Medical Device Classification EU & US FDA

EU MDR Medical Device Classification

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 Devices Classification in the European Union new MDR is outlined in ANNEX VIII, Chapter I and classification Rule mentioned in Chapter III. This chapter includes definitions of the terminology used in the medical devices guidance document for the classification of Medical Device.

The Medical Device are classified into:

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


Rules 1 4: Non-invasive devices

Rules 5 8 : Invasive devices.

Rules 9 13 : Active Devices.

Rules 14 22 : Special rules.

Yes, class I devices are exempted from Notified Body Certification. Self Declaration permitted.

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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