EU Medical Device Classification & Regulation (MDR/IVDR)
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.
Adapting to the EU's New Regulatory Framework
Regulatory Authority
Pure Global can assist with EU MDR and IVDR, ensuring European Commission approval to sell in the European market.
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.
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.
Frequently
Asked Questions
What are the primary regulations governing medical devices in the European Union?
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.
How are medical devices classified under the EU MDR and IVDR?
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.
What are the key requirements for foreign manufacturers to market medical devices in the EU?
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.
Why is appointing an EU Authorized Representative important for foreign manufacturers?
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.
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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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.