The Approach to Equivalence in the EU

To address manufacturer uncertainty around the acceptability of their biological equivalence strategies under the EU Medical Device Regulation (EU MDR), RQM+ has produced a new guide providing insight into notified body expectations for biological equivalence, as well as a reference tool of potential methodologies.

To make sure that the risk of injury and toxic effects to humans have been addressed for all components in a medical device, notified bodies expect a biological safety evaluation process. The intent behind biological equivalence is to allow medical device manufacturers to leverage clinical data from equivalent devices to assess risks for their own products. However, this is an area of ambiguity for many manufacturers, who may not know how to go about establishing equivalence and providing a clear rationale.


  • EU MDR requirements for biological safety evaluation 
  • Practical approaches to establishing biological equivalence

To access the “Biological Equivalence & the EU MDR Whitepaper” please fill out the form on the page.

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Large multinational medical device manufacturer