Register Medical Devices

Services guide...

CE MARK AND ACCESS TO THE MARKET

process

• 1. The product compliance must be ensured
• 2. The product must be classified
• 3. Technical File elaboration.
  • Essential requirements.
  • Processes Validation.
  • Clinic Evaluation.
  • Laboratory test verification.
  • Risk management.
• 3. A Notified Body must be involved (for products other than class I) and the technical file including the Declaration of Conformity must be prepared.
• 4. The CE mark must be affixed and labeling has been completed.

• 5. European Representative.

• 6. Bio-Vigilance ^® system.
  • Solutions in medical devices vigilance after the placing on the market.