MDR Compliance Consulting: From Gap Analysis to CE Marking
A clear view of where your device stands — and a roadmap for what is left before CE marking.
Scope
What’s Included
- Gap analysis against the requirements of MDR 2017/745
- Classification support (Annex VIII)
- General Safety and Performance Requirements (GSPR) checklist (Annex I)
- Regulatory strategy for your device and market
- Compliance roadmap with milestones
- Ongoing guidance as questions arise
Fit
Who It’s For
- Manufacturers preparing their entry into the EU market
- Legacy devices in transition to MDR 2017/745
- Manufacturers updating existing documentation
Deliverables
What You Receive
- Assessment report on your current compliance status
- Action plan with timelines
- Classification rationale document
- GSPR checklist for your device
Limits
What’s Not Included
- The conformity assessment itself — that is the Notified Body’s role, and no consultant can perform it or guarantee its outcome
- Drafting of the full technical file — see Technical Documentation
- Quality management system implementation — see ISO 13485 Implementation
Timing
Indicative Timelines
Typical duration: 4–8 weeks for gap analysis and roadmap, depending on portfolio size and documentation maturity. Ongoing guidance continues as long as you need it.
Ready to See Where You Stand?
Free initial consultation · Response within 24 hours · No obligation
Regulatory information last reviewed: 10 August 2026