Rev 4 of the MEDDEV moves closer to the MDR, but the MDR takes it a little further such as requiring a signed quality agreement to access the equivalent device’s technical information when using an equivalent for a Class III device. Additional updates relate to requirements also in the MDR, like how to conduct a clinical evaluation as well as changing requirements for Notified Bodies. It is expected a Rev 5 of the MEDDEV will be published sometime after the entry into enforcement of the new regulations to align with the new MDR requirements.
