All Markets served
/
European Union

EU Medical Device Classification & Regulation (MDR/IVDR)

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.

$181.6b
MD Market size
4.76%
MD Market CAGR
$24.85b
IVD Market size
4.5%
IVD Market CAGR
800,000
Sector Employment
21%
Aging Population

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.

Oliver Eikenberg, PhD
Global QA/RA Manager
Device Classification and Regulatory Pathways

Adapting to the EU's New Regulatory Framework

Regulatory Authority

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.

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.

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 much does it cost to certify a medical device in 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.

How long does it take to obtain CE Marking for a medical device or IVD in the EU?

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.

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.

Single Process,
Multiple Markets

When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.

Let's Talk,
Anywhere You Are.

Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.

Contact us