Pharmacie Kennedy Mulhouse

A medical device marked CE: what should you check before using it?

CE concerns a medical device’s conformity. Its intended use, suitability for your needs and reimbursement require separate checks.

Editorial illustration of a health discussion; it does not depict the pharmacy’s actual premises.
Editorial illustration — Kennedy Pharmacy Mulhouse

General information, not an individual diagnosis. Ask a healthcare professional if you are unsure about your situation.

A thermometer, dressing or orthosis can be a medical device. Its manufacturer assigns it a particular medical purpose. Before using the product, identify its exact name and the intended use described in its instructions.

CE marking on a medical device indicates conformity with the applicable general safety and performance requirements. This regulatory marking does not, by itself, establish that the device suits a particular person’s needs.

Reimbursement is a separate stage. France’s HAS assesses certain devices after CE marking for admission to or continued reimbursement. It explains that CNEDiMTS does not assess every device individually; CE is not a reimbursement guarantee.

Show the equipment’s name and instructions to the appropriate professional. Ask about its intended use and the characteristics relevant to the need discussed. This conversation can help you avoid choosing based solely on the logo.

Check that you have the instructions and ask about the necessary accessories, upkeep and maintenance. The DGCCRF also recommends asking about prices, warranties and reimbursement conditions before an intended purchase.

Keep the documentation for the relevant model and the answers you receive. If an instruction or intended use remains unclear, have it clarified before acting. This article does not select equipment for you or confirm reimbursement or an implant’s MRI compatibility.

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