MDR Medical Device Classification

 Medical device are classified based on intended purpose of the devices and their inherent risks. There are 4 classes I, IIa, IIb and III.Below figure shows the MDR 2017/745 risk based classification.

Fig 1.MDR Device Classification

Device class is determined as per Annex VIII .MDR have some additional rules ,definitions.All manufacturers need to reassess their device class as per MDR.

Step 1: Identify duration of contact and degree of invasiveness

Duration of contact:

·      Transient(continuous use for less than 60 minutes)

·       Short term(continuous use for between 60 minutes and 30 days)

·       Long term(continuous use for more than 30 days)

Degree of invasiveness:

·       Invasive

·       Non-Invasive

Step 2: Apply the rules

·       Rules 1-4: Non –invasive devices

·       Rules 5-8:Invasive devices

·       Rules 9-13:Active devices

·       Rules 14-22:Special rules

Article 51 Classification dispute between Notified body and Manufacturer

Competent authority shall address the medical device classification dispute between notified body and manufacturer.

 

 

Fig 2.Classification dispute between Notified body and Manufacturer

Click below link to know more about IVDR device classification:https://meddev-info.blogspot.com/2021/03/ivdr-device-classification.html

Source: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC