Medical Device Regulation for Custom-made Devices

Defining Custom-Made Medical Devices

Before diving into regulations, it’s essential to understand what custom-made medical devices denote.

A ‘custom-made device’ is defined as any device that:

• Is intended solely for the use of a particular individual (which could be a patient or healthcare professional);
• Is created based on a written request from an authorized healthcare professional, who takes responsibility for providing specific design characteristics even though the design may be developed in consultation with a manufacturer
• Is designed to cater to the distinct anatomical, physiological, or pathological attributes of the individual for whom it is intended.

However, mass-produced devices that are adapted to fit the specific needs of any professional user, as well as devices mass-produced through industrial manufacturing methods following written prescriptions from any authorized individual, do not fall under the category of custom-made devices.

Some of the examples includes:

• An orthosis made in accordance with a written prescription containing specific design characteristics to aid a person with neuromuscular or musculoskeletal impairment of the lower extremity, such as a Knee Ankle Foot Orthosis (KAFO).
• Hand prosthesis intended to replace a lost body part and/or function made in accordance with a written prescription, where the partitioner provides patient specific design characteristics necessary for the manufacturing of the device.

Regulatory Framework

Custom-made medical devices are subjected to regulatory oversight to ensure patient safety and product quality. The regulations governing these devices typically fall under the broader umbrella of Medical Device Regulations (MDR). However, due to their unique nature, custom-made devices often have distinct regulatory requirements.

To clarify the regulatory requirements for these devices, the Medical Device Coordination Group (MDCG) and the International Medical Device Regulators Forum (IMDRF) prepared the following guidance documents in March 2020 and March 2021, respectively:

• The IMDRF wrote the “Personalized Medical Devices – Regulatory Pathways
• The MDCG wrote the “MDC 2021-3 Questions and Answers on Custom-Made Devices

In the European Union (EU), custom-made medical devices are regulated under the Medical Devices Regulation (MDR). As per Medical Device Regulation 2017/245, Custom-made devices are tailored to the specific requirements of an individual patient and are exempt from certain regulatory requirements. Also, manufacturers of custom-made devices may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing.

Procedure for custom made devices as per Annex XII of EU MDR

What is NOT needed?

Custom made medical devices are exempted from the requirements of the following –

• Technical Documentation including clinical evaluation, custom-made devices.
• Unique Device Identification (UDI) system.
• Summary of safety and clinical performance.
• EU Declaration of Conformity.
• Registration within the European Database on Medical Devices (EUDAMED).

Additionally, custom-made devices are not eligible for the CE mark, indicating that they have not undergone the standard conformity assessment procedures applicable to mass-produced devices.

*NOTE – There is no custom-made In-Vitro Diagnostic Devices permitted as per IVDR 2017/746

Additional specifics for class III custom-made implantable

High-risk custom-made medical devices require special attention and are a primary concern for the regulators. In order to address these risks, an additional requirement is imposed on Class III custom-made implantable devices, namely regarding conformity assessment.

In addition to adhering to the specifications detailed in Annex XIII, manufacturers must also undergo a conformity assessment as specified in Chapter I of Annex IX. The two main pathways for this assessment are either by adhering to the guidelines set forth in Annex IX, Chapter I, or by following Annex XI, Part A.

Furthermore, as per Annex XII of EU MDR, the statement referred to in the steps 6 of the ‘Procedure for custom made devices’ shall be retained for a period of at least 15 years

Conclusion

The goal of regulations pertaining to custom-made medical devices is to strike a balance between innovation and patient safety. By understanding and complying with these regulations, manufacturers can continue to develop innovative solutions tailored to individual patient needs, while healthcare professionals can confidently prescribe and utilize these devices to improve patient outcomes. Ultimately, a collaborative effort between regulators, manufacturers, healthcare professionals, and patients is essential to ensure the safe and effective use of custom-made medical devices in modern healthcare practice.

Reference

1. Medical Device Regulation (EU) 2017/745 of the European Parliament And Of The Council

2. IMDRF Final Document Personalized Medical Devices – Regulatory Pathways

3. MDCG 2021-3 Guideline: Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices

4. https://qbdgroup.com/en/blog/the-regulatory-pathway-for-your-custom-made-medical-device/

5. https://www.i3cglobal.com/custom-made-medical-devices/

Author – Diksha Dey