The MDR without jargon, in files you can read in five minutes and put into practice in an afternoon.
CE marking is not a quality seal. What the four-digit number means, why the class changes everything and the five checks article 14 of the MDR requires before you sell.
LabellingWhat each part of the unique device identifier means (UDI-DI and UDI-PI), which products must already carry it, and the three obligations distributors and pharmacies have under articles 14 and 27 of the MDR.
FILE DS-01 · PharmacyThermometers, blood pressure monitors, tests, wound care supplies: if they're on your counter, the MDR treats you as a distributor. What article 14 actually requires.
FILE DS-02 · InspectionThe short list for running a mock inspection this week: CE verification, language, importer, storage, complaints and traceability.
FILE DS-03 · ImportAuthorised representative, your name on the packaging, a filed copy of the declaration, and registering as an importer: what changes when your supplier isn't European.
FILE DS-04 · InspectionBefore the regional medical device inspection turns up, ask yourself its questions first. Half an hour, pen and paper — or the dashboard's mock-inspection mode.
FILE DS-05 · ProductPharmacies and orthopaedic shops across Spain buy from the same suppliers. Verifying them once and sharing that verification changes the economics of compliance.
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