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.
Annex XIV, Part A, Clinical Evaluation lists a number of characteristics to be taken into account for the demonstration of equivalence:
Nothing too new here.
But 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.
The intent of the regulator is clear, to try to prevent equivalence claims based on insufficient data, which in the past led to some severe adverse events in the field. Similar indication is also given to the Notified Bodies, ref. Annex VII par 4.5.5 “validity of equivalence claimed in relation to other devices, the demonstration of equivalence, the suitability and conclusions data from equivalent and similar devices,” and Annex IX, par 4.5 “The notified body shall, in circumstances in which the clinical evidence is based partly or totally on data from devices which are claimed to be equivalent to the device under assessment, assess the suitability of using such data, taking into account factors such as new indications and innovation. The notified body shall clearly document its conclusions on the claimed equivalence, and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device claimed as innovative by the manufacturer or for new indications, the notified body shall assess to what extent specific claims are supported by specific pre-clinical and clinical data and risk analysis.”.
Annex X 3.d. lists similar requirements.
The balance is tipped heavily in favor of safety, penalizing innovation, but this was not unexpected. Smaller companies are definitely more likely to suffer from the effects of this requirement that will increase the time to market and add costs related to new clinical investigations.