Many sponsors preparing clinical investigations under MDR encounter a similar concern when planning submissions in Germany: unpredictable timelines and extensive questions from both the Ethics Committee (EC) and the Competent Authority (CA, especially from the Federal Institute for Drugs and Medical Devices (BfArM)).
Germany is widely perceived as one of the most demanding regulatory environments in Europe. Sponsors often report that requests for clarification are detailed, iterative, and sometimes difficult to anticipate. This can lead to delays, increased costs, and internal uncertainty. However, is not that Germany is “difficult” per se. The EC and CA are expecting a high level of clarity, consistency, and risk justification from the start and study documentation that is complete, clear and consistent.
From a sponsor’s perspective, success in Germany starts long before submission. The key is to approach the process as a structured risk-communication exercise, not just a documentation exercise.
Be aware that submission to the Central Ethics Committee (CEC = the EC responsible for the Coordinating Investigator in Germany) and the Competent Authority is done at the same time. The submission package is the same. So, ALL documents must be ready at the time of submission.
Be aware that if you intend to perform imaging that uses radiation and the imaging is not Standard of Care, an application or notification to the Federal Office for Radiation Protection (BfS) is required as well. The dossier includes a lot of forms. The completion of the forms is time consuming. This BfS dossier must be uploaded in the same electronic portal than the EC and CA package and will be reviewed by the BfS only. So, also this package must be ready at the time of the overall submission. That is why a careful planning on what is needed and until when is critical.
1. Align clinical and regulatory narratives early
Ensure that the Clinical Investigation Plan, risk management file, and Investigator’s Brochure tell the same story. Misalignment between documents is one of the most common triggers for questions.
2. Ensure documents contain all information that is required
The MDR describes the content of specific documents and there are several MDCG guidance documents available that provide detailed information on the content of these documents. Adhere to guidance documents and use checklists to ensure that you did not forget anything.
The ECs and CA in Germany are strictly checking if the MDR has been followed. Any gap will usually result in a finding right away during the validation review phase of the submission dossier. Be aware that you have only limited time (10 days) to revise documents during the validation phase. Gaps in the documents that require resolution will lead to unnecessary stress and pressure on all sides.
3. Ensure involvement of external partners is well explained
If you involve external partners (central laboratories for imaging for example, or committees that decide about patient eligibility etc.), ensure that their involvement is well explained in the study documents (who are they, what do they do, how to they do that, how is the decision documented and communicated).
4. Anticipate risk-based scrutiny
Germany expects strong justification of benefit–risk, particularly for first-in-human (FIH) or novel technologies. A proactive justification of endpoints, safety monitoring, and stopping rules reduces back-and-forth. If you have a FIH or novel technologies, think about a stepwise inclusion/treatment of patients to see if any safety issue occurs (e.g. treatment of patient 1 followed by a follow-up for xx days, if no issues, treatment of patient 2 etc. / if no issues after a certain amount of patients, then this approach can be stopped). Consider having a DSMB and a Clinical Event Committee if you have a FIH or novel technology.
5. Invest in language and clarity
Even though submissions are in English, reviewers appreciate clear, structured writing. Avoid overly promotional or ambiguous wording. If your documents are unclear, overly complex, or inconsistent, this increases perceived risk. As a result, they ask more questions. Clear language reduces uncertainty fewer questions.
6. Prepare for Ethics Committee (EC) submission
The EC will typically concentrate on patient protection, consent, recruitment, and burden. A well-designed patient information and consent form (ICF) is critical. In Germany there are ICF templates available. Use of the correct template is a must and will reduce the number of questions or change requests by the EC. Think about other patient material (questionnaires, implant cards, recruitment material etc.)
7. Site Specific Documentation
There are plenty of site-specific documents required for the submission. Each participating investigator must be known, and corresponding documents must be submitted. Therefore, it is important that the site selection process is finished or almost finished when the regulatory submission preparation starts.
With a structured approach, sponsors often see:
Most importantly, the process becomes more manageable and transparent.
If you plan a submission in Germany, focus on these priorities:
Feel free to contact us if you have any more questions. Our team is ready to support you.