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EC MDCG Guidance on Legacy Medical Devices, Repackaging Data

The European Commission’s Medical Device Coordination Group (MDCG) released a document detailing how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices.

Legacy devices should be understood as devices, which, in accordance with Article 120(3) of the MDR, are placed on the market after the MDR’s date of application (DoA) and until 26 May 2024 if certain conditions are fulfilled. Those devices can be:

  • devices which are class I devices under Directive 93/42/EEC (MDD), for which an EC declaration of conformity was drawn up prior to 26 May 2021 and for which the conformity assessment procedure under the MDR requires the involvement of a notified body;

  • devices covered by a valid EC certificate issued in accordance with Directive 90/385/EEC (AIMDD) or the MDD prior to 26 May 2021. ‘Old’ devices are those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the Directives had entered into force.

MDR devices are those that are placed on the market as being in conformity with the MDR other than ‘legacy devices’.

With this document, the task-force reports back to the MDCG about its position on the applicability of MDR requirements to ‘legacy devices’ and ‘old’ devices

In a separate Q&A document, MDCG outlined regulatory obligations for medical devices and in vitro diagnostic (IVD) medical devices related to repackaging and relabeling.


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