What is the actual budget for EU MDR compliance for medical device companies?

Since its entry into force, the European Medical Device Regulation (EU MDR) has been disrupting the healthcare sector. This regulation imposes much stricter requirements in terms of certification, clinical data, and traceability.

But the question that most worries manufacturers, especially small and medium-sized enterprises (SMEs), is simple:

👉 How much does EU MDR compliance actually cost as a percentage of turnover?

Cost of EU MDR as a percentage of turnover

Current Survey and Estimates

The available data reveals a clear trend:

• 48 % of manufacturers estimate that compliance will cost them more than 5% of their annual turnover.

• 32 % of companies believe this burden will reach at least 8% of their turnover generated in the EU.

• For some SMEs, the cost can even rise to between 8% and 15% of revenues related to certified devices.

Concrete example

For a company generating €100,000 in revenue, the budget allocated to MDR will range between €5,000 and €15,000, or even more depending on the complexity of the products. This financial burden can become overwhelming for smaller organizations.

The cost of EU MDR represents an essential strategic investment. Although the expense can reach 15% of annual revenue, this compliance is essential to remain competitive, protect patient health, and guarantee access to the European market.

Companies, particularly SMEs, must anticipate, plan, and adapt today to turn this constraint into an opportunity for growth and consolidation.