Introduction

Medical device classification under MDR defines the regulatory requirements for a device. It
determines the CE marking route, technical documentation, and conformity assessment
process. Devices are classified based on risk level and intended use.
Medical devices are divided into:
• Class I (Low Risk)
• Class IIa (Medium Risk)
• Class IIb (Higher Risk)
• Class III (High Risk)
Nexus Global supports manufacturers in identifying correct MDR classification.

MDR Device Classes

Class I Devices
Low-risk devices requiring minimal regulatory control.
Requirements: Declaration of Conformity, basic technical documentation.
Class IIa Devices
Medium-risk devices requiring additional control.
Requirements: Technical documentation, Notified Body involvement, CE marking.
Class IIb Devices
Higher-risk devices requiring strict evaluation.
Requirements: Clinical evaluation, risk management, Notified Body audit, CE certification.
Class III Devices
Highest-risk devices with strict regulatory control.
Requirements: Full clinical data, quality system approval, Notified Body assessment, CE
certification.

Device Categories

Non-Invasive Devices
Devices that do not enter the body. Usually Class I.
Invasive Devices
Devices entering the body through natural openings. Usually Class I or IIa depending on use.
Surgically Invasive Devices
Devices entering the body during surgical procedures. Usually Class IIa, IIb, or III based on risk.
Reusable Surgical Instruments
Instruments used repeatedly after sterilization. Usually Class I.
Compliance Requirements
• Class I → Declaration of Conformity
• Class IIa → CE Certificate + Declaration
• Class IIb → CE Certificate + Technical File
• Class III → Full Clinical & Technical Documentation + CE Certificate

Nexus Global Support

Nexus Global provides MDR classification guidance, CE compliance support, technical
documentation assistance, and regulatory consultation for all device classes.