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
Latest Articles
Practical 510(k) vs PMA vs De Novo FDA Pathway Guide
Practical 510(k) vs PMA vs De Novo guidance for choosing an FDA device pathway based on classification, predicates, risk, and evidence needs
Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
This article provides general information and does not constitute regulatory, legal, clinical, or compliance advice. Requirements and appropriate processes may vary by study, product, jurisdiction, and organization. Medigen Suite functionality should be used in accordance with applicable regulations, study documentation, and internal procedures.
