CE Mark Consultants for Medical Device and IVD Companies
Before you can sell a medical device or IVD within Europe, you must place a CE Mark (CE Marking) on your product. The CE Mark 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 (IVD 98/79/EC) or the Active Implantable Medical Device Directive (AIMD 90/385/EEC), where applicable.
See a diagram of the CE Mark approval process for medical devices
See a map of Europe showing countries where CE Marking is required
The Medical Devices Directives state that companies must do the following 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 a CE Mark certificate 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 EU Competent Authorities, where applicable.
Only after these CE compliance requirements are satisfied, are you allowed to place the CE Mark on your device.
Emergo Group has assisted hundreds of medical device companies with CE Mark approvals. Our services include:
- 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 can meet European, US, Canadian, Japanese PAL and Australian requirements.
Emergo Group can develop a compliant quality management system by applying ISO 13485:2003 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 Mark), but also to the Canadian Medical Devices Regulations, United States FDA QSR, Australian TGA requirements, and Japanese Pharmaceutical Affairs Law.
Please contact us for a free consultation on how our CE Mark consultants can help to obtain CE approval for your medical device or IVD in Europe.
