ENGLISH 24 First of all, the report contains a precise description and intended purpose of the device or device group. This is followed by the strategy of the tests (often as a reference to the biological evaluation plan) and the rationale for the selection of the biological endpoints according to ISO 10993-1 (e.g. Table A.1). It makes sense at this point to include a brief assessment of the results or to establish lines of argument as to why and to what extent it was possible to waive individual tests. An overall conclusion on the biological safety of the medical device should be drawn for both the selection of tests and for the materials chosen for the medical device. Finally, it is important that a separate point in the report addresses each of the requirements laid down in Part 7 of the standard. The biological evaluation report has been included in the standard, along with its recent revision. This took place as part of the efforts to achieve harmonisation with the MDR, which came into force in May 2021. The MDR therefore requires a report in this form. It is necessary for manufacturers of medical devices, especially during the process of obtaining marketing authorisation. A biological evaluation should be carried out even for devices in lower classes or with a lower biological risk, as it enables full assessment of the device and compliance with the legal requirements. Although short, the introductory sentence to Part 7 of the ISO standard is of particular significance. It states: “Expert assessors who have the necessary knowledge and experience shall determine and document [the following]:” But it fails to clarify what actually counts as “necessary knowledge and experience”. Hierarchy of the required tests pursuant to ISO 10993-1 Chemical/ physical characterisation In vitro tests In vivo tests Material characterisation Chemical analysis of leachables and extracables Toxicological characterisation of extractable components/ substances Biological tests Biological evaluation
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