| Theme | Substantial modification of performance study |
| Target Audience | Sponsors, Competent authorities |
| Products concerned | IVD |
| Regulatory reference |
IVDR (EU) 2017/746 Article 66(1) Article 70(1) Article 71 |
| Documents mentioned | MDCG 2022-19 |
As the EUDAMED database is not yet fully functional, the sponsor of a performance study cannot notify the Member State concerned, through the dedicated electronic system, if it intends to introduce changes that are likely to have a substantial impact on the safety, health, rights of subjects or on the robustness or reliability of the data generated by the performance study.
In addition to the set of documents created by MDCG 2020-19 for initiating and submitting a performance study request, MDCG 2022-20 provides a template for requesting substantial changes to performance studies.
However, the MDCG reiterates that the use of these forms is voluntary and that national requirements specific to the Member State in which the performance study is to be conducted may apply