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EU Commission Extends MDR Transition Period for Certain Class 1 Devices

The EU has approved a “correction” to its Medical Devices Regulation (Regulation (EU) 2017/745, also referenced as the MDR) that effectively extends the transition period for certain Class 1 medical devices.

According to an article posted to the BSI’s Compliance Navigator website in mid-December, the extended transition period specifically applies to those medical devices that are classified at a higher level under the MDR than they were under the EU’s Medical Device Directive (MDD), thereby triggering the need for a review by a Notified Body prior to being placed on the market. The change will allow such devices classified as Class 1 under the MDD holding a Declaration of Conformity dated prior to May 26, 2020 to continue to be placed on the market until May 26, 2024.

The “correction” (“Corrigendum” in EU parlance) was published in the Official Journal of the European Union on December 27.

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Read the online article providing details about the changes to the MDR.

 

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