Overview in MDR Article 82 Context Interventional clinical investigations of non–CE-marked MRI and MR spectroscopy devices (e.g. novel RF coils, pulse sequences) are governed by the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745). Specifically, if these trials are not undertaken to support CE-marking of the device (i.e. they are “other” clinical investigations under MDR… Continue reading Competent Agencies for Medical Device Trials in EU-Memberstates
Category: Legal Background
In this category posts on the legal situation in ClinO-MD of Switzerland and the EU-MDR are located.
Regulatory Requirements for MRI/MRS Device Trials in the EU and Switzerland
Introduction Interventional MRI/MRS device trials – such as studies involving MRI-guided interventions or devices used within an MRI scanner – must navigate complex regulatory frameworks to ensure patient safety and compliance. In the European Union, these trials are governed by the EU Medical Device Regulation (MDR 2017/745) and relevant national laws. These rules outline how… Continue reading Regulatory Requirements for MRI/MRS Device Trials in the EU and Switzerland
Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
Switzerland’s regulatory framework for clinical investigations with medical devices, including investigational devices like experimental MR-pulse sequences and non-CE-marked RF coils, is governed by the Ordinance on Clinical Trials with Medical Devices (ClinO-MD). This aligns with the Swiss Human Research Act (HRA) and is influenced by the European Union’s Medical Device Regulation (EU-MDR) to ensure harmonized… Continue reading Research on Investigational Medical Devices in Switzerland: Legal Insights and EU-MDR Context
Background of this Blog: Personal Experience
Thirty years ago, the landscape of MRI research and clinical trials was a very different world compared to the complex regulatory environment we navigate today. Back then, conducting an MR study required little a few A4 page sized proposal submitted to the local ethics committee here in Bern. It was a time when innovation flourished… Continue reading Background of this Blog: Personal Experience
The Importance of a Monitoring Plan in MR Medical Device Studies
You need to be logged in to view this content. Please Log In. Not a Member? Join Us
Revision of Human Research in Switzerland — The Revised HRA Ordinances
Switzerland has taken a significant step forward in regulating human research with the revision of the Human Research Act (HRA) ordinances. Approved by the Federal Council, the updated ordinances, designed to reflect advancements in digitalization, national and international standards, and research practices, officially came into effect on 1 November 2024. However, provisions on transparency will… Continue reading Revision of Human Research in Switzerland — The Revised HRA Ordinances
You must be logged in to post a comment.