As XML and PDF on a data medium
As per March 24th, 2016, the new electronic submission form for initial applications of clinical investigations and performance evaluations will come into effect as an requirement for a valid submission.
The list of fields is based on the mandatory content for the EUDAMED database and addtional information. The electronic form will replace all former paper forms.
NB: Completing the application form does not lead to automatic submission to the BASG. For study notification, the completed application form must be submitted to the BASG as XML and PDF (together with the other required documents) on a data medium.
ENGLISH: L I99 Guidance Document for Clinical Investigations with Medical Devices (en)
GERMAN: I192 Leitfaden für klinische Prüfung mit Medizinprodukten (de)
The application form and all documents required for assessment (Protocol, IB, certificates, ..) need to be submitted in electronic form on an a data medium (e.g. CD).
The data medium and cover letter should be sent to the BASG by regular mail.
NB: Paper version of the dossier no longer required.