Key takeaways
Derogation authorizations are governed by Article 59 of Regulation EU 745/2017 according to which Member States' competent authorities may authorize, under certain conditions, the placing on the market or putting into service of medical devices for which conformity assessment procedures have not been carried out and whose use is in the interest of patients' health or safety.
In this regard, the Regional Administrative Court stated that such authorizations must be regarded as an "interim and transitional instrument aimed at dealing with extraordinary situations" that would prevent healthcare structures from procuring medical devices through standard procedures.
The Regional Administrative Court pointed out that public tenders represent the standard procure for the procurement of medical device by healthcare structures and, therefore, the launch of a tender procure for the purchase of medical devices excludes by itself the existence of an emergency situation that would justify the use of an extraordinary instrument, such as the derogation authorization.
Lastly, the Regional Administrative Court further clarified that the previous use of the product subject of the public tender does not justify the award of a non CE-marked device since, in such a case, an exceptional procedure would permanently replace the standard one, which requires the obtainment of the CE mark as a condition for placing devices on the market.
