The primary purpose of this IMDRF guidance is to recommend a harmonized approach for the application of existing regulatory pathways to medical devices that are intended for a particular individual, and to identify special considerations for the regulation of each identified category of personalized medical device (PMD). The adoption of consistent, harmonized requirements for such medical devices will underpin a harmonized regulatory approach for controls on these types of medical devices and offer significant benefits to the manufacturer, user, patient, and to Regulatory Authorities (RAs).

Eliminating differences between jurisdictions supports global convergence, reduces the cost of gaining regulatory compliance and allows patients and healthcare professionals earlier access to new treatments and technologies. This document includes an overview of some of the considerations and
concepts that may be relevant in developing a harmonized assessment approach in future.

Technology has progressed from the time the original Global Harmonization Task Force (GHTF) foundation documents were published. It is now possible to produce medical devices that are individualized on a commercial rather than artisanal scale. Manufacturing technologies used to create these PMDs include computer-controlled additive and subtractive manufacturing methods based on patient images. The original GHTF documentation does not adequately address medical devices of this nature.

Many jurisdictions already define the term custom-made device and have introduced exemption provisions for regulating custom-made medical devices, with the intention of covering special cases where commercially available products or alternative therapies are inadequate for the needs and requirements of a particular individual. In some jurisdictions the exemption provisions were based on the premise that affected devices would largely comprise low-risk products or limited use of higher-risk implantable devices. In other jurisdictions the exemption provisions were established with the intention that numbers of manufactured custom-made devices would necessarily be small due to the requirement for them to be used only in special cases.

Now regulators are faced with a very different environment. Technologies such as additive and subtractive manufacturing (see Appendix 1), especially when combined with digital patient data, have made “custom-made” devices, including implantable devices, within reach on a much greater scale.
Furthermore, advancing technology has also enabled a shift to near or at point-of-care manufacturing (collectively referred to as POC manufacturing throughout this document) for manufacturing a broad range of medical devices not limited to PMDs only.

Existing regulations and guidance were not necessarily designed to address this form of manufacturing and, consequently, present challenges for RAs to ensure that the medical devices produced at POC manufacturing facilities meet the same requirements of quality, safety and performance as medical
devices produced at traditional manufacturing facilities. A secondary purpose of this IMDRF guidance is to provide some considerations for how the current regulatory frameworks can be adapted to address this evolution in manufacturing practices.

Note: This document is intended to provide a best-practice model for suitable regulatory pathways for different types of medical devices and is primarily intended to assist with harmonizing the regulation of PMDs across international jurisdictions.

Individual jurisdictions may have particular requirements in place, which pre-date this guidance or that are more specific than this guidance, for some or all of the device categories represented.