EU medical device registration requirements are governed by the Medical Device Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR). Low-risk Class I devices may follow a self-certification route, while most devices require Notified Body involvement, formal certification, and full technical documentation review to obtain CE Marking.
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 MDR and IVDR marks a significant overhaul of EU medical device classification and regulation, aiming to enhance device safety and performance across the EU.
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.
The cost of entry to the European market will largely depend on risk classification, the fee for conformity assessment activities carried out by notified bodies (NBs), and whether clinical investigations are necessary. Foreign manufacturers will also need to consider representation fees. For regulatory support and depending on the level of assistance needed, manufacturers can expect anywhere from €4000 to €50,000 or more. This does not include any performance testing and certification costs.
The official timelines for market access will vary greatly between low-risk and high-risk devices. Devices that require NB involvement need to consider review timelines for conformity assessment. Manufacturers can expect anywhere from 6–36 months depending on the quality of the application. This timeline does not consider clinical investigations or additional performance testing.
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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