Europe

As a medtech manufacturer, you know that gaining access to the European market under MDR (for medical devices) or IVDR (for in vitro diagnostics) is more complex than ever. These regulations demand significantly more clinical evidence, traceability, post-market surveillance, and technical documentation, while requiring coordination with Notified Bodies for higher-risk devices. After CE certification is achieved more and more individual countries within EU do have registration requirements before you can enter that market. For non-EU manufacturers, an EU Authorized Representative is legally required to ensure compliance and act as the main point of contact with EU authorities. The high regulatory expectations and limited Notified Body capacity make timely market access a significant operational hurdle for medtech companies. You do not want to have your businessplanning interrupted or delayed because the regulatory pathway for CE marking is not aligned.

At Qserve, the EU regulations are the core of our business. Having management and consultants that originate from Notified Bodies, we understand how to navigate the process for CE certification and can support you with all steps during the process. Important part is the contact with your Notified Body, it is a long process and need a proper plan. We are experts, guiding you through the labyrinth of requirements, rules, guidances and regulatory scrutiny. We provide strategic support for classification, documentation, and conformity assessment, while acting as your EU Authorized Representative if needed. From market planning to technical execution, we guide you every step of the way to ensure efficient access, long-term compliance, and minimized risk in the EU.