The law on medical devices allows quite complex manufacturing and trading structures to exist, within which entities acting as a legal manufacturer, contract manufacturer or OEM / PLM entities can operate in isolation. In many situations, it may be unclear whether a particular production input (e.g. a sticker on the packaging, a manual translated into Polish, etc.) is part of the “manufacturing process” or not. Certain problems are also caused by the company's qualification in the marketing chain as a distributor or importer.
A mistake in regulatory matters may even involve criminal consequences - in accordance with the applicable law on medical devices, failure to perform required notification activities on time is a criminal indictable offense. Moreover, misinterpretation of regulatory issues in the manual or in the labelling of medical devices may lead to the withdrawal of the medical device from the market in the worst scenario.
Our Law Office has extensive experience in solving legal dilemmas resulting from regulatory issues. Please also read the information on legal support in the notification obligations.