As a manufacturer of a medical device that is not yet certified according to the MDR but an interruption of the placing on the market is not in the interest of health protection, you can apply to the BfArM for placing on the market in Germany. The BfArM may authorise this placing on the market in exceptional cases and for a limited period of time. This may be the case if there is no alternative, i.e. the urgent medical need cannot be met by other means and, from a health protection perspective, the completion of a regular conformity assessment procedure for the medical device cannot be awaited. The application is submitted to the BfArM by email. For this purpose, the authority has published the "Annex to the application for special authorisation pursuant to Art. 59 of Regulation (EU) 2017/745 and Art. 54 of Regulation (EU) 2017/746" online.
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