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Introduction to Clinical Evaluation Reports (CER) for Europe
Whether you're a small device manufacturer struggling to market your first product, or a multinational working on the 8th generation of your device,
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Watch our recent webinar on the European In Vitro Diagnostic Devices Regulation
WATCH NOW: Europe's New IVDR 2017/746
Within the next few years, the regulatory landscape will change dramatically for IVD companies selling in Europe. The current In Vitro Diagnostic
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Implementing a Medical Device Post-Market Surveillance Program
How do you make sure your device remains safe and effective once it’s on the market? It’s called medical post-market surveillance (PMS), a system
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MDR and Combination Products
Combination products, usability, and the EU MDR
The European Medicines Agency (EMA) has recently issued draft guidance on Drug Device Combinations (DDC) that calls for usability studies, to come
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ISO 13485:2016 and the new Risk-based Approach
The new ISO 13485:2016 quality management system standard for medical devices introduces lots of new changes and concepts. However, its emphasis on
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Learn about the European Directives and Regulations which apply to medical devices
Medical Device Regulations in Europe
All regulatory documents shown below were published by the European Parliament or European Commission. Please help us maintain this list by reporting
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SPAIN – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and healthcare market data on Spain, plus specific information about the medical device and healthcare
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Sweden – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and economic data for Sweden, plus specific information about the country's medical device and healthcare
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