MDCG 2021-08 Guidance on Clinical Investigation Application and Notification Documents

Medical Devices Coordination Group (MDCG) has published a guidance on clinical investigation Application and Notification documents.

The sponsor of a clinical investigation is required to submit an application / notification to the Member State(s) in which a clinical investigation is to be conducted, accompanied by the documentation referred to in Chapter II of Annex XV, Regulation (EU) 2017/745.

The application / notification is required to be submitted by means of the electronic system referred to in Article 73 of Regulation (EU) 2017/745.

In the absence of the EUDAMED database, a series of clinical investigation application / notification documents have been created. These documents can be downloaded directly from this guide.

DOWNLOAD THE GUIDANCE MDCG 2021-08