CE Approval vs. CE Mark for EU Directives
Clients often inquire about the process for achieving CE approval of a medical device. The word CE 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 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).
CE Mark Requirements for CE Compliance Based on Risk
The CE Mark requirements for medical device products are based on risk. For products with minimal risk, self-certification may be an option for determining CE compliance, 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” to ensure CE Compliance. Notified bodies are private organizations or government agencies that serve as independent test laboratories and perform the steps identified in the relevant Medical Device Directives. Manufacturers may choose a Notified Body in any member state of the European Union.
Aptiv Solutions will work with you to identify the CE mark requirements for your particular medical device, product, or system and complete the following steps to help you to comply with CE mark requirements:
- 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 the required Technical File or Design Dossier
- Confirm product classification and identify applicable Harmonized Standards to demonstrate ‘presumption of conformity’
- Design, implement and maintain an ISO 13485 quality systems
- Review product labeling and packaging
- Perform risk assessment and management to meet ISO 14971, Risk Assessment requirements
- 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 requirements, ISO 14155, and country specific regulations
- Serving as your EU 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
- Conduct audits of quality systems to ISO 13485 and US FDA requirements, and provide support during official regulatory audits
Contact us for assistance to obtain the CE mark for your medical device.
