How long does it typically take to obtain a CE marking under MDR or IVDR? Can consultants help speed up the process?

It can take 6 – 18 months, depending on product class and readiness. CE mark consultants can help speed up the process by identifying gaps early, aligning documentation to Notified Body expectations, and managing communications effectively.

How do CE marking consultants assist in meeting General Safety and Performance Requirements (GSPR)?

GSPR compliance involves technical documentation, risk analysis, and clinical evidence. EU MDR consultants ensure your product meets every applicable requirement by mapping each GSPR point with supporting documentation.

Is MDR/IVDR CE certification easier for legacy devices? What does the process involve?

Legacy devices must be re-evaluated under the new regulations. The process is not necessarily easier but may allow partial reuse of existing data. CE certification consultants assess what data is valid and identify what needs to be updated or generated anew.

Can data from MDD or IVDD be reused for MDR/IVDR compliance?

Yes, but only if the data meets current standards. Our CE mark consultant team evaluates legacy data and updates it where needed to align with MDR/IVDR requirements.

Do you offer turnkey CE marking consulting services?

Yes, Maven provides comprehensive support, from gap analysis to submission, so you can focus on innovation while we handle regulatory details. Our CE marking consultants are with you at every step.

How is the confidentiality and integrity of our data ensured during the CE marking process?

At Maven, we follow strict data protection protocols and sign confidentiality agreements. Your technical files, clinical data, and sensitive business information are handled securely throughout the process.