Regulatory & Business Consultancy
European CE Marking for Medical Devices
In order to be able to sell medical devices in the European Union (EU), you must obtain or apply CE Marking for your product. CE Marking indicates a product’s compliance 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.
How to obtain 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. 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.
- Implement a Quality Management System, if applicable to your device. Most companies use ISO 13485 to meet the requirements.
- Prepare a CE Marking Technical File or a Design Dossier
- 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.
Our services include:
- Assistance with product classification
- Verify applicable standards and testing requirements
- Technical File or Design Dossier compilation, or review of your files
- Review 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