Demonstrating equivalence to an existing, marketed medical device has always been a practical way to show that a new device is safe and effective, and lengthy clinical trials are not required.
Now, the “new” EU MDR introduce a new variation in the concept of “equivalence” for medical devices.
The last paragraph of Par 3 of this Annex, throws a significant spanner in the works:
“[…] It shall be clearly demonstrated that manufacturers have sufficient levels of access to the data relating to devices with which they are claiming equivalence in order to justify their claims of equivalence.”
In practice, this means that the manufacturer should have access to verification and validation data from the “parent” device. If this device is marketed by a different company, then it is easy to understand how accessing a competitor’s technical documentation can be a showstopper, or will require a new set of clinical investigations.
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