MDCG 2021-27, Rev.1, Guidance for Articles 13 (Importers) & 14 (Distributors) Published
10 January 2024
The Revision 1 of the guidance "Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746" of the Medical Device Coordination Group (MDCG) was published in December 2023.
The introduced amendments to the Guide 2021-27 on operational and practical implementation of Articles 13 and 14 and further related obligations for importers and distributors are listed on page 2 of the document. The obligations described in Article 16 are excluded, being addressed in other MDCG documents: MDCG 2018-6, MDCG 2021-23 and MDCG 2021-26.
The guide begins with the definition of importer and distributor. The decisive factor in distinguishing between these economic operators is the definition of placing on the market and making available on the market. When an operator makes a non-EU manufactured medical device available at the EU market for the first time, the operator becomes an importer with mandatory obligations (more detailed examples and special cases provided in the MDCG 2021-27 document). It is possible for a person to hold the roles of an authorised representative and an importer at the same time, provided the corresponding obligations are fulfilled. Individual stores, pharmacies or individuals can be regarded as potential distributors that also become importers with corresponding obligations as soon as they distribute medical devices from non-EU countries on the EU market for the first time. The obligation to affix the importer information to the product (product packaging or accompanying documents) lies with the importer. The distributor verifies the presence of the importer information on the product. Both distributors and importers are obliged to verify the requirements in accordance with Article 13(2) and 14(2) before placing medical devices on the market – verification methods are described in the guideline.
The MDCG 2021-27 document also addresses reporting obligations of both economic operators and obligations regarding EUDAMED registration. Importers and distributors are obliged to ensure the traceability of medical devices.