MDCG 2021-27 Rev.1 - roles and responsibilities of importers and distributors of medical devices
Medical devices regulation
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MDCG 2021-27 Rev.1 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
First version was issued in Dec 2021
2 years later, the new version!
Questions are renumbered from Q.11 onwards, due to addition of 5 new questions.
Footnotes and sections have been updated or added.
The term ‘legal entity’ is replaced by ‘natural or legal person’ throughout the document
The document is a comprehensive Q&A guide on Articles 13 & 14 of EU Regulations 2017/745 and 2017/746, focusing on the roles and responsibilities of importers and distributors of medical devices. It clarifies definitions, distinguishes between importers and distributors, outlines general and verification obligations, and addresses registration requirements. The document also discusses the applicability of these regulations to various scenarios, including dealing with non-compliant products, reporting obligations, and traceability requirements. Practical examples are provided to illustrate these principles in real-world contexts.
Introduction of the document
This document 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). 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. Activities described in Article 16 of the Regulations are covered in other guidance documents, including MDCG 2018-6, MDCG 2021-23 and MDCG 2021-26.
Note: This document is non-exhaustive and should be read in conjunction with the MDR/IVDR Of additional relevance are the Regulation (EU) 2019/1020 on market surveillance where applicable to the MDR and IVDR, the horizontal guidelines of the European Commission’s ‘Blue Guide’ based on the principles of the New Legislative Framework, and further complementary medical devices sectorial guidance documents.
Example from the document
One practical example from the document is related to the actions an importer should take if they find that an individual medical device already has another importer's details mentioned on its packaging. This scenario addresses the specific responsibilities and steps an importer must take under such circumstances, highlighting the application of the regulations in a real-world situation.
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Since the arrival of Regulation 2017/745, new requirements are requested and form part of the documentation to be presented to the notified body (e.g. review of the in-depth clinical evaluation, PMS procedure, QC results from validation products, proof of staff skills, etc.).
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