The Equivalence Route Under EU MDR Is Narrower Than Manufacturers Think

Article 61 of the EU MDR still permits a manufacturer to demonstrate conformity using another device's clinical data instead of running its own clinical investigation. That has not changed since the Medical Device Directive. What has changed is how hard it now is to use it. Under the old directive, equivalence to a competitor's device with a similar public profile was a routine argument. Under MDR, Notified Bodies are applying Annex XIV Part A with a specificity that catches manufacturers who built a technical file on the old assumption.

What equivalence still allows

Annex XIV Part A sets out the test: the device under evaluation and the comparator device must share clinical characteristics (same clinical condition, severity, site of use, patient population, intended purpose), technical characteristics (design, conditions of use, specification, deployment method, materials), and biological characteristics (same materials or substances in contact with the same tissues), to a degree that leaves no clinically significant difference in safety or performance. All three categories have to hold together — a device that is technically near-identical but used in a materially different patient population does not clear the bar, and neither does a device with the same intended purpose built from a different biocompatible material without a case made for why that difference doesn't matter.

Why "sufficient level of access" is the real bar

The clinical-technical-biological test is the part of Article 61 manufacturers usually get right; the part that trips up technical files is the access requirement layered on top of it, particularly for implantable and Class III devices. MDR expects a manufacturer relying on another device's clinical data to hold a genuine, ongoing right to that device's technical documentation — in practice, a contractual arrangement with the device's manufacturer, not a comparison assembled from a competitor's public labeling, marketing claims, or a literature review of its published clinical outcomes. A clinical evaluation report built on the latter will not survive Notified Body scrutiny under the current standard, however similar the devices appear on paper.

• Assuming a public specification sheet is "access." Sufficient access means a documented right to the comparator's technical file, not a summary of what the other manufacturer chose to publish.
• Treating same-manufacturer equivalence as automatic. Even where the comparator is the manufacturer's own earlier device, the equivalence argument still has to be made and documented against Annex XIV Part A — it is easier to support, not exempt.
• Under-specifying the intended purpose comparison. Two devices can share a design and still fail equivalence if the clinical condition, severity, or patient population they are intended for differs in a way that could matter clinically.
• Waiting until Notified Body review to test the argument. An equivalence claim that hasn't been stress-tested against Annex XIV Part A before submission is a finding waiting to happen, not a strategy.

Equivalence was never meant to be a way around clinical data. It is a way of pointing to clinical data you can actually stand behind — which means access to it, not just a resemblance to it. Why access, not similarity, decides the equivalence argument

What this means for the technical file

The European Commission's Medical Device Coordination Group has published guidance on equivalence specifically (MDCG 2020-5), aimed at exactly this gap between the old MDD-era practice and the MDR standard — worth checking against the Commission's current guidance list, since MDCG revises its document set periodically. The practical implication for a technical file is the same regardless of which version is current: an equivalence argument now needs to read like a defensible clinical evaluation on its own terms, with the access arrangement documented alongside the characteristics comparison, not asserted as background.

None of this changes what happens after conformity is established. A device placed on the market through the equivalence route carries the same post-market surveillance and PMCF obligations as one supported by its own clinical investigation — equivalence settles the premarket clinical evidence question, not the ongoing one. Manufacturers who treat the access requirement as a documentation exercise, get it in writing early, and build the safety-and-performance comparison as a first-class part of the MDR technical file rather than a late addition, are the ones whose equivalence claims hold up under review.