ACIG

ENGLISH 24 res, it is of course necessary to consider carefully whether/which specialist literature can be considered, and which contains outdated results. The aim of this is to ensure transparency regarding the literature that has been selected, and to show that the search has been limited and has taken account of the current state of knowledge. Then, when the time comes to update the clinical evaluation in the course of its life cycle – a procedure that is also required by law – the search records will show that the search was conducted without any omissions. Obviously, during the update it is then possible to consider the period that has elapsed between the last evaluation at the current date. As part of this, of course, attention must be given as to whether new findings change anything about the evaluation of the medical product. For example, if it has become known over the course of time that substances or materials used pose a (potenti- al) danger for users or patients, then this must be taken into account and mentioned. Of course, such dramatic discoveries should be identified even before the update and addressed with appropriate action, but this explains the thought process. It is also important to think about criteria for inclusi- on in and exclusion from the literature before the literature search. The as- pects according to which the literature is to be evaluated, and the reasons for excluding certain sources, must be clear before starting. Here too, the decision must be based on scientifically recognised criteria and cannot be arbitrary. A suitable approach is therefore to limit the search to established platforms (e.g. PubMed etc.) or to exclude specialist articles written in langu- ages that those conducting the search do not understand. It is also possible to make exclusions if a search term yields too many matches, e.g. because it is phrased too generally. This also leads us to the next important point: the selection of search terms. Here it is important to make a appropriate selection that delivers sound, trus- ted results about your product (or equivalent products), but which is not so general that the volume of data is no longer manageable. A search term that is too specific can mean that two few results are found, or that conclusions cannot be further substantiated. Choosing the right degree here is therefore a matter of intuitive feeling, sound scientific work and, finally, experience. If there are too few results, the search may need to be extended; on the other hand, if there are too many, other criteria for selection and limitation must be chosen. Figure 1 shows the search procedure suggested by the IMDRF. Here too, gui- delines N56 and MEDDEV 2.7/1 rev. 4 provide recommendations for action that are designed to help track down a publication in terms of its content.