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European Union

Streamlining Compliance with EU Medical Device Regulations

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 the regulatory landscape, aiming to enhance device safety and performance across the EU.

Device Classification and Regulatory Pathways

Adapting to the EU's New Regulatory Framework

Regulatory Authority

The European Commission oversees the implementation and enforcement of the EU MDR and IVDR. These changes address past deficiencies and establish stringent requirements for medical devices and IVDs. These regulations emphasize the need for improved transparency, traceability, and accountability within the EU's medical device market. Foreign manufacturers must appoint an EU Authorized Representative (AR) to navigate this complex regulatory environment.

Classification

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.

Key Requirements

Manufacturers must:

  • Appoint an EU Authorized Representative (AR) to act as a liaison with European national Competent Authorities. Only for foreign manufacturers.
  • Compile comprehensive and extensive technical documentation and submit it for certification as necessary.
  • Ensure adherence to the increased responsibilities and obligations under the MDR/IVDR for market activities.
How We Can Help

Tailored Support for Market Entry

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.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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