By way of derogation from Article 52, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in that Article have not been carried out but use of which is in the interest of public health or patient safety or health.
Toute autre personne participant à la conduite d'une investigation clinique a le niveau d'études, la formation ou l'expérience appropriés dans la discipline médicale concernée et pour ce qui est de la méthodologie de recherche clinique pour accomplir les tâches qui lui incombent.