European CE Marking Strategy for Medical Devices
ANSWERED ON THIS PAGE:
What is the EU CE Mark and what does it mean?
What is the medical device CE Marking process for Europe?
Who is responsible for maintaining regulatory compliance in Europe?
To sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates that your medical device complies with the applicable EU regulations and enables the commercialization of your products in 32 European countries. As a legal medical device manufacturer, you are responsible for maintaining regulatory compliance and securing CE marking for your product, regardless of whether you outsource any or all components of your manufacturing operation. IVD? See next page.
How to obtain European CE marking for your medical device
CE is not a quality mark, but to comply with the EU directive, you must meet specific standards in terms of performance, quality, safety and efficacy of the product type. We have a detailed process here, explaining the current European medical equipment CE approval process, you need to contact us. However, the basic process follows these steps:
Determine which EU Directive applies to your device: Medical Devices Directive (93/42/EEC), In Vitro Diagnostic Devices Directive (98/79/EC), or Active Implantable Medical Devices Directive (90/385/EEC).
Determine the classification of your device.（contact us）
Implement a Quality Management System, if applicable to your device.
Prepare a CE Marking Technical File or a Design Dossier.
Prepare a Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 rev4 and MDD (or MDR).
Select and appoint a European Authorized Representative to act on your behalf within the EU if you have no physical location in Europe.
Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless your device is Class I, is not sterile, and has no measuring function.
Obtain CE Marking and ISO 13485 certificates from your Notified Body.
Prepare a Declaration of Conformity (DoC), which states that your device complies with the appropriate Directive.
NOTE: The medical device CE Marking process will change when Europe’s new Medical Device Regulation (MDR 2017/745) comes into force in May 2021. Contact us to help you solve the related process
Medright tech Inc. can help you obtain EU CE Marking for your medical device
Medright tech Inc. has a well-established， We have assisted hundreds of medical device manufacturers with CE compliance for Europe. 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 13485) that will meet European and other international requirements
Authorized Representative services in Europe
Risk assessment and management (ISO 14971)
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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