IMDRF guidance updates thinking on personalized medical devices

The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies have become cheaper and more ubiquitous, harmonizing regulatory oversight of PMDs may speed accessibility across jurisdictions and address the question of who takes responsibility for their safety and efficacy.

IMDRF published a guidance on 14 September 2023 on PMDs that aims to harmonize how different regulatory bodies oversee such devices and provides considerations when they may need to be addressed differently depending on the regulatory agency. While the Global Harmonization Task Force (GHTF) has produced documents on the topic in the past, IMDRF argued that technology has evolved, and those documents may be outdated now.

“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),” said IMDRF. “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.”

The guidance defines three categories of PMDs: custom-made medical devices, patient-matched medical devices, and adaptable medical devices. It provides general requirements to identify each category, and manufacturing and record-keeping requirements to ensure manufacturing consistency and that the products are trackable.

Custom-made medical devices

IMDRF members agreed that custom-made medical devices are products intended for a specific patient, are made at the request of a healthcare professional, and are meant to address the patient's specific anatomo-physiological features or pathological condition.

“Custom-made medical devices are intended to cover special cases where commercially available products or alternative therapies are inadequate for meeting the needs and requirements of particular individuals,” said IMDRF. “Many jurisdictions have addressed this challenge by implementing special regulatory pathways for custom-made medical devices, which generally includes some exemptions from the usual regulatory requirements to ensure that the specific needs of individuals are able to be met.”

For such devices, the regulatory pathway typically requires that an authorized healthcare professional provide design inputs and take some responsibility for the safety and efficacy of the final product.

"Validated computational modeling and simulation methods, including reproducing the patient-matched conditions to which the custom-made device will be exposed, may be one way to assess the safety and performance of custom-made devices. Physical testing may also be appropriate," the guidance stated. "The manufacturer should conduct a risk-analysis to determine the most appropriate methods to employ."

Patient-matched medical devices

Patient-matched medical devices are defined as products that are matched to a patient's anatomy, are typically produced in batches, and are designed and produced by the manufacturer so that they are solely responsible for their performance.

“Although design inputs, such as medical imaging or anatomic references, may be provided to the manufacturer (e.g., by an individual or authorized healthcare professional), it is the manufacturer that is responsible for matching the design of the device to the individual’s anatomy, within the design envelope, based on techniques such as scaling,” IMDRF stated in the guidance. “The manufacturer of a patient-matched medical device must ensure the device is correctly classified and must follow the usual regulatory requirements to obtain pre-market approval, according to the risk classification, in the jurisdiction in which the devices are supplied.”

Manufacturers of patient-matched medical devices also need to comply with premarket and postmarket regulatory requirements of their specific jurisdictions, which could involve conforming to clinical, safety, manufacturing, and other requirements, according to IMDRF.

Adaptable medical devices

IMDRF’s definition of adaptable medical devices is the most stringent of the three categories in terms of the manufacturer’s regulatory requirements and responsibilities. The group defines them as mass-produced products that may be “adapted, adjusted, assembled or shaped at the point-of-care.” Such devices need to meet typical premarket and postmarket requirements based on their regulatory jurisdiction, according to the group.

“In addition to the usual requirements, the manufacturer of the adaptable medical device should be required to provide validated instructions that explain how to adapt, adjust, assemble, or shape the device,” said IMDRF. “Development of the instructions should include suitable human factors considerations in order to minimize safety issues that might result from the adaptation process.”

The guidance stated that manufacturers may add certain requirements for those who end up adapting the device for personalized use, such as verification testing to keep a paper trail on how it is used. They may also require the users to undergo training before adapting the product for patients.

The guidance includes a decision tree to help manufacturers determine if their device is considered a PMD and, if so, how it is categorized. It also includes appendices that aim to answer scenario-specific questions about PMDs, such as considerations for 3D printing technology, use specific materials, and point-of-care manufacturing.

IMDRF guidance

IMDRF guidance updates thinking on personalized medical devices

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