International Medical Device Regulators Forum
- 1. IMDRF/GHTF MRA 203T UNIT 1 Under the guidance of Dr. Lakshmi Prasanthi Nori Professor Department of Regulatory Affairs Presented by: Sheik Rehana 1st M. Pharmacy (Regulatory Affairs) Reg no: 222309 Shri Vishnu College of Pharmacy
- 2. INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) IMDRF is a voluntary group of medical device regulators from around the world. It has come up to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to accelerate international medical device regulatory harmonization. IMDRF was established in October 2011. The establishment and operation of this new Forum was addressed when representatives from the medical device regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan and the United States, as well as the World Health Organization (WHO) met in Ottawa.
- 3. THE CURRENT IMDRF MANAGEMENT COMMITTEE MEMBERS AND REGULATOR AUTHORITY : 1) Australia – Therapeutic Goods Administration 2) Brazil – Brazilian Health Regulatory Agency 3) Canada – Health Canada 4) China – National Medical Products Administration 5) European Union – European Commission – Directorate - General for Health and Food Safety 6) Japan – Pharmaceutical and Medical Devices Agency (PMDA) 7) Russia – Russian Ministry of Health 8) Singapore – Health Science Authority 9) South Korea – Ministry of Food and Drug Safety 10) United Kingdom – Medicines and Healthcare Products Regulatory Agency 11) United States of America – US Food and Drug Administration
- 4. REGIONAL HARMONIZATION INITIATIVES The Asia Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum’s (LSIF) regulatory harmonization steering committee Asian Harmonization Working Party (AHWP) Pan American Health Organization (PAHO) OFFICIAL OBSERVERS Argentina, National Administration of Drugs, Food and Medical Devices World Health Organization (WHO) Swissmedic
- 5. IMDRF CHAIR AND SECRETARIAT The IMDRF Chair and Secretariat rotate on a yearly basis across Management Committee members. The European Union currently holds this responsibility for the year of 2023. Upcoming rotations are as follows: • 2024 - USA • 2025 - Japan • 2026 - Singapore • 2027 - Brazil • 2028 - Canada • 2029 - UK • 2030 - China
- 6. IMDRF MANAGEMENT COMMITTEE (MC) MEETINGS The IMDRF Management Committee (MC) meets four times a year with Closed Session meetings generally held in January, March, June and September. The IMDRF MC may also meet as required if an extraordinary event occurs. They also holds three successive plenary sessions in March and September each year corresponding with the IMDRF MC Closed Sessions. The IMDRF MC Members are expected to attend these face-to-face meetings.
- 7. GLOBAL HARMONIZATION TASK FORCE (GHTF) The GHTF was conceived in 1992 and is an informal grouping that was formed to respond to the growing need for the international harmonization of regulations in medical devices. Since its inception, the GHTF was comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America, each of which actively regulates medical devices using their own unique regulatory framework. The five Founding Members are: European Union, United States, Canada, Australia and Japan. The GHTF disbanded late in 2012. Its mission has been taken over by IMDRF. The organization GHTF, no longer exists.
- 9. ORGANIZATION STRUCTURE Chair's Advisory Group Ad Hoc Working Group Steering Committee
- 10. A. CHAIR’S ADVISORY GROUP (CAG) Ms. Beth Pieterson from Health Canada, volunteered to chair the Ad Hoc Procedures Group (as it came to be called) as part of her role as incoming GHTF Chair.
- 11. The existence of the European proposal prompted the GHTF Chair, Dr. Elizabeth Jacobson, to propose the establishment of a joint industry and regulatory working group to examine the issues of document development, organizational structure, etc. The group would be asked to review all the existing procedural documents and comments and to propose a defined set of practices and procedures whose adoption could be discussed at the 8th Meeting of the GHTF The second meeting of the CAG was held during the 7th Meeting of the GHTF in June 1999 Regulatory representatives from Japan, Australia, the United States, Canada and the European Union were present. At that meeting, a second draft of the GHTF Guiding Principles and Operating Procedures document was presented and representatives from the European Union also presented a proposal for the organizational structure of the GHTF. The inaugural meeting of the Chair’s Advisory Group (CAG) was held in Washington, DC on 16-17 February 1999. At that meeting, plans and agendas were made for the 7th Meeting of the GHTF, which was in the month of June of that year (1999) in Bethesda, Maryland. The group was introduced to a draft document which is prepared by the Food and Drug Administration (FDA) entitled GHTF Guiding Principles and Operating Procedures which proposed an organizational structure for the GHTF and procedures to be followed for document advancement.
- 12. B. AD HOC WORKING GROUPS Ad Hoc Working Groups may be formed at any time by the Steering Committee for the proper fulfilment of its tasks. Ad Hoc Working Groups shall be appointed by the GHTF Chair with the agreement of the Steering Committee. Members of Ad Hoc Working Groups should represent GHTF Founding Members, Regional Members or Participating Members. In some cases, the Ad Hoc Working Group Chair may authorize an individual, with appropriate knowledge and expertise, to participate in an Ad Hoc Working Group meeting(s) as an external observer/expert.
- 13. C. STEERING COMMITTEE The GHTF Steering Committee is established under the Procedural Document, "Roles and Responsibilities". The role of the Steering Committee is to provide policy direction, strategic planning, and to assign and provide oversight of technical work initiatives". Representation on the Steering Committee is limited to up to 4 regulatory and 4 industry members from each founding geographic area - Europe, North America and the Asia-Pacific. The inaugural Steering Committee meeting was held during early 2001 in Sydney, Australia. And it was hosted by the new GHTF Chair (as at January 2001), Ms. Rita Maclachlan of Australia's Therapeutic Goods Administration.
- 14. GHTF PURPOSE These representatives working with medical device manufacturers and other organizations related to medical devices try to harmonize global approaches to the safety, efficacy, clinical performance, and quality of medical devices with the goal of - • protecting public health, • promoting innovation, and • facilitating international trade.
- 15. FUNCTIONS Encouraging the participation of countries and economies other than those of the Founding members and those represented by the Regional Members. Resolving all disputes regarding GHTF decisions or actions brought forward by GHTF members or persons outside the GHTF, with the assistance of the Steering Committee. Representing the GHTF in ad hoc consultations with external parties concerning GHTF activities. Appointing and renewing Study Group Chairs, Vice Chairs and Ad Hoc Working Group Chair. Endorsing final GHTF guidance documents and encouraging their implementation. Monitoring and modifying the institutional rules and procedures of GHTF as needed and in particular the composition of the Steering Committee. Granting status of Regional Members, Participating Members and Liaison Bodies.
- 16. WORKING GROUPS Active working groups 1. Adverse event terminology 2. Good regulatory review practices 3. Medical device cybersecurity guide 4. Personalized medical devices 5. Regulated product submission 6. Software as a medical device Closed working groups 1. Artificial Intelligence Medical Devices 2. Clinical Evidence for IVD Medical Devices 3. Integrating patient registries and innovative tools for enhanced medical device evaluation and tracking 4. Medical Device Clinical Evaluation 5. Principles of In Vitro Diagnostic (IVD) Medical Devices Classification 6. Unique Device Identification (UDI) Application Guide 7. Standards - Improving the quality of international medical device standards for regulatory use
- 17. The purpose of this working group is to: •Improve and harmonize the terminology and systems that are being used to code information relating to medical device adverse events. •To establish IMDRF adverse event terminology composed of the following three parts: i. terms for medical device malfunction, ii. terms for patient/user outcome and iii. terms for part/component of medical device. 1. Adverse Event Terminology • This Good Regulator Review Practices (GRRP) working group develops guidance which help to establish good regulatory review practices for Regulatory Authorities and/or their Conformity Assessment Bodies. • The Review Practices (GRRP) working group aims to improve the effectiveness and efficiency of pre-market review. 2. Good Regulatory Review Practices ACTIVE WORKING GROUPS
- 18. • Medical devices have a potential to impact patient safety. Cybersecurity incidents have made medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities worldwide. • The purpose of this Work Item is to promote a globally harmonized approach to medical device cybersecurity, which ensures the safety and performance of medical devices from fundamental level while encouraging innovation. • The Work Item is thus intended to provide medical device cybersecurity guidance for stakeholders across the device lifecycle. 3. Medical Device Cybersecurity Guide • Advancement in materials science, computational power, imaging and manufacturing technologies are useful in producing medical devices that are designed to meet an individuals needs. These are known as personalized medical devices or PMDs. • The purpose is to develop guidance documents for providing harmonized recommendations for the regulation of PMDs. • The adoption of consistent and harmonized requirements for PMDs will offer significant benefits to users, patients, manufacturers, and regulatory authorities. • The Working Group is currently developing an IMDRF Technical Document which will provide recommendations for production validation of PMDs. The document will provide technical guidance on: i. Validation of the specified design envelope that is one of the defining features of a patient-matched medical device ii. Validation of a Medical Device Production System 4. Personalized Medical Devices (PMD)
- 19. The purpose of this working group is to build - •Table of Contents for medical device regulatory submissions and •To create a template that supports the electronic transmission of regulatory submissions. 5. Regulated Product Submission • The importance of software for medical purposes is increasing in the advancement of public health. • The goal of the Software as a Medical Device (SaMD) Working Group (WG) is to review and refine, the previously published documents, as needed. This is done to ensure: i. consistency, predictability, transparency, and quality of premarket regulatory programs and ii. criteria for assessing premarket technical documentation for SaMD. • The review also pays attention to post-market activities, and also recognizes the speed with which digital health technology develops. 6. Software as a Medical Device
- 20. STUDY GROUP • Premarket Evaluation STUDY GROUP 1 • Post-Market Surveillance/Vigilance STUDY GROUP 2 • Quality system STUDY GROUP 3 • Auditing STUDY GROUP 4 • Clinical safety/performance STUDY GROUP 5
- 21. REGULATORY GUIDELINES 1. Principles of Conformity Assessment for Medical Devices: Conformity assessment is conducted before and after a medical device is placed on the market, and post-market surveillance of devices in actual use. They are intended to provide the evidence of safety, performance, and benefits and risks to maintain public confidence. Conformity assessment is primarily the responsibility of the medical device manufacturer. STUDY GROUP 1
- 22. DEFINITIONS: Conformity Assessment: The systematic examination of evidence generated and procedures undertaken by the manufacturer, under requirements established by the Regulatory Authority, to determine that a medical device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential Principles of Safety and Performance for Medical Devices. Conformity Assessment Body (CAB): A body, other than a Regulatory Authority, engaged in determining whether the relevant requirements in technical regulations or standards are fulfilled. Conformity Assessment Elements: a)Quality management system (QMS) System for post- market surveillance Technical documentation Declaration of conformity Registration of manufacturers and their medical devices by the RA
- 23. PURPOSE: IT PROVIDES GUIDELINES ON: the evidence and procedures that may be used by the manufacturer to demonstrate that a medical device is safe and performs as intended by the manufacturer. the conformity assessment elements that apply to each class of device as the regulatory demands increase with the hazard presented by a particular medical device; the process by which a RA/CAB(Regulatory Authority / Conformity Assessment Bodies) may confirm that such elements are properly applied by the manufacturer; and the manufacturer’s written attestation that it has correctly applied the conformity assessment elements relevant to the classification of the device, i.e. the “Declaration of Conformity”.
- 24. 2. Principles of Medical Devices Classification: To provide a series of principles and rules that allow a medical device to be assigned to one of four classes based on its intended use: CLASS LEVEL DEVICE EXAMPLES A Low Hazard Bandages / tongue depressors B Low-moderate Hazard Hypodermic Needles / suction equipment C Moderate-high Hazard Lung ventilator / bone fixation plate D High Hazard Heart valves / implantable defibrillator
- 25. Structure of the Classification Rules 1. RAs should establish a device classification system consisting of four classes where Class A represents the lowest hazard and Class D the highest. 2. The determination of class should be based on rules derived based on the hazard it presents and based on its intended use. 3. These rules should allow a manufacturer to readily identify the class of its particular medical device subject. 4. The rules should be capable of accommodating future technological developments. 5. The manufacturer should document its justification for placing its product into a particular class. 6. If, based on the manufacturer’s intended use, two or more classification rules apply to the device, the device is allocated the highest level of classification indicated. 7. Where one medical device is intended to be used together with a different medical device, that may or may not be from the same manufacturer, (e.g. a pulse oximeter and a replaceable sensor sourced from a different manufacturer, or a general purpose syringe and a syringe driver), the classification rules should apply separately to each of the devices.
- 26. STUDY GROUP 2 XML (Extensible Markup Language) Schema for Electronic Transfer of Adverse Event Data This XML schema has been developed to facilitate a harmonized method for exchanging an adverse event dataset electronically. National Competent Authorities and manufacturers are encouraged to use this internationally agreed XML schema for exchanging adverse event data. The XML schema allows adverse event data to be completed in English and/or, where necessary, in the language required by the relevant National Competent Authorities. Medical Devices Post Market Surveillance It provides guidelines on: the criteria to be used for deciding when to exchange information with other national competent authorities the procedures to follow when exchanging information the forms to use for exchanging the information Guidance - Content of Field Safety Notices This document identifies elements that should and should not be included in safety related notifications issued by the medical device manufacturer or its representative.
- 27. STUDY GROUP 3 Quality management system - Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers Risk Management Principles and Activities within a QMS QMS - Process Validation Guidance
- 28. STUDY GROUP 4 This gives guidance to regulators and auditing organizations conducting audits of quality management systems of medical device. Scope : This document provides guidance to auditing organizations on planning, organizing, conducting, documenting, and reviewing audit programs for auditing a medical device. To harmonize and provide guidance on planning, organizing, conducting, documenting, and reviewing an audit program for auditing a manufacturer with multiple sites To assist auditors and manufacturers in preparing for, facilitating and responding to audits involving multiple sites To improve the efficiency of audits of a quality management system of a manufacturer with multiple sites Purpose :
- 29. Potential benefits of this document for the regulators or auditing organizations and manufacturer of medical devices include: Improved efficiency of an audit of a quality management system of a manufacturer with multiple sites Reduced audit time and cost for the auditing organization Provision of guidelines for initial audit, surveillance audit, and special audit of a quality management system of a manufacturer with multiple sites
- 30. STUDY GROUP 5 The broad goal for Study Group 5 is to promote the convergence of the regulatory requirements for the generation and presentation of evidence of the clinical safety and performance of medical devices. Clinical investigation - A clinical investigation is defined as “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performance of a medical device.” • ISO 14155-1:2003 Clinical Investigation of Medical Devices for Human Subjects Clinical evaluation: The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer.
- 32. CONCLUSION The IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task Force) play vital roles in advancing global medical device regulations and harmonization efforts. These organizations have significantly contributed to enhancing patient safety, promoting innovation, and facilitating international trade in the medical device industry. To deliver key objectives, IMDRF has prioritized work on: 1. Pre-market 2. Post-market 3. Relationships with stakeholders. By staying at the forefront of regulatory innovation, the IMDRF/GHTF will ensure that patients worldwide have access to safe and effective medical devices.
- 33. QUESTIONS 1. Discuss in detail about GHTF/IMDRF. 2. Write about the organization structure and functions of IMDRF. 3. What are the active working group in IMDRF?
- 34. REFERENCES https://www.imdrf.org/ https://www.imdrf.org/ghtf/mission-summary https://www.imdrf.org/working-groups
- 35. THANK YOU