ACTIVE MEDICAL DEVICES
IMPLANT MEDICAL DEVICES
DISPOSABLE MEDICAL DEVICES
SOFTWARE MEDICAL DEVICES
IVD MEDICAL DEVICES

Major difference in the definitions of MDR vs MDD

Red marked are the major differences in the MDR requirements.

Term

MDR

Surgically Invasive Device

an invasive device which penetrates inside the body through the surface of the body, including through mucous membranes of body orifices with the aid or in the context of a surgical operation; (Annex VIII)

Injured skin or mucous membrane

means an area of skin or a mucous membrane presenting a pathological change or change following disease or a wound.

Active device

Covered under Article 2 ‘active device’ means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software shall also be deemed to be an active device;

Reusable surgical instrument

Instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection and sterilization have been carried out.

Continuous use

(a) the entire duration of use of the same device without regard to temporary interruption of use during a procedure or temporary removal for purposes such as cleaning or disinfection of the device. Whether the interruption of use or the removal is temporary shall be established in relation to the duration of the use prior to and after the period when the use is interrupted or the device removed; and (b) the accumulated use of a device that is intended by the manufacturer to be replaced immediately with another of the same type

Direct diagnosis

New!!!

A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question by itself or when it provides decisive information for the diagnosis.

Implantable device

Covered under Article 2.5 ‘implantable device’ means any device, including those that are partially or wholly absorbed, which is intended: — to be totally introduced into the human body, or — to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device;

Classification Rules – MDR, Annex VIII

 

 

Rules 1 – 4:

Non-invasive devices

Rules 5 – 8 :

Invasive devices

Rules 9 – 13 :

Active Devices

Rules 14 – 22 :

Special rules

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