07.10.2025
To the attention of all interested parties
Where distributors or importers carry out any of the activities referred to in Article 16(2)(a) and (b) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)/ Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (IVDR), they must inform the ANMDMR of placing the relabeled or repackaged device on the market, in accordance with the provisions of Article 12 of Order of the Minister of Health no. 3539/2022 and Order of the Minister of Health no. 3753/2023, respectively.
The distributor or importer must submit to the ANMDMR a certificate, issued by a notified body designated for the type of devices subject to the activities referred to in Article 16(2)(a) and (b) of the MDR/IVDR, attesting that the distributor’s or importer’s quality management system complies with the requirements set out in Article 16 paragraph (3) of the MDR/IVDR.
Thus, we hereby inform you that only certificates issued by notified bodies, which contain all the information corresponding to the requirements indicated in MDCG 2021- 23 “Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” are accepted.
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