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. MDR Classification is mainly based on the following factors:
- Does the device have a standalone action?
- How long is the device in continuous use in the human body?
- Is it an invasive device or a surgically invasive Medical Device?
- Is it an implantable or active medical device
- Does the Medical Device serve the purpose of the use of certain drugs?
Type of Risk Class with Example
- Class 1
- Class 1 Sterile
- Class 1 Measuring
- Class 1 Reusable
- Class 11a
- Class 11b
- Class 111
||Drug-eluting cardiac stents, Absorbable Sutures, AIMD
||Ventilators, orthopaedic implants, Radiotherapy equipment
||Surgical Blades, Suction equipment
|Class I sterile
||Sterile dressings, Sterile gloves
|Class, I measuring
||Volumetric urine bag
|Class I basic
MDR Classification and CE Certification Process