EU: Two new MDCG guidelines published

The MDCG has published two additional guidelines in the form of MDCG 2021-25 and MDCG 2021-26, which address the implementation of the MDR for "legacy devices", specifically questions relating to outer packaging/labelling in accordance with Article 16 of the MDR.

MDCG 2021-25 explains the EU's point of view with respect to products that are still placed on the market under the transitional regulations as per Article 120(3) MDR ("legacy devices") and that will no longer be placed on the market after the date of application of the MDR, but can still be sold ("old devices"). It clarifies which regulations of the MDR are considered applicable here and how the distributor's and importer's obligations are to be interpreted.

MDCG 2021-26 is a Q&A document relating to repackaging and labelling in accordance with Article 16 MDR and answers questions relating to these tasks. For instance, it explains that a certificate from a notified body is also required for repackaging/labelling of Class I (or Class A as per the IVDR) products, as these are not explicitly exempt as per Article 16.

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