The Medical Devices Introductory Course 2020

Device Equivalence (2)

Class III and implantable devices – contract is required between different manufacturers Non-implantable and other classes do not require a contract but will need to demonstrate ”sufficient levels of access” MDCG 2020-5 highlights differences between MEDDEV 2.7.1 rev. 4 and MDR • Clinical characteristics include same type of user • Similar kind and duration of contact and similar release characteristics required • Similar (not same) conditions of use • Software algorithms specifically required to be similar Proper scientific justification required

The Organisation for Professionals in Regulatory Affairs

Device Equivalence: Example table extract

Device Equivalence

The Organisation for Professionals in Regulatory Affairs