CE Mark Consultants & CE Marking for Medical Devices

A CE mark must been placed on your product before you can sell a medical device or IVD within Europe. The CE Mark for medical devices is not intended for consumers nor a quality mark. 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.

Before companies can place the CE marking on a medical device or IVD, the Medical Devices Directives state that companies must do the following :

• 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 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.

You are allowed to place the CE Marking on your medical device, only after these CE Marking requirements are satisfied.

Bielderman has assisted companies all over Europe with medical device CE Marking. 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 are conform with European, US, Canadian, Japanese PAL and Australian requirements.

Bielderman can ensure you meet the quality system requirements for Europe by developing a compliant quality management system by applying ISO 13485:2003. Each system is customized for the manufacturer. Furthermore Bielderman 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.