1.0 Device Description including Variants (Configurations) and Accessories
1.1 Device Description
The STED should include the following device descriptive information:
a) the intended use of the IVD medical device. This may include:
1) what is detected
2) its function (e.g. screening, monitoring, diagnosis or aid to diagnosis);
3) the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;
4) whether it is automated or not;
5) whether it is qualitative or quantitative;
6) the type of specimen(s) required (e.g. serum, plasma, whole blood, tissue biopsy, urine);
7) testing population;
b) the intended user (lay person or professional);
c) a general description of the principle of the assay method or instrument principles of operation;
d) the Class of the device and the applicable classification rule according to Principles of In Vitro Diagnostic Medical Devices Classification.
e) a description of the components (e.g. reagents, assay controls and calibrators) and where appropriate, a description of the reactive ingredients of relevant components (such as antibodies, antigens, nucleic acid primers).
and where applicable:
(f) a description of the specimen collection and transport materials provided with the IVD medical device or descriptions of specifications recommended for use;
(g) for instruments of automated assays: a description of the appropriate assay characteristics or dedicated assays;
(h) for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;
(i) a description of any software to be used with the IVD medical device;
(j) a description or complete list of the various configurations/variants of the IVD medical device that will be made available;
(k) a description of the accessories, other IVD medical devices and other products that are not IVD medical devices, which are intended to be used in combination with the IVD medical device.
1.2 Reference to the Manufacturer’s Previous Device Generation(s) and/or Similar Devices or Device History
1.2.1 For an IVD medical device not yet available on any market
Where relevant to demonstrating conformity to the Essential Principles, and to provide general background information, the STED may provide a summary of:
the manufacturer’s previous generation(s) of the IVD medical device, if such exists; and/or
the manufacturer’s similar IVD medical devices available on the market.
1.2.2 For an IVD medical device already available on the market in any jurisdiction
This information may include a summary of the number of adverse event reports related to the safety and performance of this IVD medical device in relation to the number of IVD medical devices placed on the market.
External certificates and documents which give written evidence of conformity with the Essential Principles may be annexed to the STED.
2.0 Essential Principles (EP) Checklist
The STED should include an EP checklist that identifies:
(a) the Essential Principles;
(b) for each Essential Principle whether it applies to the IVD medical device and if not, why not;
(c) the method used to demonstrate conformity with each Essential Principle that applies; and
(d) the reference to the actual technical documentation that offers evidence of conformity with each method used.
3.0 Risk Analysis and Control Summary
The STED should contain a summary of the risks identified during the risk analysis process and a description of how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be based on recognised standards and be part of the manufacturer’s risk management plan.
4.0 Design and Manufacturing Information
4.1 Device Design
The STED should contain information to allow a reviewer to obtain a general understanding of the design applied to the IVD medical device.
4.2 Manufacturing Processes
Only for Class D, the STED should contain information to allow a reviewer to obtain a general understanding of the manufacturing processes.
4.3 Manufacturing Sites
For the activities in 9.2, the STED should identify the sites where these activities are performed.
5.0 Product Verification and Validation
The information provided in the product verification and validation section of the STED will vary in the level of detail as determined by the classification of the device. As a general rule, the STED should summarise the results of verification and validation studies undertaken to demonstrate conformity of the IVD medical device with the Essential Principles that apply to it. Where appropriate, such information might come from the literature.
For the purpose of the STED document, ‘summary’ and ‘detailed information’ are defined as:
Summary Information: A summary should provide enough information to allow the RA/CAB to assess the validity of that information. This summary should contain a brief description of: the study protocol, the study results, the study conclusion.
Detailed Information: Detailed information should include: the complete study protocol, the method of data analysis, the complete study report, the study conclusion.
5.1 Analytical Performance
5.1.1 Specimen type
5.1.2 Analytical performance characteristics
184.108.40.206 Accuracy of measurement
(a) Trueness of measurement
(i) Precision of measurement
220.127.116.11 Analytical sensitivity
18.104.22.168 Analytical specificity
22.214.171.124 Metrological traceability of calibrator and control material values
126.96.36.199 Measuring range of the assay
188.8.131.52 Definition of assay cut-off
5.2 Clinical Performance
5.3 Stability (excluding specimen stability)
5.3.1 Claimed shelf life
5.3.2 In use stability
5.3.3 Shipping stability
5.4 Software Verification and Validation
Source: GHTF/SG1/N063:2011, Summary Technical Documentation (STED) for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices, March 17th, 2011.