MDCG issues guidance on exemptions from clinical investigations for class III and implantable devices |

https://health.ec.europa.eu/system/files/2023-12/mdcg_2023-7_en.pdf

Among other things it explains that for class III and implantable devices

• “A manufacturer may use clinical data generated from another manufacturer’s ED in the clinical evaluation of the DUE, without a contract” in certain cases,
• “The only requirement in this respect is that the equivalence criteria described in Annex XIV Section 3 are met”, and it emphasizes once more that
• the PMCF plan should be appropriate and “includes post market studies to demonstrate the safety and performance of the DUE” when the clinical evaluation is based on equivalence.

Thereby giving room to device manufacturers to save time and money in their CE-marking process.