Hamburg, 22.10.2021, Timo Janssen
On 21.10 2021 two new guidance documents were published by the MDCG. On the one hand MDCG 2021-25, which refers to legacy devices and how to handle them, and on the other MDCG: 2021-26, a Q&A document that answers the question at which point a distributor/importer must assume the obligations of a manufacturer.
For this purpose, MDCG 2021-25 describes the obligations of economic operators regarding legacy devices. Among other things, the handling of systems containing such products is discussed and the preparation of periodic safety update reports are explained. Additionally, the annex of the Guidance provides an overview of all articles in Regulation (EU) 2017/745 that relate to such devices.
MDCG: 2021-26, on the other hand, answers questions for importers and distributors regarding the requirements set out in Article 16 of Regulation (EU) 2017/745. Examples are used to discuss at which point a distributor/importer must assume the obligations of a manufacturer. Furthermore, explanations are given on how to deal with UDIs and at which point a repackaging of products is considered as relabeling.