Definition Active Medical Device - Clarification of definition

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RonnyLane

hey there - i need some clarrification about the definition of an active medical device given by 93/42/EEC

MDD 93/42/EEC states in annex IX 1.4:
1.4. Active medical device
Any medical device operation of which depends on a source of electrical
energy or any source of power other than that directly generated by the
human body or gravity and which acts by converting this energy. (...)
In Article 1 "Definition, Scope" it states:
Both medical devices and accessories shall hereinafter be termed devices
Now i'm uncertain about if the above given definition is also applicable to accessories, although it explicitly uses the term "medical devices" instead of just "devices" (as e.g. used in annex IX 1.3)
 

rob73

looking for answers
Re: Clarrification of definition "active medical device"

MDD define accessory as
"‘accessory’ means an article which whilst not being a device is
intended specifically by its manufacturer to be used together with
a device to enable it to be used in accordance with the use of the
device intended by the manufacturer of the device;"
I take it you have an "active accessory" which is not a "medical device" in its own right?
Rob
 
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RonnyLane

Re: Clarrification of definition "active medical device"

I take it you have an "active accessory" which is not a "medical device" in its own right?
Rob

That's correct. I'm thinking about an accessory (as defined in article 1 - 2b) which is "active" (as in "depends on a source of electrical
energy") - without being a "medical device" (which is the term used by annex IX 1.4).

So i'm confused since in some parts the MDD uses the term "medical device" and in some parts only the term "device".
 

rob73

looking for answers
Re: Clarrification of definition "active medical device"

If you could describe the use of the accessory maybe someone out there has an answer. I have not come across this before as all of our accessories are not active.
Rob
 
M

MikeLQSR

Hey Ronny,

In regards to the MDD, the MHRA classifies any medical device AND ITS ACCESSORIES as devices and as such they are both held to the same standard, whether being active or inactive.

Hope that helps!
Mike
 

Marcelo

Inactive Registered Visitor
Now i'm uncertain about if the above given definition is also applicable to accessories, although it explicitly uses the term "medical devices" instead of just "devices" (as e.g. used in annex IX 1.3)

It is.

The following text is from the classification MEDDEV (http://ec.europa.eu/health/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf) which mentions also accessories in this case:

3.1.4. Active medical devices
Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device.

The concept ?act by converting energy? includes conversion of energy in the device and/or conversion at the interface between the device and the tissues or in the tissues.

The concept of ?significant changes? includes changes in the nature, level and density of energy (see Rule 9). This means that for instance an electrode is not an active device under this classification system as long as the energy input is intended to be the same as the energy output. For instance, resistance in a wire that causes minor changes between input and output cannot be considered to constitute "significant change". However, electrodes used in electrosurgery for cutting tissues or cauterisation are active devices because their operation depends on energy provided by a generator and their action is achieved by conversion of energy at the interface between the device and the tissue or in the tissue. Electrodes intended for E.C.G. or E.E.G are normally not active devices because they do not normally act by conversion of energy.

However, it should be understood that an electrode, which is an accessory of an active implant, is covered under the relevant Directive for active implants. Further information on this issue can be found in "Guidelines relating to the application of the Council Directive 90/385/EEC on active implantable medical devices.
The application of energy from the human body does not make a device "active" unless that energy is stored within the device for subsequent release. For instance, energy generated by human muscle and applied to the plunger of a syringe (thus causing a substance to be delivered to a patient) does not make this syringe an "active device". However, if a drug delivery system depends upon manual winding to preload a spring which is subsequently released to deliver a substance, then the device incorporating the spring is an "active device".
Medical devices using prestored gases and/or vacuum as a power source are regarded as active devices, e.g. gas mixers with anaesthesia machines and gas powered suction pumps.

Heating/cooling pads intended only to release stored thermal energy are not active devices because they do not act by conversion of energy. However, heating/cooling pads which act by chemical action (e.g. endothermic or exothermic reaction) are active devices as they are converting chemical energy into heat energy and or vice versa.

Radioactive sources that are intended to deliver ionising radiation are regarded as active medical devices, unless they are radiopharmaceuticals as defined in article 1 of Directive 2001/83/EC or radioactive implants as defined in article 1 of Directive 90/385/EEC.
 
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chandraprabhu.n

I want a clarification that an Electrosurgical Incision Forceps is an active device or not....?
 
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