| Theme | Clinical evaluation, demonstrating equivalence |
| Target Audience | Manufacturers, notified bodies |
| Products concerned | Products without an intended purpose listed in Annex XVI of MDR |
| Documents mentioned |
MDR (EU) 2017/745 – Annex XIV, Annex XVI Implementing Decision (EU) 2022/2346 – Common specifications non-medical products listed in Annex XVI MDCG 2020-5 – Clinical evaluation , equivalence |
This MDCG guide covers the demonstration of equivalence, based on data pertaining to an already existing device, for products without an intended purpose listed in Annex XVI of MDR and covered by Common Specification (EU) 2022/2346. Three cases are covered:
1) Demonstration of equivalence of a product without an intended purpose vs. a product without an intended purpose
2) Demonstration of equivalence of a product without an intended purpose vs. an analogous medical device
3) Demonstration of equivalence of a product without an intended purpose vs. a dual-purpose device (having both a medical and a non-medical purpose).