Types of nonactive Medical Device implants - What is the origin of this codification?

E

Edugar

Involved In Discussions
In the LIST OF NOTIFIED BODIES UNDER DIRECTIVE 93/42/EEC Medical Devices, medical device codes appear. For example:
MD 0202 - Non-active orthopaedic implants
MD 0203 - Non-active functional implants
MD 0204 - Non-active soft tissue implants​

What is the origin of this codification?
What is the description of Non-active functional implants?

Thanks.
 
E

Edugar

Involved In Discussions
Re: Types of non active implants

Thank you very much, Steve.

Does anyone know the defintion of these implants MD0202 and MD0203?
MD 0202 - Non-active orthopaedic implants
MD 0203 - Non-active functional implants
 
Ronen E

Ronen E

Problem Solver
Moderator
Re: Types of non active implants

Edugar said:
Does anyone know the defintion of these implants MD0202 and MD0203?
MD 0202 - Non-active orthopaedic implants
MD 0203 - Non-active functional implants
Click to expand...

"Active" and "Implantable" devices are defined in the MDD, annex IX:

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. 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.
Click to expand...

Implantable device
Any device which is intended:
— to be totally introduced into the human body or,
— to replace an epithelial surface or the surface of the eye,
by surgical intervention which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body through surgical intervention and intended to remain in place after the procedure for at least 30 days is also considered an implantable device.
Click to expand...
 
E

Edugar

Involved In Discussions
Re: Types of non active implants - What is the origin of this codification?

Thanks Ronen.

In fact the doubt is for the "orthopaedic" and "functional". Any help?
 
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