Abstract
Should personal injury arise from the use of POCT, liability is governed in Germany by the general regulations applicable to medical devices. Most claims for damage compensation are filed against manufacturers, operators and users. Essentially, the respondent is sued by the injured party to provide restitutio in integrum. This means restoring the position of a contractual partner’s legal interest that exists outside of the boundaries of the contractual relationship – in this case his physical integrity – to the original state that would have prevailed had that particular injury not occurred. This tier of liability is subject to statutory regulation. The injured party has a right to contractual and non-contractual (tortious) claims for damage compensation. Unlike in the case of pharmaceuticals, there is no separate liability regime governing the product liability to which medical device manufacturers (producers) are subject. Similarly, user and operator liability is regulated in the general statutes (BGB, ProdHaftG).
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Gassner, U.M. (2018). Liability issues relating to POCT. In: Luppa, P.B., Junker, R. (eds) Point-of-Care Testing. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-54497-6_26
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