Medical Device?

‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

-   diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,

-   diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,

-   investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,

-   providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

The following products shall also be deemed to be medical devices:

-   devices for the control or support of conception;

-   products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.

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Medical Device Regulation (EU MDR 2017/745)

This regulation established and adopted by the European Union (EU) in 2017 to ensure the safety and performance of medical devices was created to enhance the previous Medical Device Directive, MDD 93/42/EEC, with the following objectives:

 - Strenthening product safety and performance requirements.

 - Enhancing clinical evaluation and data requirements.

 - Improving traceability and transparency

 - Strengthening post-market surveillance

 - Increasing regulatory compliance responsibilities

 - Expanding the definition and scope of medical devices

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General Safety and Performance Requirement

the requirements that the manufacturers must meet prior to be placed on the market (MDR Annex I)

- Chapter I : General requirements

- Chapter II : Requirements regarding design and manufacture

- Chapter III : Requirements regarding the information supplied with the device

 

Classification 

- Class I : Los-risk devices which are Non-invasive devices such as bandages, surgical instruments,

                and stethoscopes.

- Class Is/Im/Ir : Class I devices which are sterilized, have measuring functions, or are reusables

- Class IIa/IIb : Medium or higher risk devices such as dental fillings, hearing aids, diagnostic ultrasound machines,

                        ventilators, blood bags, and infusion pumps.

- Class III : High-risk devices such as pacemaker, heart valves, and implantale defibrillators.

 

MDA/MDN/MDS/MDT Code

- MDA 0100   Active implantable devices

- MDA 0200   Active non-implantable devices for imagng, monitoring and/or diagnosis

- MDA 0300   Active non-implantable therapeutic devices and general active non-implantable devices

- MDN 1100   Non-active implants and long term surgically invasive devices

- MDN 1200   Non-active non-implantable devices

- MDS 1000   Device with specific characteristics

- MDT 2000   Devices for which speciic technologies or processes are used

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