ARTICLE SUMMARY:
Citing data from another firm’s “equivalent” device to satisfy EU MDR clinical data requirements has until now been thought to be off the table for implantable and Class III devices, but a new guidance document should give companies more leeway to leverage available data without a competitor contract.
One of the initial shocks to medical device manufacturers following the publication of EU MDR was the apparently tightened restrictions around when equivalence can be claimed with another manufacturer’s device.
Most companies, and, more importantly, notified bodies, interpreted Article 61(5) of the MDR as completely prohibiting the practice of using “equivalence” to another firm’s product for implantable and Class III devices, outside of the unlikely circumstance of a company convincing its competitor to sign a contract handing over full access to its technical documentation. Use of equivalence had been routine under the former EU device Directives, and the belief that this pathway was no longer viable has been an important factor pushing more companies out of the European market. (See “EU MDR: Welcome to the New Reality,” Market Pathways, June 27, 2019.)
But a new guidance document published by the EU Medical Device Coordination Group (MDCG) in late December spells out that equivalence can be used for implantable and Class III devices, without a contract, in the vast majority of cases, according to Amie Smirthwaite, PhD, FRAPS, senior VP, scientific affairs at medtech service provider RQM+. Smirthwaite worked on the task force that wrote the guidance.
“It’s a fundamental change to how many were previously understanding these clauses,” says Amie Smirthwaite, from RQM+.
“A manufacturer can always use equivalence without a contract as long as ‘sufficient access’ to the data required to establish equivalence is demonstrated. However, if the device is not legacy, WET [well-established technology], or a design modification of one of your own devices, it may still be necessary to undertake clinical investigations, even if the total clinical data package in the CER is otherwise ‘sufficient,’” notes Smirthwaite, who has been advocating for an updated interpretation of the MDR on this topic since 2021.The guidance also provides examples of what “sufficient access” to this data looks like, in the absence of a contract.
