Scope and route
Defined product boundary, intended-purpose questions and the proposed MDR or IVDR route.
Paid route assessment · non-EU manufacturers
Know the EU route before you appoint an EC REP.
The EU Market Entry Readiness Review turns a short first conversation into a written decision: what your device needs, what is missing and which work should happen next.
A decision, not a free consultation
Get a written route and a controlled list of gaps.
MEDDEV reviews the information you provide, tests the proposed MDR or IVDR route and records the issues that would affect an EC REP mandate or EU market entry. The result is a defined next step, not a generic call summary.
01Device scope and MDR / IVDR route
02Classification assumption and evidence boundary
03Documentation, labelling and importer gaps
04EUDAMED, PMS and response-readiness dependencies
05Written outcome: ready, conditional or not ready
What you receive
A report your team can act on.
Within the agreed scope, MEDDEV provides the written findings and a 60-minute discussion of the route, open issues and recommended order of work.
Gap register
Evidence, labelling, importer, EUDAMED and post-market dependencies that need action.
Decision call
A 60-minute discussion with the written result and the next commercial scope.
Complex portfolios
Class IIb, Class III, complex IVD and multi-family portfolios receive a tailored fee after the first review of scope.
Applied to the next mandate
If MEDDEV accepts the EC REP mandate within 30 days after delivering the readiness report, EUR 500 of the review fee is credited against the first mandate invoice. The review fee is not a promise that a mandate will be accepted.
Discuss the review scope →