CE Roadmap

• What regulatory requirements need to be considered?
• How long can the process of obtaining CE marking take?
• What costs should be expected?

A well-founded assessment is only possible if the fundamental aspects of a conformity assessment are properly understood from a technical perspective. The CE Roadmap provides a basis for decision-making in this regard.
 

What is the CE Roadmap?

The CE Roadmap is a technical and regulatory analysis and planning process. It transparently outlines a potential regulatory path to CE marking for manufacturers and links the identified requirements profile to a plan that includes costs, estimated processing times, and specific recommendations for next steps.
 

Result

After completion of the CE Roadmap, a well-founded technical and regulatory assessment is available:

• which regulatory requirements are relevant to your product,
• which documents, evidence, and processes are required,
• whether and when a Notified Body must be involved,
• which conformity assessment procedure is applicable,
• what efforts, risks, and timeframes should realistically be planned for,
• and which next steps can be prioritized.

Procedure

1. Clarify the project status
   Joint workshop on the product, project status, and information needs.
2. Conduct a gap analysis
   Analysis of the current state of preparation and identification of necessary actions, particularly regarding intended use, qualification, risk class, processes, and documentation.
3. Develop a roadmap
   Description of a possible regulatory path leading to CE marking.
4. Prepare a report
   Document the results in a structured report.
5. Prepare for implementation
   Workshop on implementation steps, challenges, and recommendations for the next steps.

Benefits

• Early guidance on regulatory requirements
• More realistic assessment of time, costs, and resources
• Early detection of potential missteps
• Better preparation for Notified Bodies and regulatory requirements
• More informed basis for decision-making regarding development, financing, and market access
• Concrete recommendations for the next implementation steps

Do you have any questions?

Please note: This description is intended solely to provide general information about the range of services offered by VDE Health. It does not constitute a binding offer. The nature, scope and specific details of the services will be agreed upon jointly on a case-by-case basis and set out in a separate agreement.