This blog aims to unpick, debunk and clarify some of these misconceptions, starting with the basics. The CE Marking serves as a declaration from the manufacturer that their product complies with the essential requirements of the relevant European health, safety and environmental legislation laid out in the different product directives.
It also means that customs and other enforcement authorities are permitted to withdraw non-conforming products. The process of establishing whether or not a product requires the CE Marking is somewhat complex. Manufacturers need to establish:. Any organization manufacturing or selling products in the EU should be aware of its obligations when it comes to demonstrating conformity to requirements and directives:. Cart Total: Checkout. Learn About Quality. Magazines and Journals search. CE Marking Resources.
Articles Case Studies Jobs. CE Marking Related Topics. What is CE Marking? How does the CE Mark Work? CE Mark Certification Vs. What is the medical device CE Marking process for Europe?
Who is responsible for maintaining regulatory compliance in Europe? How to obtain European CE marking for your medical device CE is not a quality mark, but compliance with EU Directives requires you to meet specific standards of performance, quality, safety, and efficacy for your product type. Determine the classification of your device.
See our chart. Implement a Quality Management System , if applicable to your device. Most companies use ISO to meet the requirements. Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe. Prepare a Declaration of Conformity DoC , which states that your device complies with the appropriate Directive.
Preparing a complete EU Technical File is now faster and easier. Our services include: Assistance with product classification Verification of applicable standards and testing requirements Technical File or Design Dossier compilation, or review of your files Review of existing marketing materials, labeling, and user manual information to ensure compliance and consistency Verification of compliance with Essential Requirements Preparation of Clinical Evaluation Report based on provided clinical data Implementation, modification, and maintenance of a quality system usually ISO that will meet European and other international requirements Authorized Representative services in Europe Risk assessment and management ISO Development of vigilance and post-market surveillance procedures Contact us to learn how we can help you obtain CE marking for your medical device in Europe.
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