Entering the European MedTech market requires more than regulatory knowledge. Success under MDR and IVDR depends on clinical evidence strategy, QMS alignment, and early Notified Body preparation.
QbD Group supports Medical Device and IVD manufacturers across their entire EU journey. We combine regulatory, quality, and clinical expertise into a first-time-right approach, helping you move faster, reduce uncertainty, and achieve sustainable compliance.
Europe is one of the most attractive MedTech markets worldwide. It represents approximately 26% of the global market, with an estimated value of €170 billion.
A single CE mark enables access to multiple countries and healthcare systems, making Europe a powerful platform for scalable growth beyond domestic markets.
Why Europe matters for MedTech companies:
Market access across multiple EU countries with one certification
Strong demand for innovative Medical Devices and IVDs
A large, established healthcare market with long-term growth potential
A strategic next step for successful non-EU manufacturers
For non-EU companies, Europe is often the logical next step after success at home. At the same time, EU market access follows a distinct regulatory logic. MDR and IVDR place strong emphasis on clinical evidence, lifecycle responsibilities, and early alignment with Notified Bodies. Addressing these requirements early helps avoid delays and rework later on.
QbD Group supports non-EU Medical Device and IVD manufacturers with European market entry and long-term compliance.
We adapt our support to your starting point. From early development to CE marking and beyond, we define a clear European regulatory pathway, align quality and clinical activities, and keep timelines predictable.
Our focus is simple. Clarity, control, and regulatory certainty at every stage, from planning through post-market obligations.
