Operator-grade guides on EU MDR, IVDR, country-specific regulatory frameworks, hospital procurement, and distributor selection — written by someone who has actually run European MedTech distribution operations.
What the CER actually requires, how MDR Article 61 changed the equivalence pathway, what Notified Bodies look for, and the rejection drivers to avoid. Class-by-class breakdown plus realistic timeline and cost.
EU MDRThe Article 11 EC REP role explained — joint liability, selection criteria, contractual structure, distributor-as-EC-REP trade-offs, Switzerland CH-REP and UK Responsible Person.
EU MDRThe four PMS documents (PMS Plan, PMSR, PSUR, PMCF), data flow design, vigilance vs. PMS distinction, audit findings to avoid. From PSUR cadence to operational reality.