A new draft for MDCG guidance on the use of equivalence for class III and implantable devices has been released for consultation 🩺

It’s important to note that now a contract is not always required to use equivalence data from another manufacturer’s device in the clinical evaluation of these devices.

This requirement does not apply to legacy devices and WET devices (as defined in Article 61(6) of the MDR), and in many cases, it does not apply to new devices that have not been previously certified under the MDD or AIMDD.

This interpretation of the MDR has been confirmed by commission legal experts. The new MDCG guidance provides further details on the implementation of Articles 61(4)-(6) of the MDR, and it should be beneficial for manufacturers of all types of medical devices, including legacy devices, WET devices, and new products.