Also called: MDR · Regulation (EU) 2017/745 · CE mark
Under the EU Medical Device Regulation (EU) 2017/745 (MDR), a medical device may be placed on the EU market only with CE marking. The manufacturer classifies the device (classes I, IIa, IIb and III, by risk), completes the conformity assessment — with a notified body for most classes above I — and issues an EU declaration of conformity. Türkiye applies the same rules through its own medical device regulation, harmonised with the MDR.
For buyers, the practical points are: which items in a kit are medical devices, which ones need CE marking in the destination country, and which documents (declaration of conformity, instructions for use in the required language, labelling) must accompany them. These documents come from the device manufacturer; a supplier cannot replace them.
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