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An equivalence strategy depends on demonstrable comparability and adequate evidence access, not a competitor catalogue.
MDR equivalence — Define the regulatory scope
MDR Annex XIV and MDCG 2020-5 address technical, biological and clinical equivalence. Applicable Article 61 conditions must also be checked for the specific device.
MDR equivalence — Build the working record
Create a characteristic-by-characteristic table with source documents, differences, clinical significance and access limitations. Distinguish equivalent devices from merely similar devices used to describe the state of the art.
MDR equivalence — Check before release
- Compare materials and tissue contact.
- Check intended purpose and user population.
- Confirm access can support the actual equivalence claim.
MDR equivalence — Record the decision and handover
Approve equivalence only when the evidence chain is sufficient and differences are justified. Escalate unavailable data as a genuine gap and evaluate an alternative clinical evidence strategy rather than filling the table with assumptions.
Frequently asked questions
- Does the same indication prove equivalence?
- No. Technical, biological and clinical characteristics must be assessed together.
- Is a contract always the only access test?
- No. Check the device-specific legal conditions and the sufficiency of access; do not generalise one scenario.