Medical device & MDR

How to check whether a scooter is a medical device

How to check whether a scooter is a medical device

In brief

To check whether a scooter is a medical device, look at the manufacturer's EU declaration of conformity, the label with the CE marking and MD symbol, the instructions for use stating the intended purpose and, where available, its registration in the European EUDAMED database.

1. Ask for the EU declaration of conformity

This is the document in which the manufacturer declares that the product complies with Regulation (EU) 2017/745 and states its class.

2. Check the label

Look for the CE marking, the "MD" (Medical Device) symbol, the manufacturer's details and the UDI identifier where applicable.

3. Read the intended purpose

In the instructions for use, the manufacturer describes what the product is for.

4. Consult EUDAMED

The European database of medical devices lets you look up information on operators and devices, within the limits of the modules currently active.

Beware of vague claims

Phrases such as "medically certified" or "approved" with no documents behind them are not enough. Always ask for the paperwork.

Frequently asked questions

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