The MDR without jargon, in files you can read in five minutes and put into practice in an afternoon.
When a medical device causes harm, not everyone has the same obligation to report it. We explain what a serious incident is, the manufacturer's deadlines, and what the distributor must do.
ProductYou sell medical devices under your own brand and wonder if that makes you a manufacturer. The MDR has the answer, and it's not always the one you expect.
InspectionMDR article 14.3 requires the distributor to store the product according to the manufacturer's conditions. Here's what this means in practice and which date takes precedence.
ProductWhen the manufacturer notifies you of a safety corrective action, the distributor has specific obligations. Here is what each party is responsible for, what records you need, and what does not fall under your remit.
ProductClass I, IIa, IIb or III: who decides the class of a medical device, why it appears in the supplier's documentation, and what obligations it generates for the seller.
CE markingCE 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.
Take the inspector's test: the real questions of an inspection visit, two minutes, instant result. Nobody else sees your answers.
Take the free test