Guidance on significant change for legacy devices

All manufacturers making use of the grace period as per the Article 120 (3) of the MDR - with a CE Certificate issued under the MDD/AIMDD - shall carefully read the most recent guidance published by the MDCG.

This is probably one of the most awaited documents as it lays downs what the MDCG considers a "significant change in design or intended purpose" of a device; and in which cases can therefore a manufacturer of legacy devices use the benefit of Article 120(3 . . .


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