Clinical Evaluation of Equivalent Devices
What extent of data of medical devices from other manufacturers does needed to demonstrate equivalence? Annex XIV (3) EU MDR, for instance, refers to non-implantable devices of risk classes I – IIb. It specifies, that manufacturers must provide clear evidence that they have sufficient access to the data of the device with which they claim equivalence.
Art. 61 para. 5, in contrast, refers to implantable devices or devices in risk class III. It says that two manufacturers need a contract explicitly allowing the manufacturer of the second device full access to the technical documentation on an ongoing basis.
How should we the manufactures do with “sufficient access” and “full access to technical documentation” in common practice by complying with EU MDR requirements.