Switzerland: New requirements and changes to authorization practice as of May 2021
Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials in Switzerland.
Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals and local Ethics Committees. Please feel free to contact us for advice on the new requirements on clinical trial authorization in Switzerland.
Key changes:
- Starting May 1, 2021: submissions (including any subsequent submissions) must be sent on the same day both to Swissmedic and to the responsible cantonal ethics committee
- Starting May 1, 2021: new applications forms and extended folder structure for submissions
- Starting May 5, 2021: Requirements set forth in Annex 1 of Regulation (EU) 2017/745 (MDR) will begin to apply to investigational devices without CE mark
- Starting May 5, 2021: SAE reporting will be made on a new form, in accordance with with MDCG 2020-10.
For detailed information, please see the official communication from Swissmedic.
Contact Meditrial for immediate assistance in Europe or the US.
Table of Contents
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Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
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
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, but modes have changed, as has the role that associations and patients themselves take on [...]
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.
