ghtfsg1n063summarytechnicaldocumentationivdsafetyconformity110317文档格式.docx

1、 Date: March 17th, 2011Table of Contents1.0 Introduction 52.0 Rationale, Purpose and Scope 52.1 Rationale 52.2 Purpose 62.3 Scope 63.0 References 64.0 Definitions 75.0 Preparation and Use of the STED 85.1 Preparation 85.2 The Use of the STED in the Premarket Phase 95.3 The Use of the STED in the Pos

2、t-market Phase 115.4 The Use of the STED to Notify Changes to the RA/CAB 116.0 Device Description including Variants （Configurations） and Accessories 126.1 Device Description 126.2 Reference to the Manufacturers Previous Device Generation（s） and/or Similar Devices or Device History 136.2.1 For an IV

3、D medical device not yet available on any market 136.2.2 For an IVD medical device already available on the market in any jurisdiction 137.0 Essential Principles （EP） Checklist 138.0 Risk Analysis and Control Summary 149.0 Design and Manufacturing Information 149.1 Device Design 149.2 Manufacturing

4、Processes 159.3 Manufacturing Sites 1510.0 Product Verification and Validation 1510.1 Analytical Performance 1710.1.1 Specimen type 1710.1.2 Analytical performance characteristics 1810.1.2.1 Accuracy of measurement 1810.1.2.1.1. Trueness of measurement 1810.1.2.1.2. Precision of measurement 1810.1.2

5、.2 Analytical sensitivity 1910.1.2.3 Analytical specificity 1910.1.2.4 Metrological traceability of calibrator and control material values 2010.1.2.5 Measuring range of the assay 2110.1.2.6 Definition of assay cut-off 2110.2 Clinical Performance 2110.3 Stability （excluding specimen stability） 2110.3

6、.1 Claimed shelf life 2210.3.2 In use stability 2210.3.3 Shipping stability 2210.4 Software Verification and Validation 2311.0 Labelling 2312.0 Format of the STED 2313.0 Declaration of Conformity 24Appendix A 25PrefaceThe document herein was produced by the Global Harmonization Task Force, a volunta

7、ry group of representatives from medical device regulatory authorities and the regulated industry. The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development. There are no restrictions on the

8、reproduction, distribution, translation or use of this document. However, incorporation of this document, in part or in whole, into any other document does not convey or represent an endorsement of any kind by the Global Harmonization Task Force. 1.0 IntroductionThe primary way in which the GHTF ach

9、ieves its goals is through the production of a series of guidance documents that together describe a global regulatory model for medical devices, including In Vitro Diagnostic （IVD） medical devices. The purpose of such guidance is to harmonize the documentation and procedures that are used to assess

10、 whether a medical device, including IVD medical device conforms to the regulations that apply in each jurisdiction. Eliminating differences between jurisdictions decreases the cost of gaining regulatory compliance and allows patients earlier access to new technologies and treatments.This document h

11、as been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities （RAs）, Conformity Assessment Bodies （CABs） and industry, and will provide benefits in establishing, in a consistent way, an economic and effective approach to the con

12、trol of medical devices in the interest of public health. It seeks to strike a balance between the responsibilities of Regulatory Authorities to safeguard the health of their citizens and their obligations to avoid placing unnecessary burdens upon the industry.The GHTF has identified as a priority t

13、he need to harmonize the documentation of evidence of conformity to the Essential Principles of safety and performance （hereafter referred to as Essential Principles）. This guideline provides recommendations on the content of summary technical documentation （STED） to be assembled and submitted to a

14、Regulatory Authority or Conformity Assessment Body. It should enable a manufacturer to prepare a STED and provide different Regulatory Authorities or Conformity Assessment Bodies with the same body of documentary evidence that its IVD medical device conforms to the Essential Principles. The use of t

15、he STED should reduce costs for the manufacturer and reviewer, remove barriers to trade and facilitate timely international access to IVD medical devices. Where other guidance documents within the series are referenced within this text, their titles are italicised for clarity. Study Group 1 of the G

16、lobal Harmonization Task Force （GHTF） has prepared this guidance document. Comments or questions about it should be directed to either the Chair or Secretary of GHTF Study Group 1 IVD Subgroup whose contact details may be found on the GHTF website. 2.0 Rationale, Purpose and Scope2.1 RationaleManufa

17、cturers are expected to prepare, and either hold or provide timely access to, technical documentation that shows how each IVD medical device was developed, designed and manufactured. This technical documentation, typically controlled in the manufacturers quality management system （QMS）, is often ext

18、ensive and sections of it may be held in different locations. The documentation is revised to reflect any changes made during the lifecycle of the IVD medical device through normal application of the manufacturers QMS.It is advantageous to both RAs/CABs and the regulated industry if a subset of this

19、 technical documentation is used for selected premarket and post-market conformity assessment activities. This technical documentation subset is intended to be in a consistent, summarised or abridged form, with sufficient detail to allow the RA/CAB to fulfil its obligations. In the main, the documen

20、ts contained within this subset are derived from the technical documentation held by the manufacturer and allow the manufacturer to demonstrate that the IVD medical device to which it applies conforms to the Essential Principles of Safety and Performance of Medical Devices.The availability of such S

21、ummary Technical Documentation （STED） should help eliminate differences in documentation requirements between jurisdictions, thus decreasing the cost of establishing and documenting regulatory compliance and allowing patients earlier access to new technologies and treatments.2.2 PurposeThis document

22、 is intended to provide guidance on the content of the STED for IVD medical devices to be assembled and submitted, where applicable, to a RA or CAB for premarket review, and for use post-market to assess continuing conformity to the Essential Principles. 2.3 ScopeThis document applies to all product

23、s that fall within the definition of an IVD medical device that appears within the GHTF document Principles of In Vitro Diagnostic Medical Devices Classification. 3.0 ReferencesGHTF/SG1/N044:2008 Role of Standards in the Assessment of Medical Devices.GHTF/SG1/N45:2007 Principles of In Vitro Diagnost

24、ic Medical Devices Classification.GHTF/SG1/N29:2005 Information Document Concerning the Definition of the TermMedical Device.GHTF/SG1/N46:2007 Principles of Conformity Assessment for In Vitro Diagnostic Medical Devices.GHTF/SG1/N41:2005 Essential Principles of Safety and Performance of Medical Devic

25、es.GHTF/SG1/N43:2005 Labelling for Medical Devices.4.0 DefinitionsRecognised Standard: Standard deemed to offer the presumption of conformity to specific Essential Principles of safety and performance.Technical Documentation: The documented evidence, normally an output of the quality management syst

26、em, which demonstrates conformity of a device to the Essential Principles of Safety and Performance of Medical Devices.PART 1 PURPOSE OF THE STED5.0 Preparation and Use of the STED5.1 PreparationManufacturers of all Classes of IVD medical devices are expected to demonstrate conformity of the IVD med

27、ical device to the Essential Principles of Safety and Performance of Medical Devices5 through the preparation and holding of technical documentation that shows how each IVD medical device was developed, designed and manufactured together with the descriptions and explanations necessary to understand

28、 the manufacturers determination with respect to such conformity. This technical documentation is revised to reflect the current status of the IVD medical device through normal application of the manufacturers QMS.For the purpose of conformity assessment, the manufacturer assembles the STED from exi

29、sting technical documentation to provide evidence to the RA/CAB that the subject IVD medical device is in conformity with the Essential Principles. The STED reflects the status of the IVD medical device at a particular moment in time （e.g. at the moment of premarket submission or when requested by a

30、 RA for post-market purposes） and is prepared in order to meet regulatory requirements. The flow of information from the technical documentation to the STED is illustrated in Figures 1 and 2. It can be seen from these figures that the content of the STED is the same for both pre and post market use

31、but the circumstances for the use of the STED are different.Where the STED is submitted to a RA/CAB, it should be in a language acceptable to the reviewing organisation.The depth and detail of the information contained in the STED will primarily depend on the classification of the subject IVD medical device.Further considerations when developing the individual sections of the STED include, for instance:a） a high degre