The European Union (EU) Medical Devices Directive (93/42/EEC) mandates that all medical devices sold in the EU, irrespective of where they are manufactured, must have CE Marking affixed.
The CE Mark is not a quality mark, nor is it intended for consumers. It is a legally binding statement by the manufacturer that its product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVD 98/79/EC), or the Active Implantable Medical Device Directive (AIMD 90/385/EEC), where applicable.
The Medical Devices Directives require companies to satisfy the following requirements before they can apply the CE Mark to their medical device or IVD:
- Compile a CE Marking Technical File (or Design Dossier for Class III) with evidence of compliance to the Medical Devices Directive (or the IVD/AIMD Directives)
- Receive CE Certification from a Notified Body if Class I with Measuring or Sterile function, Class IIa, IIb, or III
- Appoint a European Authorized Representative if you have no physical location in Europe.
- Register medical devices with the Competent Authorities, where applicable
Oriel STAT A MATRIX can help you attain your CE Mark. Our support includes:
- CE Marking Technical File or Design Dossier compilation and review
- Verification of essential requirements
- Product classification and identification of applicable standards for medical devices
- Implementation and maintenance of ISO 13485 quality systems
- Product labeling and packaging review
- Risk assessment and management (ISO 14971)
- Development of Vigilance and Post Market Surveillance, including Vigilance Standard Operating Procedures and Processes
Contact us to learn more about CE Certification and FDA Compliance training and consulting. Request More Info or call 800.472.6477.