The MDR without jargon, in files you can read in five minutes and put into practice in an afternoon.
Thermometers, 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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