Article 54/59 derogation – yes, it can be done, but I rather suggest you should try not having to depend on it…
Article 59 MDR/Article 54 IVDR Article 59 (1) says: ‘By way of derogation from Article 52 of this Regulation (…), 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 applicable … Read more
