GHMAP
EU MDR market-access overview for class i devices. Planning intelligence only — not a regulatory determination, approval, or clinical decision support.
Planning ranges for this country and device class. Label every figure as illustrative until sources are verified.
| Metric | Value | Status |
|---|---|---|
| Authority | EU MDR Notified Body / Competent Authorities | Source tracked |
| Device class | Class I | Example only |
| Average timeline | ~120 days / ~4 months (illustrative) | To be verified |
| Local representative required | Yes — European Authorized Representative (if non-EU manufacturer) | To be verified |
| Government / assessment fee | ~$5,000 USD (illustrative) | Source required |
Step-by-step planning outline. Owners and sequence vary by product evidence and authority questions.
Document the Class I rationale against EU MDR classification rules before dossier work begins.
Owner: Manufacturer
Engage the local role required for foreign manufacturers where applicable, and confirm who holds the regulatory file.
Owner: Manufacturer
Compile quality-system evidence, labeling, performance/clinical summaries, and any prior approvals the authority accepts as supporting material.
Owner: Manufacturer
File through the required channel, pay applicable fees, and track deficiency questions that stop the review clock.
Owner: Local representative / Manufacturer
Respond to authority questions, obtain listing/clearance when issued, and maintain post-market and renewal controls.
Owner: Local representative / Manufacturer
Cross-links between pathway pages, country intelligence, and certification primers.
Broader market, reimbursement, and procurement context for European Union.
Open country profilePublic pathway pages are general context. Product-specific decisions use request-first market entry packages with written scope lock before research begins.
$5,000 · 15 business days after complete intake and scope lock
Product-specific market-entry decision for one healthcare or MedTech product in one target country. Includes the Decision Report, Evidence & Calculations Workbook, a 60-minute analyst debrief, and one consolidated revision round.
$7,500 · 20 business days after complete intake and scope lock
Evidence-based distributor search for one defined MedTech or IVD product in one selected country: 10–15 screened candidates, 10 detailed assessments, and 3–5 recommended for outreach when evidence supports it.
Prefer a shorter briefing first? Request a Regulatory Pathway Brief ($1,800).
Market entry packages
GHMAP confirms written scope before Country Intelligence or Distributor Search research begins. Payment never auto-approves introductions or workspace access.
Professional review remains part of every GHMAP deliverable.
