New guidance on regulatory pathways for personalized medical devices

International Medical Devices Regulators Forum releases final guidance document

The International Medical Device Regulators Forum (IMDRF) is a  voluntary group of medical device regulators from around the world.  They have recently issued a final guidance document - Personalized Medical Devices – Regulatory Pathways.  The purpose of the guidance is to:

• recommend a harmonized approach for the application of existing regulatory requirements for medical devices that are intended for a particular individual; and,
• identify special considerations for the regulation of identified categories of personalized medical device.

This guidance also provides an overview of considerations and concepts that could be relevant in developing a harmonised assessment approach in future.

Many jurisdictions define the term custom-made device. Custom-made devices are intended:

• for the sole use of a particular individual; and,
• to be made in accordance with a written request of an authorized healthcare professional; and,
• to address specific anatomo-physiological features or pathological condition of the individual for whom it is intended.

The regulatory requirements have introduced exemptions for regulating custom-made medical devices in order to cover situations where commercially available devices are inadequate for the needs and requirements of a particular individual.  These exemptions have been based on premises that affected devices would:

• be used only in special cases and so the numbers of manufactured custom-made devices would be low; and,
• largely comprise low-risk products or limited use of higher-risk implantable devices.

However, technological development has meant that it is now possible to manufacture individualized medical devices in a completely different manner from the skilled, manual processes that were originally envisaged. Computer-controlled additive and subtractive manufacturing methods (often called 3-D printing) can be used to create personalized medical devices based on digital patient data, potentially with the manufacturing activity undertaken at the point-of-care. Growing numbers of patients are receiving these medical devices to meet their particular needs.

This recent guidance builds on a previous IMDRF document Definitions for Personalized Medical Devices. As well as custom-made medical device, the additional terms patient-matched and ‘adaptable’ medical device are introduced. These devices are designed and produced under the responsibility of a manufacturer, where:

• adaptable medical devices are mass-produced and adapted, shaped or assembled at the point-of care in accordance with specific patient’s specific anatomo-physiologic features following the manufacturer’s instructions; whereas,
• patient-matched medical devices are scaled within a specified design window using anatomic references or anatomical features from patient imaging.

The guidance document gives a flowchart describing how to classify a device into these three categories of personalized medical devices. It provides recommendations for custom-made, patient-matched and adaptable medical devices. Two annexes provide considerations for personalized devices:

• produced using additive or subtractive manufacturing; and,
• manufactured at point-of care.

This guidance will be relevant to manufacturers producing personalized medical devices or looking into additive or subtractive manufacturing technology or point-of-care manufacturing.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development