Germany: BfArM Recommendations for clinical trials with medical devices during the COVID-19 pandemic
On March 26, 2020, the BfArM published “Additional recommendations on the European Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic ” for clinical trials with medicinal products.
All recommendations are aimed at:
- continue to ensure the safety and well-being of the subjects,
- continue to ensure the suitability of the clinical trial to provide evidence of the safety, performance or effectiveness of the medical device and
- prevent an unnecessarily high load for the inspector and test center.
- Adjustments to the clinical trial for the COVID-19 pandemic
The sponsor of a clinical trial is responsible for the necessary adjustments to the clinical trial.
These changes to the clinical trial such as
- recruitment (suspension, extension)
- of times, scope and implementation of follow-up
- the user of the test products (professional application for own application) require a change in the protocol.
The modified protocol must be submitted to the competent higher federal authority and the responsible ethics committee as a change via DIMDI .
The test participants have to be informed about the changes and have to give their consent.
Furthermore, the sponsor has to check all quality assurance measures such as monitoring and auditing and to regulate them if necessary. All changes in quality assurance must be justified, documented and filed in the Trial Master File.
The BfArM guideline also covers:
- Notices of changes to ongoing clinical trials due to COVID-19
- Recommendations for performing remote monitoring
- Handling the investigational product
- Follow-up at home with test product, CE- marked medical device or without a product
- Other (Telemedicine, external service providers)
For BfArM’ communication in local language please visit this website.
Table of Contents
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Getting a CE mark for medical devices: a step-by-step guide
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A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
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FDA Breakthrough Device Acceleration
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
