Question 1

How long does it take to launch a medical device in Europe?

Accepted Answer

Total time from today to first invoiced sale typically ranges from 3 months (CE-marked Class I, distributor-led, single country) to 36+ months (Class III, starting from prototype, multi-country direct sales). For a typical Class IIa device with CE under MDR already in place, expect 6-9 months to first sale via distributor; 12-18 months via direct sales build-out. The calculator computes a realistic timeline based on your specific class, MDR status, target countries, and GTM model.

Question 2

What is the EU MDR transition timeline?

Accepted Answer

Legacy MDD-certified devices have transition deadlines into 2027-2028 depending on class. Notified body capacity is constrained — engaging early and running QMS build in parallel with technical file development typically saves 6-9 months versus serial workflow. New CE certification for non-EU manufacturers typically takes 9-18 months from QMS-ready to certificate.

Question 3

Do I need an EU Authorized Representative?

Accepted Answer

Yes — under EU MDR Article 11, any non-EU manufacturer must appoint an EU Authorized Representative (EC REP) before placing devices on the EU market. The EC REP has joint regulatory liability with you. Switzerland additionally requires a separate CH-REP, and the UK requires a UK Responsible Person. Allow 1-3 months for selection, due diligence, and contract negotiation.

Question 4

How much does CE marking cost for medical devices?

Accepted Answer

Notified body fees range from €15,000 for a simple Class IIa device to €150,000+ for a Class III implant with full design dossier review. Add ~€20,000-€80,000 for clinical evaluation work depending on equivalence pathway, plus annual EC REP fees of €5,000-€20,000 and post-market surveillance system costs.

Question 5

Which European country should a medical device launch first?

Accepted Answer

Germany is the most common Tier 1 launch market — largest EU MedTech market (~€34B), efficient BfArM registration (no separate national notification on top of CE), strong distributor density. UK requires separate UKCA + MHRA registration. France requires ANSM notification and LPP reimbursement work. Italy requires Repertorio dei Dispositivi Medici notification. Switzerland requires CH-REP. The calculator factors these per-country delays into your timeline.

Question 6

Distributor or direct sales for European medical device launch?

Accepted Answer

Distributor-led launches typically reach first invoice in 5-8 months after CE-ready; direct sales in 9-12 months. Distributors trade margin (typically 25-45%) and brand control for speed and capital efficiency. Direct sales preserve margin and customer relationships but require country teams, payroll entities, and localized infrastructure per market. Hybrid models are common: direct in 1-2 lead markets, distributors elsewhere.

How long until your first European sale?

What's your EU MDR risk class?

What's your current CE / MDR status?

Have you appointed an EU Authorized Representative?

Which target countries first?

What's your go-to-market model?

Your realistic path to first EU sale

Month-by-month Gantt

Key milestones

Risk flags

Need help executing this timeline?