- What regulatory requirements apply to your medical device?
- How long does the process of obtaining CE marking take?
- What costs can you expect?
A reliable answer is only possible once the fundamental aspects of a conformity assessment have been clarified. VDE Health’s CE Roadmap provides a structured basis for decision-making in this regard.
What is the CE Roadmap?
The CE Roadmap is a structured analysis and planning process. It clearly outlines the regulatory path to CE marking for manufacturers and links the requirements profile to a breakdown of costs, potential processing times and specific recommendations on how to proceed.
Your outcome
Upon completion of the CE Roadmap, you will receive a well-founded assessment:
- 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 likely to be required,
- what costs, risks and timeframes should realistically be factored in,
- which next steps should be prioritised.
The 5-step process
How to create your CE roadmap
- Clarify the project status
Joint workshop on the product, project status and information requirements. - Carry out a gap analysis
Compare the current status with the target requirements, particularly regarding intended use, qualification, risk class, processes and documentation. - Draw up the roadmap
Description of the regulatory pathway leading to CE marking. - Prepare a report
Document the results in a structured report. - Prepare for implementation
Workshop on implementation steps, risks and recommendations for the way forward.
Your benefits
- Early clarity on regulatory requirements
- A more realistic assessment of time, costs and resources
- Avoiding costly missteps
- Better preparation for Notified Bodies and regulatory requirements
- A more sound basis for decision-making regarding development, financing and market access
- Specific recommendations for the next implementation steps
Are you planning a medical device and would like to assess the regulatory burden?
VDE Health supports you in planning the path to CE marking in a structured way – from the intended purpose right through to implementation planning.
