The European Union, comprising 27 countries with a total population of nearly 450 million, is the second-largest market for medical devices globally. The introduction of the European Union Medical Devices Regulation (EU MDR) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR) marks a significant overhaul of EU medical device classification and regulation, aiming to enhance device safety and performance across the EU.
The EU medical devices market is growing steadily, driven by technological advancements, an aging population (21% 65+), and increased healthcare spending. The IVD market benefits from rising chronic disease prevalence and early diagnosis initiatives. Germany leads the region, holding 26.5% of the market share in 2023.
Medical device regulatory requirements in Europe are enforced by the Competent Authority in each Member State, while the European Commission defines the overall regulatory framework, such as the MDR and IVDR. Pure Global can assist with EU MDR and IVDR compliance and act as your EU Authorized Representative, ensuring regulatory approval to sell in the European market.
The classification under the EU MDR and IVDR is critical to determining the regulatory pathway for medical devices and IVDs, dictating the level of scrutiny and documentation required for market access.
Manufacturers must:
Our expert services simplify your entry into the EU market:
Assistance with product classification and determination of the regulatory pathway.
Support in compiling the necessary technical documentation for compliance with the EU MDR/IVDR.
Acting as your EU Authorized Representative, facilitating pre-market certification processes and managing post-market responsibilities.
The primary regulations are the EU Regulation of Medical Devices (EU MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR). These regulations aim to enhance the safety and performance of medical devices across the EU.
Medical devices and in vitro diagnostic devices (IVDs) are classified under the EU MDR and IVDR based on their risk level. The classes of medical devices in the EU determine the regulatory pathway, the level of scrutiny, and the documentation required for market access. The classification process is critical for compliance and market entry.
Foreign manufacturers must: Appoint an EU Authorized Representative (AR) to act as a liaison with European national Competent Authorities under the EU MDR. Compile comprehensive and extensive technical documentation and submit it for certification as necessary in compliance with the EU MDR. Adhere to the increased responsibilities and obligations under the EU MDR/IVDR for market activities.
Appointing an EU Authorised Representative (EUAR) is essential for foreign manufacturers because the EUAR acts as a liaison with European national Competent Authorities. The EU Authorised Representative ensures compliance with EU regulations, facilitates communication, and handles regulatory issues, enabling the manufacturer to market their medical devices in the EU.
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
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