Roadmap: How to place medical device on the EU market

Bringing a medical device to the European market involves more than adding a CE mark to the product.

The process starts with the basics:

1. Define the intended purpose Confirm that the product qualifies as a medical device.

2. Determine the MDR classification The classification defines the regulatory route, the required evidence and whether a Notified Body must be involved.

3. Prepare the technical documentation This includes risk management, clinical evaluation and post market surveillance.

4. Appoint an EU Authorised Representative This is mandatory for manufacturers established outside the EU.

5. Complete the conformity assessment Issue the EU Declaration of Conformity and apply the CE mark.

6. Prepare the device for the market Assign the UDI and finalise the labelling and instructions for use.

7. Complete the registrations Register the company and device data in EUDAMED and check the national requirements of each target market.

The CE mark is not the first step.

It is the result of a complete and compliant regulatory process:

MDR roadmap EU market for medical devices