Conformity Assessment Procedure

Medical Device Regulation (MDR)

REGULATION (EU) 2017/745, 5 April 2017 on medical devices


Class I (Excl. Is, Im, Ir)

Technical Documentation
  • Annex II(Technical Documentation) and III(Technical document for PMS)

    • ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking
    ▶Periodic Safety Update(PSUR): None


    Custom-made (Excluding Class III implantable device)

    Technical Documentation
  • Annex XIII. Procedure for custom-made device

    • ▶Annex XIV. Part B. Collecting PMS and PMCF information
    ▶Annex XIII Section 1. Declaration
    ▶Periodic Safety Update(PSUR): None


    Custom-made Class III implantable device

    Technical Documentation
  • Annex XIII. Procedure for implantable device

    • Quality Management System
    • Annex IX. Chapter I; or
    • Annex XI – Part A (Production quality assurance)
    ▶Annex XIII Section 1. Declaration
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


    Class Is, Im, Ir

    Technical Documentation
  • Annex II(Technical Documentation) and III(Technical document for PMS)

    • Quality Management System
    • Annex IX. Chapter I, III; or
    • Annex XI – Part A (Production quality assurance)
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): None
    ※ For Class Is, Im, and Ir, the quality management system requirements are limited to aspects related to sterility, measurement, or reusability, as applicable.


    Class IIa

    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex II(Technical Documentation) and III(Technical document for PMS)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Every 2 years


    Class IIb (Classification rule 12)

    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex X (Type examination)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Annex IX Sec. 5 and Annex X Sec. 6. dditional Review Procedure for Clinical Evaluation Reports by Expert Panels
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


    Class IIb Implant *WET and Class IIb non rule 12 (non WET) devices

    *WET: Well Established Technologies. These devices include sutures, staples, dental fillings, braces, dental crowns, screws, wedges, plates, wires, pins, clips, or connectors.
    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex X (Type examination)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


    Class IIb (Implantable, non WET) devices

    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex X (Type examination)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


    Class III Non-implantable Devices (Including Medicinal Substances, Human Tissues, or Animal-derived Substances with TSE Risk)

    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex X (Type examination)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Medicinal Substances (2001/83/EC and EC No 726/2004), Human Tissues (2004/23/EC), TSE Risk (EU No 722/2012) Evaluation
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


    Class III Implantable Devices (Including Medicinal Substances, Human Tissues, or Animal-derived Substances with TSE Risk)

    Technical Documentation
    • 1. Annex IX Chappter II (Assessment of technical document)
    • 2. Annex X (Type examination)
    Quality Management System
    • In case of Technical Documentation No. 1: Annex IX. Chapter I, III
    • In case of Technical Documentation No. 2: Annex XI – Part A(Production Quality Assurance); or
    • In case of Technical Documentation No. 2: Annex XI – Part B(Product Verification)
    ▶Evaluation for Medicinal Substances (2001/83/EC and EC No 726/2004), Human Tissues (2004/23/EC), TSE Risk (EU No 722/2012)
    ▶Annex IX Section 5 and Annex X Section 6: Additional Review Procedure for Clinical Evaluation Reports by Expert Panels
    ▶Annex IV. Declaration of Conformity
    ▶Annex V. CE Marking (Certificate issued by Notified Body)
    ▶Periodic Safety Update(PSUR): Annually


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