definitively determined what the product is going to be used for, according to its general requirements of safety and operation. The intention must always be to guarantee the maximum safety of users.

The risks of the product

The classification of a medical device according to the lowest to the highest risk involved is:

 

Class I. Products that do not come into contact with the patient, or do so with intact skin and also those that penetrate through a hole for less than 60 minutes. This category includes, among others, sterile products (gloves, gauze, bandages), reusable surgical products (all kinds of instruments used for operations) or those with a measurement function (traditional thermometers, syringes, spoons or glasses).

 

Class IIa. These products are introduced through a body orifice, or surgically, but not to remain there.

 

Class IIb. This includes some implants, medical devices that affect physiological processes and also those that serve to administer dangerous substances, in addition to those that perform contraceptive functions or are intended for the prevention of sexually transmitted diseases.

 

Class III. These include products that target contact with the central nervous system for therapy and diagnosis but also products that contain medicinal substances, or animal derivatives, in addition to those that are fully absorbed.

 

In vitro diagnostic medical devices are under the scope of their own legislation with Regulation (EU) 2017/746. An example could be pregnancy tests, Covid tests, or sample tubes. Within these terms, a reagent, a calibrating reagent and a kit can be grouped, as well as a piece of equipment or a computer system for the study of samples belonging to the human body.

IP Triana

All aspects of our production faithfully follow the legislation referred to in this text, as well as the quality standards that processes, materials and facilities must follow. All this is reflected in the EU declaration of conformity issued by each family of medical devices that we manufacture.

In the IP Triana catalogue of medical devices, you will find nebulizers, rectal cannulas, vaginal applicators, medicine syringes, measuring cups and graduated plastic spoons.

Contact us and we will inform you of everything you need.

 

More information

 

 

 

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