European Medical Device Classification

Overview

The European Medical Device Regulation (EU MDR) has a defined approach of safeguarding patient safety in response to technological progress in devices. Medical Device manufacturers complying with the new regulation and transitioning with the changes in the EU MDR are seeing the change in requirements for classification of medical devices in Europe. This revision in European medical device classification will have a comprehensive impact on the manufacturing requirements, clinical evaluation and conformity assessment. The EU medical device classification change impacts the overall interaction and collaboration with the identified Notified Body. All of these aspects are crucial to successfully obtain the CE mark with projected timelines and cost.

Both the Medical Device Directives (MDD) and the EU MDR classification rules place  Medical Devices into one of the following categories:

• Non-invasive Devices
• Invasive Medical Devices
• Active Medical Devices

The European Medical Device Classification segments the devices into the classes noted below.

• Class I – Provided non-sterile or do not have a measuring function (low risk)
  • Class Is: A class I product that is delivered sterile
  • Class Im: A product with a measuring function
  • Class Ir: New sub-class for products that are reprocessed or re-used
• Class IIa (medium risk)
• Class IIb (medium/high risk)
• Class III (high risk)

The EU medical device classification under MDD had a defined 18 rules, whereas with the transition to MDR, the rules have expanded significantly. There are now 22 rules for the EU medical device classification, based on the potential risks associated with the device, technical design and manufacture of the device. In comparison with MDD, the EU MDR medical device classification has introduced new rules for Software as Medical Devices (SaMDs), nanomaterials, inhalers, substances and active devices with diagnostic function.

The new regulation also called the situation of up-classification of certain devices is resulting in wide impact on data and document requirements, along with the Notified Body engagement. All active implantable devices and their accessories will be considered as Class III. Any substance-based device intended to be used via a body orifice or applied on the skin may not be a class I, so any substance-based devices currently in Class I will be up-classified with the new regulation. MDR has also brought into fold, tighter requirements for Medical Device software impacting their classification and approval requirements.