When submitting your application via DMIDS, please note the following. This will help us to process your application more efficiently and avoid unnecessary requests for additional information or queries:

• Please enclose an explanatory cover letter with your initial application, amendment application and subsequent submissions.
• If you wish to apply for a substantial modification, please summarise the subject of the modification briefly and concisely in the associated free text/comment field. Please avoid referring to the explanatory cover letter in this field.
• Please only upload machine-readable PDF files. Do not submit any scanned documents. Incidentally, you no longer need to submit the signatures of the sponsor or LKP/principal investigator for the inspection plan.
• Please assign the appropriate document type (number + abbreviation) to all attachments to be uploaded. An overview of the documents and their designation in DMIDS that have to be submitted for clinical investigations and performance studies, as well as the above-mentioned document types, can be found under the instructions (“Hinweise zu Anlagen”; only available in German
• Please structure the application as clearly as possible and avoid uploading too many individual documents. If necessary, add your own table of contents.
• Please make sure that the investigational device and the enclosed documents are named consistently throughout the entire application. Avoid alternative device or document names.
• If the investigation plan is changed and thus the version number, the version number must always be updated in the application form as well. Otherwise, there is a risk that the notification refers to an incorrect version number.

How do you correctly structure the clinical investigation plan for clinical investigations according to MDR or the performance study plan for MDR or performance studies according to IVDR?

• The structure should follow Annex XV MDR or the ‘Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices’ (MDCG 2024-3) or Annex XIII IVDR.
• Do not forget to indicate the legal reporting requirements for serious adverse events (SAEs) and device deficiencies correctly according to MDR or IVDR in the investigation plan or performance study plan, even if the investigation is to be conducted outside of Europe.
• Remember also the legal requirements for amendments, the procedure for interruption and early termination (abort).
• Please add the EUDAMED ID in the investigation plan. This is automatically assigned by the system directly after application in DMIDS [SU1] and can in principle already be added during the application procedure at the ethics commission.

How do you properly structure the investigator's brochure for clinical investigations according to MDR or performance studies according to IVDR?

• The structure should follow Annex XV MDR or the ‘Guidance on the Investigator's Brochure content’ (MDCG 2024-5) or Annex XIV IVDR.
• According to Annex XV MDR and Annex XIV IVDR, the instructions for use must be part of the manual. This is implemented either by making the entire instructions for use an appendix to the manual or by submitting the document separately and providing an exact reference (i.e. with the current name, version and date of the instructions for use) in the manual. If the instructions for use are changed, the corresponding information in the manual have to be updated as well.
• According to Annex XV MDR or Annex XIV IVDR, the list of compliance with the general safety and performance requirements must be part of the manual. This is implemented either by making the entire list an appendix to the manual or by submitting the document separately and providing an exact reference (i.e. with the current name, version and date of the instructions for use) in the manual. If this list is changed, the corresponding information in the manual have to be updated as well.
  
  Note: A mere list of standards is not sufficient for this purpose.

Common issues are:

• The investigational device is not described in detail in the application form/investigation plan/investigator's brochure (i.e. with the exact name, including model/version designations/numbers, if applicable for all components of which the investigational device consists).
• The investigation plan/performance study plan or the investigator's brochure do not contain the information required in Annex XV MDR/Annex XIII IVDR/Annex XIV IVDR.
• The investigator's brochure does not contain sufficient information on the risk classification.
• The intended purpose of the investigational device has not yet been determined or is not clearly described.
• The investigation plan/performance study plan does not include reporting requirements for SAEs or device deficiencies according to MDR or IVDR.
• The investigator's brochure lacks specific references to the instructions for use or the list of compliance with the general safety and performance requirements (i.e. name, version and date of the corresponding document).
• In the case of substantial modifications: the modifications are not identified in the respective document and/or are not justified.