A startup based in the United States, in Asia or in any other non-EU country that wants to market a medical device in Europe faces a complete regulatory pathway. The order in which it undertakes its actions often determines the duration and the total cost of the process.
The optimal sequence for a non-EU startup
Step 1: confirm MDR qualification and classification. Before any investment in the European regulatory process, confirm that the product is indeed a medical device within the meaning of Article 2(1) of the MDR and determine its class. This step takes 2 to 4 weeks and shapes everything that follows.
Step 2: assess the available clinical data. To access the European market, substantial clinical data are required, particularly for class IIa and above. If the data exist (studies conducted in the United States, in Asia or elsewhere), assess their acceptability in the MDR context. Studies conducted in accordance with ICH GCP and FDA data may be usable, but their acceptance by European notified bodies is not automatic.
Step 3: appoint an EC REP authorised representative. Mandatory before any placing on the market in the EU. The appointment of the EC REP conditions access to EUDAMED and the ability to begin registering the devices.
Step 4: select a notified body and begin the certification process. For class IIa and above, contact notified bodies as soon as the classification is confirmed. Lead times are long — do not wait until the full file is ready before making contact.
Step 5: build a QMS suited to the MDR. For startups, the QMS is often non-existent or built according to FDA requirements (21 CFR Part 820) with no ISO 13485 equivalent. The migration to an ISO 13485 QMS compatible with the MDR is a structuring step.
What non-EU startups systematically underestimate
Time. A startup aiming for CE marking within 12 months for a class IIa device is working to an unrealistic timeline, unless all the conditions are already in place from the outset (complete technical documentation, clinical evaluation ready, ISO 13485-certified QMS).
Cost. The estimates of “a few tens of thousands of euros” for CE marking circulating in certain startup circles are disconnected from the reality of the MDR. For class IIa, the realistic budget is 80,000 to 150,000 euros depending on the starting point.