MDCI: Guiding Innovation

Home > Services > Regulatory > EU Directives / CE Mark

EU Directives / CE Mark

Clients often inquire about how MDCI can assist with CE approval. The word approval is a bit misleading, as the CE mark is not truly an “approval” to market your medical device. Rather, it is a symbol affixed to your product labeling to to indicate that it does in fact meet the requirements of the applicable European Medical Device Directive(s), (i.e., Active Implantable Medical Device Directive 90/385/EEC and the Medical Device Directive 93/42/EEC as modified by Directive 2007/47/EU, or the In Vitro Diagnostic Medical Device Directive 98/79/EC).

For products with minimal risk, self-certification may be an option, where the manufacturer prepares a Declaration of Conformity and affixes the CE Mark to their own product.

For products with greater risk, manufacturers may require independent certification by a "Notified Body". Notified bodies are private organizations or government agencies that serve as independent test laboratories and can perform the steps identified in the relevant Medical Device Directives. Manufacturers may choose a Notified Body in any member state of the European Union.

MDCI will work with you to identify the CE mark requirements for your particular medical device, product, or system and help you to:

• Verify the Essential Requirements for your device
• Choose the most appropriate Conformity Assessment Route
• Identify an optimal Notified Body to meet your specific needs, if necessary
• Review and update your existing Technical Documentation
• Compile your Technical File or Design Dossier
• Confirm product classification and identify applicable Harmonized Standards to demonstrate 'presumption of conformity'
• Design, implement and maintain ISO 13485 quality systems
• Review your product labeling and packaging
• Perform risk assessment and management to meet ISO 14971, Risk Assessment
• Develop Vigilance Procedures and Postmarket Surveillance
• Undertake national notifications and registrations
• Manage and monitor your EU-based medical device clinical trials in conformance with applicable U.S. FDA, ISO 14155, and country specific regulations
• Serve as your Authorized Representative, if you have no registered office in the European Union
• Prepare and provide on-site training for all aspects of compliance with the Directives
• Carry out audits of quality systems to ISO 13485 and US FDA requirements, or provide support during official regulatory audits

Click here to learn more about obtaining the CE mark for your medical device.