Streamlining Your CE Marking Process: Tips for Efficiency and Success
Introduction The CE marking is a mandatory conformity marking for products sold in the European Economic Area, demonstrating compliance with applicable EU directives and regulations. It ensures that medical devices meet essential safety, performance, and quality requirements for market entry in the EU. What...
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Introduction For manufacturers of in vitro diagnostic (IVD) devices seeking to market their products in the European Union, ensuring MDR compliance is a critical requirement. The EU Medical Device Regulation (MDR) has...
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The Significance of Thorough Documentation for MDR ComplianceIntroductionKey Elements of Technical Documentation for MDR ComplianceMDR Compliance: A Documentation-Driven ProcessThe Advantages of Comprehensive DocumentationConclusionReferences Introduction On 26 May 2017, the Medical Device Regulation...
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Introduction In today's globalised marketplace, manufacturers seeking to enter the European Union (EU) market must navigate a complex regulatory landscape. One of the most crucial requirements is obtaining the esteemed CE Marking...
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The Evolving Regulatory Landscape The Medical Device Regulation (MDR) (Regulation (EU) 2017/745) came into full effect in May 2021, replacing the previous Medical Devices Directive (MDD). The MDR introduces stricter requirements than...
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Understanding the Regulatory Landscape The EU regulatory landscape for medical devices is dynamic and constantly evolving. Consultants must stay current with the latest regulations, including amendments and interpretations. Key aspects to grasp...
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Understanding CE Marking CE stands for Conformité Européenne, which translates from French to "European Conformity". It's a marking that signifies a product's compliance with various safety, health, and environmental protection standards set...
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What is CE Marking? CE stands for "Conformité Européenne," which is the French term for European conformance. All 27 EU members, as well as Iceland, Norway, and Liechtenstein, must have the mark...
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Post-Market Surveillance (PMS) is a regulatory requirement. It is mandatory in global markets including the United States and European Union. PMS comprises of activities that relies on data gathering. It helps collect...