Hi,
I'm not an "expert" but I've successfully passed the evaluation stage of the technical documentation for MDR. I've included in par. 6.1.b) of my technical documentation exactly what the Regulation asks for (detailed information regarding test design, complete test or study protocols, methods of data analysis, in addition to data summaries and test conclusions) for each item listed in the 6.1.(b), giving justification for what is not applicable:
6.1.b)_1 BIOCOMPATIBILITY
the biocompatibility of the device including the identification of all materials in direct or indirect contact with the patient or user: I've examined my device with reference to the requirements of the 10993 standards and I've explained because it it not applicable (if it is applicable you should describe the test protocol, analysis, results)
6.1.b)_2 PHYISICAL, CHEMICAL AND MICROBIOLOGICAL CHARACTERISATION
6.1.b)_3 ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY
I've discussed the protocol, methods and the result of IEC 60601-1 and IEC 60601-1-2 tests (for example what I've considered as applied part and why, what is the essential performance and why, what are the accessible parts, any deviation respect to the standard requirements, what laboratory I've chosen for the tests, what are the connection with the Risk Analysis, and the results)
6.1.b)_4 SOFTWARE VERIFICATION AND VALIDATION
(describing the software design and development process and evidence of the validation of the software, as used in the finished device. This information shall typically include the summary results of all verification, validation and testing performed both in-house and in a simulated or 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 information supplied by the manufacturer): I've described my SW development plan, the documents generated, the purpose of each test, the SW development instruments, the tests made (unit, integration, system, validation test) and I've provided the list of the reports provided.
6.1.b)_5 STABILITY, INCLUDING SHELF LIFE
description and reference to test
6.1.b)_6 PERFORMANCE AND SAFETY
explanation of the performance, the standards used as reference to define your device's performance, the tests made to verify your device's performance (towards the international standard or other requirements), and the safety aspects (as applicable)
I some case they were an in-depth analysis of the test reports already listed in 6.1.(a)
I've attached all the reference documents (i.e. test reports) in a separate folder, for each section.
