Annex II

1. (a)

   product or trade name and a general description of the device including its intended purpose and intended users;

2. (b)

   the Basic UDI-DI as referred to in Part C of Annex VI assigned by the manufacturer to the device in question, as soon as identification of this device becomes based on a UDI system, or otherwise a clear identification by means of product code, catalogue number or other unambiguous reference allowing traceability;

3. (c)

   the intended purpose of the device which may include information on:

   1. (i)

      what is to be detected and/or measured;

   2. (ii)

      its function such as screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic;

   3. (iii)

      the specific disorder, condition or risk factor of interest that it is intended to detect, define or differentiate;

   4. (iv)

      whether it is automated or not;

   5. (v)

      whether it is qualitative, semi-quantitative or quantitative;

   6. (vi)

      the type of specimen(s) required;

   7. (vii)

      where applicable, the testing population;

   8. (viii)

      the intended user;

   9. (ix)

      in addition, for companion diagnostics, the relevant target population and the associated medicinal product(s).

4. (d)

   the description of the principle of the assay method or the principles of operation of the instrument;

5. (e)

   the rationale for the qualification of the product as a device;

6. (f)

   the risk class of the device and the justification for the classification rule(s) applied in accordance with Annex VIII;

7. (g)

   the description of the components and where appropriate, the description of the reactive ingredients of relevant components such as antibodies, antigens, nucleic acid primers;

   and where applicable:

8. (h)

   the description of the specimen collection and transport materials provided with the device or descriptions of specifications recommended for use;

9. (i)

   for instruments of automated assays: the description of the appropriate assay characteristics or dedicated assays;

10. (j)

    for automated assays: a description of the appropriate instrumentation characteristics or dedicated instrumentation;

11. (k)

    a description of any software to be used with the device;

12. (l)

    a description or complete list of the various configurations/variants of the device that are intended to be made available on the market;

13. (m)

    a description of the accessories for a device, other devices and other products that are not devices, which are intended to be used in combination with the device.

1. (a)

   an overview of the previous generation or generations of the device produced by the manufacturer, where such devices exist;

2. (b)

   an overview of identified similar devices available on the Union or international markets, where such devices exist.

Information to allow the design stages applied to the device to be understood shall include:

1. (a)

   a description of the critical ingredients of the device such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the device;

2. (b)

   for instruments, a description of major subsystems, analytical technology such as operating principles and control mechanisms, dedicated computer hardware and software;

3. (c)

   for instruments and software, an overview of the entire system;

4. (d)

   for software, a description of the data interpretation methodology, namely the algorithm;

5. (e)

   for devices intended for self-testing or near-patient testing, a description of the design aspects that make them suitable for self-testing or near-patient testing.

1. (a)

   information to allow the manufacturing processes such as production, assembly, final product testing, and packaging of the finished device to be understood. More detailed information shall be provided for the audit of the quality management system or other applicable conformity assessment procedures;

2. (b)

   identification of all sites, including suppliers and sub-contractors, where manufacturing activities are performed.

The documentation shall contain the performance evaluation report, which includes the reports on the scientific validity, the analytical and the clinical performance, as referred to in Annex XIII, together with an assessment of those reports.

The clinical performance study documents referred to in Section 2 of Part A of Annex XIII shall be included and/or fully referenced in the technical documentation.

This Section shall describe claimed shelf life, in use stability and shipping stability studies.

The documentation shall contain evidence of the validation of the software, as it is used in the finished device. Such information shall typically include the summary results of all verification, validation and testing performed in-house and applicable in an actual user environment prior to final release. It shall also address all of the different hardware configurations and, where applicable, operating systems identified in the labelling.

1. (a)

   In the case of devices placed on the market in a sterile or defined microbiological condition, a description of the environmental conditions for the relevant manufacturing steps. In the case of devices placed on the market in a sterile condition, a description of the methods used, including the validation reports, with regard to packaging, sterilisation and maintenance of sterility. The validation report shall address bioburden testing, pyrogen testing and, if applicable, testing for sterilant residues.

2. (b)

   In the case of devices containing tissues, cells and substances of animal, human or microbial origin, information on the origin of such material and on the conditions in which it was collected.

3. (c)

   In the case of devices placed on the market with a measuring function, a description of the methods used in order to ensure the accuracy as given in the specifications.

4. (d)

   If the device is to be connected to other equipment in order to operate as intended, a description of the resulting combination including proof that it conforms to the general safety and performance requirements set out in Annex I when connected to any such equipment having regard to the characteristics specified by the manufacturer.