We provide Quality Management System Certification of the Importer / Distributor of medical devices and/or in vitro diagnostic medical devices according to the Art. 16 of the Regulation (EU) 2017/745 on medical devices as amended (hereinafter referred to as „MDR“) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices as amended (hereinafter referred to as „IVDR“) who:

a) provides information (including translation) supplied by the manufacturer, in accordance with Section 23 of Annex I MDR / Section 20 of Annex I IVDR, relating to a medical device / in vitro diagnostic medical device already placed on the market and of further information which is necessary in order to market the medical device / in vitro diagnostic medical device in the relevant Member State;

 b)  makes changes to the outer packaging of a medical device / in vitro diagnostic medical device already placed on the market, including a change of pack size, if the repackaging is necessary in order to market the medical device / in vitro diagnostic medical device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it.

Quality Management System Certification of the Importer / Distributor of medical devices is provided for the types of medical devices stated in the scope of our notification for MDR and IVDR in NANDO database.

In case of interest in our services in the field of Quality Management System Certification of the Importer / Distributor of medical devices according to the MDR or in vitro diagnostic medical devices according to the IVDR, please, send filled document „Application for Certification of Quality Management System of the Importer / Distributor“ and its Annex on e-mail address info@3ec.sk. The general terms and conditions can be viewed at this link.