体外诊断（IVD）医疗设备分类原理【IMDRF】

　IMDRF/IVD WG/N64FINAL:2021FINAL DOCUMENTTitle: Principles of In Vitro Diagnostic (IVD) MedicalDevices ClassificationAuthoring Group: IMDRF IVD Working GroupDate: 21 January 2021Dr Jeong-Rim Lee, IMDRF ChairThis document was produced by the International Medical Device Regulators Forum. There are norestrictions on the reproduction or use of this document; however, incorporation of this document, inpart or in whole, into another document, or its translation into languages other than English, does notconvey or represent an endorsement of any kind by the International Medical Device RegulatorsForum.Copyright © 2021 by the International Medical Device Regulators Forum

　IMDRF/IVD WG/N64 FINAL: 2021Page 2 of 1621 January 2021Table of Contents1.0 Introduction......................................................................................................................... 42.0 Rationale, Purpose and Scope............................................................................................ 42.1 Rationale................................................................................................................... 42.2 Purpose...................................................................................................................... 52.3 Scope......................................................................................................................... 53.0 References..............................................................................................................................54.0 Definitions............................................................................................................................. 65.0 General Principles................................................................................................................ 96.0 Recommendations and Factors Influencing IVD Medical Device Classification......... 107.0 Proposed General Classification System for IVD Medical Devices............................... 108.0 The Determination of Device Class................................................................................... 129.0 Classification Rules............................................................................................................. 12

　IMDRF/IVD WG/N64 FINAL: 2021Page 3 of 1621 January 2021PrefaceThe document herein was produced by the International Medical Device Regulators Forum(IMDRF), a voluntary group of medical device regulators from around the world. Thedocument has been subject to consultation throughout its development.There are no restrictions on the reproduction, distribution or use of this document; however,incorporation of this document, in part or in whole, into any other document, or its translationinto languages other than English, does not convey or represent an endorsement of any kindby the International Medical Device Regulators Forum.

　IMDRF/IVD WG/N64 FINAL: 2021Page 4 of 1621 January 20211.0 IntroductionThe objective of the International Medical Device Regulators Forum (IMDRF) is toencourage convergence at the global level in the evolution of regulatory systems for medicaldevices in order to facilitate trade whilst preserving the right of participating members toaddress the protection of public health by regulatory means considered to be most suitable.The primary way in which the IMDRF achieves its goals is through the production ofharmonized guidance documents suitable for implementation or adoption by memberRegulatory Authorities, as appropriate taking into account their existing legal framework, orby nations with developing regulatory programmes.This guidance document is one of a series that together describe a global regulatory model formedical devices. Its purpose is to assist a manufacturer to allocate its In Vitro Diagnostic(IVD) medical device to an appropriate risk class using a set of harmonized principles.Regulatory Authorities have the responsibility of ruling upon matters of interpretation for aparticular medical device.This document should be read in conjunction with the GHTF document “Principles ofConformity Assessment for IVD medical devices” that recommends conformity assessmentrequirements appropriate to each of the four (4) risk classes proposed herein. The linkbetween new document on classification and conformity assessment is important to ensure aconsistent approach across all countries/regions adopting the global regulatory modelrecommended by the IMDRF, so that premarket approval for a particular device may becomeacceptable globally. Regulatory Authorities who may have different classification proceduresare encouraged to adopt this IMDRF guidance as the opportunity permits.This document has been developed to encourage and support global convergence ofregulatory systems. It is intended for use by Regulatory Authorities, Conformity AssessmentBodies and industry, and will provide benefits in establishing, in a consistent way, aneconomic and effective approach to the control of medical devices in the interest of publichealth.Regulatory Authorities that are developing classification schemes or amending existing onesare encouraged to consider the adoption of the system described in this document, as this willhelp to reduce the diversity of schemes worldwide and facilitate the process of harmonization.This document supersedes an earlier version produced under the Global Harmonization TaskForce (GHTF) with the same title dated February 19, 2008 (GHTF/SG1/N045:2008).2.0 Rationale, Purpose and Scope2.1 RationaleThis guidance document is one of a series that together describe a global regulatory model formedical devices. It provides guidance on the principles of classification of IVD medicaldevices.

　IMDRF/IVD WG/N64 FINAL: 2021Page 5 of 1621 January 2021Since the inter-relationship between device class and conformity assessment is critical inestablishing a consistent approach to premarket approval across all countries/regions, itshould be read in conjunction with the GHTF document on Principles of ConformityAssessment for In Vitro Diagnostic (IVD) Medical Devices that recommends procedures thatmay be used to demonstrate that an IVD medical device conforms to the Essential Principlesof Safety and Performance for Medical Devices and IVD Medical Devices.2.2 PurposeThe purpose of this document is to● assist a manufacturer to allocate its IVD medical device to an appropriate risk class using aset of harmonized classification principles;● base such classification principles on an IVD medical device’s intended use;● allow Regulatory Authorities to rule upon matters of interpretation for a particular IVDmedical device, when appropriate.Subsequently, such classification will determine the conformity assessment route as describedin the GHTF document on Principles of Conformity Assessment for In Vitro Diagnostic (IVD)Medical Devices.2.3 ScopeThis document applies to all products that fall within the definition of an IVD medical device.NOTE: International reference materials (e.g. WHO) and materials used for external qualityassessment schemes are excluded.3.0 ReferencesGHTF/SG1/N046:2008 Principles of Conformity Assessment for In Vitro Diagnostic (IVD)Medical DevicesIMDRF/GRRP WG/N47FINAL:2018 Essential Principles of Safety and Performance ofMedical Devices and IVD Medical DevicesIMDRF/GRRP WG/N52FINAL:2019 Principles of Labelling for Medical Devices and IVDMedical DevicesIMDRF/SaMD WG/N10FINAL:2013 Software as a Medical Device (SaMD): Key definitionsIMDRF/SaMD WG/N12FINAL:2014 Software as a Medical Device: Possible Frameworkfor Risk Categorization and Corresponding ConsiderationsGHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical DevicesGHTF/SG1/N071:2012 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic(IVD) Medical Device’GHTF/SG5/N8:2012 Clinical Evidence for IVD Medical Devices - Clinical PerformanceStudies for In Vitro Diagnostic Medical Devices

　IMDRF/IVD WG/N64 FINAL: 2021Page 6 of 1621 January 2021Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 onin vitro diagnostic medical devices and repealing Directive 98/79/EC and CommissionDecision 2010/227/EUISO/IEC Guide 51:2014 Safety aspects – Guidelines for their inclusion in standardsISO 18113-1:2009 In vitro diagnostic medical devices - Information supplied by themanufacturer (labelling) – Part 1: Terms, definitions and general requirements.NOTE: Regulations and guidance documents from the organizations represented by allworking group members were considered in the drafting of this document.4.0 DefinitionsAccessory for an IVD Medical Device: article intended explicitly by its manufacturer to beused together with an IVD medical device:- to enable the IVD medical device to achieve its intended purpose: or- to augment or extend the capabilities of the IVD medical device in the fulfilment of itsintended purpose.(ISO 18113-1:2009)Calibration: operation that, under specified conditions in a first step, establishes arelationship between the quantity values with measurement uncertainties provided bymeasurement standards and corresponding measurement indications with associatedmeasurement uncertainties and, in a second step, uses this information to establish arelationship for obtaining a measurement result from an indication.(ISO 18113-1:2009)Calibrator: measurement standard used in the calibration of an IVD test, instrument, orsystem.(ISO 18113-1:2009)Companion Diagnostics Medical Device: an IVD medical device, which is essential for thesafe and effective use of a corresponding medicinal product to:(a) identify, before and/or during treatment, patients who are most likely to benefit from thecorresponding medicinal product; or(b) identify, before and/or during treatment, patients likely to be at increased risk of seriousadverse reactions as a result of treatment with the corresponding medicinal product.NOTE 1: Companion diagnostics are essential for defining patients" eligibility for specifictreatment with a medicinal product through the quantitative or qualitative determination ofspecific markers identifying subjects at a higher risk of developing an adverse reaction to themedicinal product in que...

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