This section provides relevant news on the (European) regulatory environment for medical devices. You may browse the articles by the following overview of the 10 latest topics or by selecting your topic of interest in the keyword section further below. The news and articles published on this website are presented in a condensed form. You may access our full-scale service when engaging mdi Europa as your EU Authorized Representative.
Browse our “News in Brief” section by 10 newest articles
- New Notified Bodies Designated under the MDR and IVDR
- News from the Commission – Notified Bodies and a Potential MDR Extension for Selected Devices
- European Commission Website on Regulations MDR / IVDR Restructured
- New Checklist for Clinical Evaluations Available
- New Vigilance Reporting Templates and Supplementary Guidance on Vigilance Published
- BfArM Informs about Insufficient Labeling of Speaking Valves
- Recommendation of BfArM regarding Breathing Hoses in Anesthesia
- Most Important Changes – Regulation (EU) 2017/745 on Medical Devices (MDR)
- Most Important Changes – Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR)
- Guidance on Person Responsible for Regulatory Compliance
Browse our complete range of articles by keyword
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