Medical Device Classification - US and the EU as per MDD, CMDR and GHTF

Instructor: Daniel O Leary
Product ID: 701539
Training Level: Intermediate to Advanced
  • Duration: 75 Min

recorded version

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Read Frequently Asked Questions

The Medical Device Classification webinar explains the classification system in the US, the EU, following the Medial Device Directive (MDD), and the Canadian Medical Device Regulations (CMDR), and the guidance from the Global Harmonization Task Force (GHTF). This is a risk based approach implemented by regulatory authorities.

Why Should You Attend:
In 1976, the FDA received authority to regulate medical devices. The plan, written into law, establishes three risk classes for devices (I, II, and III). The three risk levels require different types of control. The webinar explains the two dimensional system the FDA employs, classifying each device by risk class and associated panel. This leads to specific regulations for each device type.

The EU’s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March 2010. (Note that the classification schemes in the IVDD and AIMDD are the same as the MDD, and are not included in the webinar.)

The Canadian Medical Device Regulations (CMDR) classifies devices into four risk categories (I, II, III, and IV). Classification follows a rule based system set forth in Schedule 1 of the CMDR.

The Global Harmonization Task Force (GHTF) has a guidance document on medical device risk classification that uses four classes (A, B, C, and D) based on risk level. This is a rule based system defined in the guidance document.

Learning objectives:

  • Understand the concepts of risk when applied to medical devices.
  • Describe the US classification system based on Class and Panel.
  • Explain the relationship between device class and control level in the US system.
  • Describe the EU classification system in the MDD.
  • Explain the relationship between device class and conformity assessment paths in the MDD.
  • Describe the CMDR classification system.
  • Explain the specific requirements for each device class.
  • Describe the GHTF device classification system.
  • Explain the relationship between GHTF class and conformity assessment.

Areas Covered in the seminar:

  • The Concepts Of Medical Device Risk
    • Factors that may impact risk
    • Regulatory controls keyed to risk
  • Classification in the US
    • Device Class
    • Device Panel
    • Device type regulation
    • Controls
      • General Controls
      • Special Controls
      • Pre-market Approval
    • FDA Guidance documents
    • Recognized consensus standards
  • Classification in the EU (MDD)
    • Rule based system in MDD Annex IX
    • Changes after March 2010
    • Device class and the EU modules
    • MDD Essential Requirements (Annex I)
    • Harmonized standards
  • Classification in Canada
    • Rule based system in CMDR Schedule 1
    • Specific requirements by device class
  • GHTF Guidance
    • Rule based system in the classification guidance
    • Linkage to the Conformity Assessment guidance

Who will benefit:

This seminar is designed for people involved in the classification, design, development production, and marketing of medical devices. Teams are especially encouraged to attend to help clarify the concepts of device classification. This will also help understanding of global marketing, design inputs and their role, and paths for conformity assessment.People in the following roles can especially benefit from the knowledge in this webinar:
  • Quality Managers
  • Quality Professionals
  • Regulatory Professionals
  • Marketing Managers
  • Marketing Professionals
  • Sales Managers
  • Sales Professionals
  • Risk Managers
  • R&D Managers
  • Design Engineers
  • R&D Project Managers

Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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