Application for an authorisation

Overview of guidelines and forms to be used in connection with clinical investigations of medical devices.

EU/MDCG guidance documents related to clinical investigation:

Here you can find guidance documents published on the website of the European Commission. Especially two guidance documents are relevant in relation to clinical investigations of medical devices:

• MDCG 2021-6 Rev. 1: Regulation (EU) 2017/745 - Questions & Answers regarding clinical investigation
• MDCG 2020-10: Guidance on safety reporting in clinical investigations incl. Appendix: Clinical investigation summary safety report form 

Forms

Application form for authorisation of clinical investigation of medical devices in human subjects 

Until EUDAMED is operational, the sponsor must apply directly to the authorities. In Denmark, you apply for authorisation of clinical investigation to the Danish Medicines Agency by filling out the application form and submitting it by email to the Danish Medicines Agency and the Medical Research Ethics Committees along with all documents.

The application may be in Danish or English. However, the participant information/consent forms must always be in Danish.

The application must be submitted by email along with all documents to both the Danish Medicines Agency and the Medical Research Ethics Committees.

The sponsor may use ZIP compression software to reduce the size of the application. Note that the Danish Medicines Agency can receive a maximum of 50 MB by email, and that you will not necessarily receive a notification if the file is too big for receipt by the agency's server. Alternatively, you may split up the documents and send them by several emails in succession, remembering to write ‘Mail 1 of 4’ or similar in the subject line so that the Danish Medicines Agency and the Medical Research Ethics Committees can easily tell if they have received all emails.