What is a medical device?
The medical products include B. implants, products for injection, infusion, transfusion and dialysis, human medical instruments, medical software, catheters, pacemakers, dental products, dressings, visual aids, X-ray machines, condoms, medical instruments and laboratory diagnostics.
Which aspects have to be dealt with during a briefing?
The briefing covers the intended purpose, proper handling, use and operation of the medical device (including preparation and maintenance – if applicable). It should be noted that the operator can decide that identical devices do not have to be instructed.
When is something a medical device?
Medical device designates an object or a substance that is used for medical, therapeutic or diagnostic purposes for humans, whereby the intended main effect, in contrast to medicinal products, is not primarily pharmacological, metabolic or immunological, but mostly physical or …
When can I use a medical device on humans?
Medical devices may only be used by people who have the necessary training, knowledge and experience. This applies to employees in physiotherapy, podiatry, speech therapy, ergotherapy, psychotherapy, medicine and obstetrics.
Is a toothbrush a medical device?
In most countries, oral care products (toothpaste, toothbrushes, etc.) are considered cosmetics, even though they meet the definition of medical devices.
Are aids medical devices?
“However, most aids are medical products within the meaning of the Medical Products Act and may therefore only be placed on the market and put into operation if they have a CE mark.
What are Appendix 1 medical devices?
Additional requirements for active medical devices according to MPBetreibV Annexes 1 and 2 The devices in Annex 1 include, for example, laser devices, TENS devices, nerve function devices and anesthesia devices. Appendix 2 devices include blood pressure monitors.
How are medical devices classified?
According to the classification rules, medical devices are divided into four risk classes: I, IIa, IIb and III (depending on the risk of use). In addition, there are the subclasses Is (sterile class I products) and Im (class I products with a measuring function).
What is a class 2a medical device?
(2a) Accordingly, an active implantable medical device is any medical device whose operation relies on an electrical energy source or an energy source other than the energy generated directly by the human body or gravity and which is designed to be wholly or partly…
What is covered by the Medical Devices Act?
These include implants, products for injection, infusion, transfusion and dialysis, human medical instruments, software, catheters, cardiac pacemakers, dental products, dressings, visual aids, X-ray machines, condoms, medical instruments, laboratory diagnostics, products for the control of conception and in vitro diagnostics.
What are active implantable medical devices?
Active implantable medical device is any active medical device that is designed to be inserted, in whole or in part, into the human body by surgical or medical intervention, or by medical intervention into a natural orifice and intended to…
Who is responsible for the classification of the medical device?
The definition of medical devices according to Section 3 of the Medical Devices Act (MPG) must be met. The manufacturer or his authorized representative is also responsible for classifying the product. The classification is based on the classification rules of Appendix IX of the EU Directive 93/42/EEC.
Is my product a medical device?
The decision as to whether a product is a medical device must be made on the basis of this definition of the term. As a rule of thumb: If you designate a medical purpose for your product, the product is assigned to the medical devices.
What is an Intended Purpose?
“Intended use” means the use for which a product is intended to be used in accordance with the manufacturer’s claims on the label, in the instructions for use, or in advertising or sales material, or principles of operation and effectiveness of the product (scientifically proven where necessary).
What is an active medical device?
According to the MDR, an active medical device means “a product whose operation depends on a source of energy other than that generated for that purpose by the human body or by gravity and which acts by changing the density or converting that energy.
What is a non-active medical device?
Non-active medical devices include, for example, implants, surgical instruments, aids, bandages, condoms, etc. In vitro diagnostics are medical devices that are used for in vitro testing of samples taken from the human body.
What are invasive medical devices?
Product that enters the body in whole or in part through the body surface or through a body opening. A natural opening in the skin, such as the outer surface of the eyeball, or a surgically created permanent opening, such as a a stoma.
Is a clinical thermometer a medical device?
In the case of medical devices in risk class I (e.g. clinical thermometers, stethoscopes, bandages), the manufacturer’s “self-declaration” is sufficient to place the products on the market. He affixes the CE mark to the product on his own responsibility after compiling the necessary documents.
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