In-Vitro Diagnostic and Medical Device Classification
Medical device Classification in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC and Medical Device Regulation MDR 2017/745.
European Regulation for CE Marking allows the provision of identifying the Device risk class before initiating with compliance procedures. The new IVDR and MDR details the method in respective sections in the regulation.
Medical Device Classification as per MDR
As per MDR Article 51 Medical Devices are divided into class I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Medical Device Classification are mainly based on the following factors:
- Does the device have a standalone action?
- How long the device is in continuous use in the human body?
- Is it an invasive device or surgically invasive Medical Device?
- Is it an implantable or active medical device
- Does the Medical Device serve the purpose by the use of certain drug?
The Medical Device are classified into:
- Class 1
- Class 1 Sterile
- Class 1 Measuring
- Class 1 Reusable
- Class 11a
- Class 11b
- Class 111
Examples refer to the table below:
| Risk Class | Risk Description | Example |
|---|---|---|
| Class III | High | Drug-eluting cardiac stents, Absorbable Sutures, AIMD |
| Class IIb | Medium-High | Ventilators, orthopedic implants, Radiotherapy equipments |
| Class IIa | Medium-Low | Surgical Blades, Suction equipment |
| Class I sterile | Low | Sterile dressings, Sterile gloves |
| Class I measuring | Low | Volumetric urine bag |
| Class I basic | Low | Non Sterile Gloves |
In Vitro Diagnostic Device Classification as per IVDR
Unlike the new MDR, new IVDR regulations has entirely changed the classification system. This will have a substantial impact on IVD manufacturers as they will need to carry out a gap analysis to determine and level and route for CE Marking.
Examples refer to the table below:
| Risk Class | Risk Description | Example |
|---|---|---|
| A | Low Risk | Specimen receptacles, products for general lab use, accessories with no critical characteristics, culture media, instruments intended for IVD procedures, etc. |
| B | Moderate to Low Risk | Clinical chemistry tests, Self Assessment Devices |
| C | Moderate Risk | Cancer biomarkers, Infectious disease, Genetic testing, Vital screening |
| D | High Risk | High risk blood grouping for transfusion, transplantation, cell administration and detection of infectious load etc.. |
What are Classification Rules as per MDR Annex VIII?
Rules 1 – 4: Non-invasive devices
Rules 5 – 8 : Invasive devices.
Rules 9 – 13 : Active Devices.
Rules 14 – 22 : Special rules.
Is all class I devices exempted from Notified Body Certification?
Yes, class I devices are exempted from Notified Body Certification. Self Declaration permitted.
What is MDR Medical Device reclassification?
Surgical Meshes, Implantable devices coming into contact with the spinal column will be up-classified to Class III.
All active implantable devices and their accessories now in Class III.
Substance based devices intended to be introduced into the human body via a body orifice or applied skin (Rule 21) is now Class IIa.
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