CLASSIFICATION OF INVITRO DIAGNOSTIC DEVICES ( IVDR CLASSIFICATION )
The IVDR went into effect on May 26, 2017, after a five-year transition period. Manufacturers and developers will have to find new ways to sell their products, and suppliers will have to alter old IVDs to meet new standards. One of the most significant changes in the new legislation is that IVDs are now classified using “risk-based standards,” rather than a pre-determined list of devices.
The following are the major features of the new risk-based classification:
Diagnostic Devices with low personal risk and public risk are classified in class A
Diagnostic Devices with moderate to low personal risk and low public risk are classified in class B
Diagnostic Devices with high personal risk, moderate to low public risk are classified in class C
Diagnostic Devices with high public health risk and high personal risk are classified in class D
MDR CLASSIFICATION (ANNEX VIII)
Medical Devices are classified in the MDR 2017/745 based on possible patient harm. Class III represents the high risk, while Class I represents the lowest risk. Class, I medical devices do not require the involvement of a Notified Body in these elements, but all other Classes do.
Annex VIII outlines a number of key characteristics, listed below, that must be considered to correctly classify a device using the twenty-two classification rules
Duration of contact: The duration that the device is in continuous contact with the patient is defined
- Transient – Less than 60 minutes
- Short term- between 60 minutes to 30 days
- Long term – more than 30 days
Degree of invasiveness
- Invasive Medical Device
- Non-invasive Medical Device
- Implantable Medical Device
GENERAL REQUIRMENTS OF MDR CLASSIFICATION
- All Medical devices must meet the General Safety and Performance requirements
- All Medical devices must be CE marked (except custom-made devices and devices intended for clinical investigation where they should comply with the provisions of Annex XIII of MDR 2017/745)
- Conformity assessment: It is the method by which a manufacturer demonstrates that their devices comply with the requirements of EU MDR 2017/745. The MDR classification will have an impact on the conformity assessment route that the manufacturer should follow in order to affix the CE marking on the medical device.
- As part of the General Safety and Performance requirements, a clinical evaluation in accordance with Annex XIV must be conducted for all medical devices.
To place a medical device on the EU market, a manufacturer needs to comply with General Safety and Performance Requirement of EU regulations, the manufacturer needs to affix a CE mark on the device.
For CE marking, first determine if the medical device falls within the scope of EU Regulation, either as a medical device or as an accessory to a medical device. According to the European framework, there are four classes of medical devices: Class I, IIa, IIb and III. Specific characteristics of the medical device determine its class and respectively how risky it is for the patients
MDR 2017/745 MEDICAL DEVICE CLASSIFICATION RULES
The MDR will include 22 rules, which are four more than the previous Medical Device Directive (MDD). All of the regulations are based on the device’s potential hazards, as well as its technical design and manufacturing methods.
Rule 1– Non-invasive devices
Rule 2 – Non-invasive devices intended for channelling or storing (including cells)
Rule 3 – Non-invasive devices that modify the biological or chemical composition of blood, body liquids, other liquids and cells
Rule 4 – Non-invasive devices in contact with injured skin or mucous membrane
Rule 5 – Devices invasive in body orifices
Rule 6 – Surgically invasive devices for transient/impermanent use
Rule 7 – Surgically invasive devices for short term use
Rule 8 – Surgically invasive devices for long term use and implantable (including any device administering medicinal products, surgical mesh or spinal disc)
Rule 9 – Active therapeutic devices intended to exchange or administer energy
Rule 10 – Active devices for diagnosis and monitoring that emit ionizing radiation
Rule 11 – Software intended to provide information that is used to make decisions with diagnosis or therapeutic purposes (from class I to class III)
Rule 12 – Active devices intended to administer and/or remove medicinal products, body liquids or other substances
Rule 13 – All other active devices
Rule 14 – Devices incorporating a medicinal substance including human blood or plasma
Rule 15 – Contraception or prevention of the transmission of sexually transmitted diseases
Rule 16 – Specific disinfecting, cleaning, and rinsing devices
Rule 17 – Devices specifically intended for recording of diagnostic images generated by X-ray radiation
Rule 18 – Devices utilising non-viable tissues or cells of human origin or tissues of animal or derivatives
Rule 19 – Devices incorporating or consisting of nanomaterial
Rule 20 – Invasive devices with respect to body orifices to administer medicinal products by inhalation
Rule 21 – Substances or combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed
Rule 22 – Active therapeutic devices with an integrated or incorporated diagnostic function that significantly determines the patient management
EU 2017/745 GUIDE
MDR 2017/745
Regulation (EU) 2017/745 of the European parliament and of the Councile
(EU) 2017/746
MDCG 2020-16
Guidance on Classification Rules for in-vitro Diagnostic Medical Devices under Regulation (EU) 2017/746