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NEWS

8 January 2024

New MDCG Guidelines Regarding Importers and Distributors of Medical Devices

In December 2023, Medical Device Coordination Group (MDCG) issued a revised document, MDCG 2021-27 Rev 1, Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746. The original document MDCG 2021-27, was first issued in December 2021.

 

The MDCG was established by Article 103 of Regulation (EU) 2017/745 and is composed of representatives of all Member States. It is chaired by a representative of the European Commission. All MDCG-endorsed documents and other guidance can be found on the European Comission’s website.

 

MDCG 2021-27 Rev 1 presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). It is non-exhaustive and should be read in conjunction with both regulations. The questions covered by the document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the Regulations. In addition to clarifying several answers, there are also new questions and answers regarding fulfilment service providers, as well as information on the roles of authorised representatives, importers, and distributors.