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Regulatory Landscape for Custom-Made Medical Devices in the EU

Updated: Jun 19, 2023

Custom Made Medical Devices in the EU. What a Custom Made is?

Custom Made Medical Devices in the EU plays a crucial role in meeting the unique needs of patients, providing personalized solutions for improved healthcare outcomes. However, the regulatory landscape for custom-made devices in the European Union (EU) presents specific challenges and considerations. In this blog post, we delve into the intricacies of developing and navigating the regulatory requirements for custom-made medical devices in the EU.

Steps for Custom made in the EU

1. Understanding Custom-Made Medical Devices:

Custom-made medical devices are designed, manufactured, and adapted to meet the specific requirements of individual patients. These devices are tailor-made based on patient-specific characteristics, such as anatomy, pathology, or physiological conditions. Custom-made devices can range from prosthetics and orthotics to dental implants and surgical instruments.

2. Regulatory Framework:

The EU regulatory framework for custom-made medical devices is governed by the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The regulations recognize the unique nature of these devices and provide specific provisions to ensure patient safety while accommodating customization.

3. Definition and Scope:

The MDR defines custom-made devices as those "manufactured specifically in accordance with a written prescription from a qualified healthcare professional." The scope includes devices that are individually manufactured or adapted based on specific characteristics of an individual patient.

4. Regulatory Requirements:

Developing and placing custom-made devices on the market requires adherence to specific regulatory requirements. These may include the involvement of qualified healthcare professionals, appropriate documentation, conformity assessment, traceability, and post-market surveillance. Compliance with essential safety and performance requirements is essential to ensure patient safety.

5. Notified Body Involvement:

Notified bodies play a vital role in the conformity assessment of custom-made devices. They assess the manufacturer's processes, quality management system, and technical documentation to ensure compliance with regulatory requirements. Notified bodies also verify that devices are manufactured in accordance with the prescription provided by qualified healthcare professionals. However, they are only requested for class III devices.

6. Risk Management and Post-Market Surveillance:

Managing and mitigating risks associated with custom-made devices is crucial. Manufacturers must establish robust risk management processes to identify and address potential hazards. Additionally, post-market surveillance plays a vital role in monitoring device performance, gathering feedback, and identifying any adverse events or issues that may arise.

7. Collaboration and Expertise:

Developing custom-made devices requires close collaboration between manufacturers, healthcare professionals, and regulatory experts. Engaging with knowledgeable consultants and experts in the field can help manufacturers navigate the regulatory landscape, ensuring compliance and successful market entry.


The development and regulatory compliance of custom-made medical devices in the EU require a thorough understanding of the unique challenges and specific provisions outlined in the MDR and IVDR. By following the regulatory requirements, collaborating with qualified healthcare professionals, and engaging with experienced regulatory partners, manufacturers can navigate the landscape successfully. Custom-made devices, when developed and regulated with patient safety as the top priority, have the potential to revolutionize personalized healthcare and improve patient outcomes in the EU.

AF Pharma is dedicated to being your trusted partner in achieving compliance, registering, and successfully selling your medical devices in the EU market. With our deep knowledge of EU regulations, expertise in quality management systems, and comprehensive support services, we guide you through the complex process, minimizing complexities and ensuring a smooth path to market entry. Trust AF Pharma to help you navigate the EU regulatory landscape and unlock the potential for growth and success in the EU market. Contact us today to discuss how we can assist you in achieving EU compliance and market success.

Custom-Made Medical Devices in the EU
Custom-Made Medical Devices in the EU

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