2. Design information, including the determination of the characteristics of the basic materials (materials specifications and CoA of externally sourced materials), buffers formulations, characteristics and limitation of the performance of the devices, methods of manufacture, in-process/semi- product Quality Controls descriptions and QC specifications, final release QC process description and Qc specification,

       3. Risk management and risk analysis, including: Risk analysis report in accordance with EN ISO 14971,

       4. Essential requirements checklist (in accordance to Annex I to Directive 98/79/EC),

       5. Description of the fulfillment of the essential requirements, if not based solely on harmonized standards,

       6. In the case of sterile products or products with a special microbiological state or state of cleanliness, a description of the procedures used,

       7. Performance Evaluation Report(s) confirming the performance parameters of the product declared by the manufacturer together with relevant raw data (test results both form tested products and reference testing methods)) related to this evaluation - for all studies performed, showing the properties stated by the manufacturer, supported by a reference measurement system (if available), together with information on reference methods, reference materials descriptions and reference values (e.g. CoA, method of the virus inactivation in case of virus reference materials, information of the source of material – if they are externally sourced or internally made, etc.), known reference values (e.g. if there are any reference to other available standards), accuracies and units of measurement used (these data should be obtained from studies in a clinical or other appropriate environment, or are the result of an appropriate biographical reference). This refer to both clinical evaluation and analytical performance evaluation.The information provided in the report(s) should meet requirements of the standard ISO 13612.

       8. Performance Evaluation Report with non-professional users (based on lay user performance study on positive and negative subjects and evaluation of IFU by lay-users)

       9. Stability Study Report confirming the stability of the product as declared by the manufacturer together with relevant raw data (test results) related to these studies: accelerated stability studies, real-time stability studies current results or at least plan of the study, in-use stability study report, transport stability studies report,

       10. Instruction for use – in the version which is planned to be provided on EU markets, for all planned brands,14. Production/manufacturing flowchart including details on all manufacturing sites, subsidiaries involved in the process, and all outsources steps, as well as critical suppliers, and critical in-process and final Quality Control points,

       11. List of all suppliers with highlighting suppliers of critical rare components/materials (like MABs, PABS, enzymes etc),

       12. QMS Procedure:

• Procedure for regular review of experience gained with the device subsequent to its being placed on the market – Post Market Surveillance (PMS), the procedure should describe regular verification of the market, in case of covid-19 special attention should be put on the constant monitoring of current pandemic situation, changes in local regulations and requirements to the performance, the virus mutation and its possible influence on the performance of the device, current state of art, as well as usability and safety of the certified product for lay users basing on performance data from market, any complaints and signal from market, etc.

• Vigilance procedure regards: issuance and implementation of advisory notes, dealing in case of medical incidents, notification of competent authorities and NB.

• Production and QC procedures (incoming goods, in-process QC, final product QC/release procedure), and accompanying instructions and QC specifications for semi-products and final products,

• Organizational chart and responsibilities and competencies of the management,

• Design and development, Design Change Control MS procedures.

 Obligatory information that should be delivered to the Notified Body in case of rapid tests for the detection of antibodies against SARS-CoV.

In order to conduct a product for self-testing through certification process in a notified body, we need verifiable evidence confirming the performance of all tests that are the basis for clinical evaluation, stability studies, performance evaluation (including evaluation of the impact of potential interfering substances, cross-reactivity, determination of the limit of detection):

       1. The status of each SARS-CoV-2 positive / negative sample used for testing must be confirmed by a higher-tier test (RT-PCR with CE mark); the results (graphs) for these samples must be provided with the Ct values obtained; evidence / information on the comparative RT-PCR test with the CE mark must be provided (test name, manufacturer, LOT, expiry date, preferably photos of the kits used),

       2. Photos of all performed cassette tests must be provided (well-lit photos, a stopwatch informing about the reading time included, photos not causing difficulties in interpretation),

       3. Evidence should be provided to confirm the preparation of samples with potentially interfering substances - how the concentrations of the substances in question were obtained and what these concentrations were,

       4. Evidence of the origin of the pathogens used in the cross-reactivity studies must be provided. If it was a commercially available panel, the specification of such panel (including information on concentrations), manufacturer's name, batch number, or proof of purchase should be provided. If the pathogen panel has been produced in-house, evidence of the presence and concentration of the pathogen in question should be provided,

       5. Limit of Detection study: supporting evidence for the initial antigen concentration should be provided. What was the initial concentration and how it was measured?

       6. The documentation should include different virus variants recognition analysis and potential influence of different variants on products performance. Also manufacturers approach to continually assess the impact that new genetic variants may have, to ensure that the performance of their devices continues to meet the essential requirements, in accordance with MDCG 2021-7 should be included.

The manufacturer of rapid tests for the detection of antibodies against SARSCoV should meet the specified requirements of MDCG 2021-2 „Guidance on state of the art of COVID-19 rapid antibody tests”.

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