Before you can sell a medical device or IVD within Europe, you must obtain CE Marking certification and place a CE Mark (CE Marking) on your product. The CE Marking for medical devices and IVDs is not a quality mark, nor is it intended for consumers. It is a legally binding statement by the manufacturer that their product has met all of the requirements of the Medical Devices Directive (MDD 93/42/EEC), In Vitro Diagnostic Device Directive (IVDD 98/79/EC) or the Active Implantable Medical Device Directive (AIMDD 90/385/EEC), where applicable. If a Notified Body is required, the Notified Body's four-digit number would appear below the CE Marking symbol.
CE Marking Checklist:
The Medical Devices Directives state that companies must do the following before they can place the CE Marking on a medical device or IVD:
- Compile a medical device 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 a medical device/IVD CE Mark certificate from a Notified Body if Class I with Measuring or Sterile function, Class IIa, IIb, or III, or if Annex II, List A; Annex II, List B, or self-testing IVD.
- Appoint a European Authorized Representative if you have no physical location in Europe.
- Register medical devices with the EU Competent Authorities, where applicable.
Only after these CE Marking requirements are satisfied are you allowed to place the CE Marking on your medical device.
Our CE Marking Services:
Emergo has assisted hundreds of companies with medical device CE Marking. Our services include:
- Medical Device and IVD 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.
- Authorized Representative for Europe.
Our quality management systems meet European CE Marking & other international requirements
Emergo can develop a compliant quality management system by applying ISO 13485 to ensure you meet the quality system requirements for Europe. Each system is customized for the manufacturer and can not only ensure compliance to the European Directives for Medical Devices (CE Marking), but also to the Canadian Medical Devices Regulations, United States FDA QSR, Australian TGA requirements, and Japanese Pharmaceutical Affairs Law.