Market Authorization of Medical Devices in EU

Definition of Medical Devices:

According to the Directive (93/42/EEC), Medical device means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

a.      diagnosis, prevention, monitoring, treatment or alleviation of disease,

b.     diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,

c.      investigation, replacement or modification of the anatomy or of a physiological process,

d.     control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means [1];

 

Classification of Medical Devices (Rule Based):

 

Non-invasive Devices

Invasive Devices

Active Devices

Special Devices

Class Ia

Non-invasive devices which come into contact with injured skin intended to be used as a mechanical barrier, for compression or for absorption of exudates; Except for those devices connected to an active medical device in Class IIa or a higher class or which fall under Class IIa or IIb;

 

Invasive devices intended for transient use through body orifice (not including surgically invasive devices) and which are not intended for connection to an active medical device;

Invasive devices intended for short-term use in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity;

 

Reusable surgical instruments;

 

All active devices, which donít fall under Class IIa, Class IIb and Class III devices;

 

 

Class IIa

Non-invasive devices used in channeling or storing blood, body liquids or tissues, liquids or gases for the purpose of eventual infusion, administration or introduction into the body;

 

Non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids by filtration, centrifugation or exchange of gas or heat, intended for infusion into the body;

 

Non-invasive devices which come into contact with injured skin including devices principally intended to manage the micro-environment of a wound and do not fall under Class I or Class IIb;

 

Invasive devices through body orifices (other than surgically invasive devices) intended for connection to an active medical device in Class IIa or a higher class;

 

Invasive devices intended for short-term use and do not fall under Class I, Class IIb and Class III devices;

 

Invasive devices intended for long-term use in the oral cavity as far as the pharynx, in an ear canal up to the eardrum or in a nasal cavity and are not liable to be absorbed by the mucous membrane;

 

Invasive devices intended for transient use and do not fall under Class I, Class IIb and Class III devices;

 

Active devices intended to supply energy, which will be absorbed by the human body, except for devices used to illuminate the patient's body in the visible spectrum;

 

Active devices intended to image in vivo distribution of radiopharmaceuticals;

 

Active devices intended to allow direct diagnosis or monitoring of vital physiological processes and which do not fall under Class IIb;

 

Active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body not in a potentially hazardous manner.

 

 

Implantable device, which are placed in the teeth;

 

Active therapeutic devices intended to administer or exchange energy and do not fall under Class IIb;

 

All devices intended specifically to be used for disinfecting medical devices other than invasive devices;

 

All devices intended for recording X-ray diagnostic images;

 

 

Class IIb

Non-invasive devices intended for modifying the biological or chemical composition of blood, other body liquids or other liquids intended for infusion into the body and do not fall under Class IIa;

 

Non-invasive devices which come into contact with injured skin intended to be used principally with wounds which have breached the dermis and can only heal by secondary intent;

 

All invasive devices intended for long-term use;

 

Invasive devices intended for transient use to supply energy in the form of ionising radiation;

 

Invasive devices intended for transient use to have a biological effect or to be wholly or mainly absorbed;

 

Invasive devices intended for transient use to administer medicines by means of a delivery system in a manner that is potentially hazardous taking account of the mode of application;

 

Invasive devices intended for short-term use to supply energy in the form of ionising radiation;

 

Invasive devices intended for short-term use to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines;

 

All implantable device and long-term surgically invasive devices;

 

 

Active devices intended to administer or exchange energy in a potentially hazardous way, taking account of the nature, the density and site of application of the energy;

 

Active devices intended to control or monitor the performance of active therapeutic devices in Class IIb;

 

Active devices intended directly to influence the performance of such devices;

 

Active devices specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS;

 

Active devices intended to emit ionizing radiation and intended for diagnostic and therapeutic interventional radiology including devices which control or monitor such devices, or which directly influence their performance;

 

Active devices intended to administer and/or remove medicines, body liquids or other substances to or from the body in a potentially hazardous manner, taking account of the nature of the substances involved, of the part of the body concerned and of the mode of application;

Blood bags;

 

All devices used for contraception or the prevention of the transmission of sexually transmitted diseases, unless they are implantable or long term invasive devices;

 

All devices intended specifically to be used for disinfecting, cleaning, rinsing or, when appropriate, hydrating contact lenses specifically invasive devices;

 

Class III

 

All surgically invasive device:

o   Intended for transient use specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body;

o   Intended for transient use specifically for use in direct contact with the central nervous system;

o   Intended for short use specifically to control, diagnose, monitor or correct a defect of the heart or of the central circulatory system through direct contact with these parts of the body;

o   Intended for short-term use specifically for use in direct contact with the central nervous system;

o   Intended for short-term use to have a biological effect or to be wholly or mainly absorbed;

 

Implantable device and long-term surgical devices:

o   Intended to be used in direct contact with the heart, the central circulatory system or the central nervous system;

o   Intended to have a biological effect or to be wholly or mainly absorbed;

o   Intended to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines;

 

o   All active devices incorporating, as an integral part, a substance which, if used separately, can be considered to be a medicinal product, and which is liable to act on the human body with action ancillary to that of the devices.

o   All active devices incorporating, as an integral part, a human blood derivative.

o   All active implantable or long-term invasive devices used for contraception or the prevention of the transmission of sexually transmitted diseases.

o   All active devices manufactured utilizing animal tissues or derivatives rendered non-viable, except where such devices are intended to come into contact with intact skin only.

o   All active diagnostic devices.

 

 

 

Regulatory Pathway for Medical Devices:

1.     Class I

2.     Class IIa

3.     Class IIb

4.     Class III

 

References:

[1]  Medical Devices Directive (93/42/EEC)