Abstract
Act will replace national regulations that are based on the current system of medical devices directives (“MDD”). The Act on Medical Devices currently in force will be repealed and replaced by a new Act (the draft is currently being consulted). The new regulations will change the conditions for observational, non-interventional studies in which medical devices are used as intended by the manufacturer (in-label). Today’s law provides for a liberal approach to this type of studies, but from May 2020 they will be treated like full clinical trials, except for the obligation to obtain administrative permission. The article describes this problem and also provides arguments supporting the thesis that such research will not require the prior opinion of the bioethics committee.
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