Medical Device Directive – MDD

The Medical Devices Directives state that companies must do the following before they can place the CE Marking on a medical device:

• Compile a medical device CE Marking Technical File (or Design Dossier for Class III) with evidence of compliance to the Medical Devices Directive.
• 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.

Only after these CE Marking requirements are satisfied, you are allowed to affix the CE Marking on your medical device.

Padmira Consulting services for CE Marking of Medical Devices 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.