The new article describes in detail different types of personalised medical devices and highlights the key points.
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ANVISA, a Brazilian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to personalized medical devices. Structured as a questions-and-answers document, the guidance outlines the key points to be taken into consideration by medical device manufacturers and other parties involved and also provides additional clarifications and recommendations.
At the same time, it is important to mention that provisions of the guidance and recommendations provided therein could be subject to changes, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
The scope of the guidance covers, inter alia, the aspects related to different types of personalised medical devices. However, it is important to emphasize that the devices mentioned below are merely illustrative, and their classification by the manufacturer must consider the definitions of personalized medical devices outlined in RDC No. 305 of September 24, 2019, which was revoked by RDC No. 925 of September 19, 2024.
1. Custom-Made Medical Devices
According to Article 2, Item III, a Custom-Made Medical Device is exclusively intended for use by a particular individual. It is specifically manufactured according to a prescription from a qualified healthcare professional, who provides specific design characteristics under their responsibility, even if the design can be developed in conjunction with the manufacturer.
In this context, as stipulated in RDC No. 305/2019 (revoked by RDC No. 925/2024), and in compliance with Article 10, the manufacturer or importer must have prior consent (primary petition) and notify the manufacturing or importation before the act of manufacturing/importing (secondary petition). Any device that does not meet the manufacturer’s basic design and, therefore, cannot be resized, is considered a Custom-Made Medical Device.
Examples of such devices would include:
- Plates Used in Cranioplasty Procedures: Plates tailored to the specific requirements of the prescribing healthcare professional and other technical information applicable to this type of medical device.
- Plates for General Bone Reconstruction: Includes bucomaxillofacial and orthopedic reconstructions/fixations where the contours and dimensions of the bone defect to be compensated are not reasonably predictable. In other words, when it’s not feasible to obtain the implant by resizing from a base design.
- Plates for Bone Fixation Procedures: Plates whose models, trajectories, and fixation methods are specifically proposed by the professional responsible for the patient.
- Femoral Acetabular Components: Manufactured considering the need to adjust the acetabular surface due to the patient’s bone loss and other technical information provided by the prescribing healthcare professional.
- Temporomandibular Arthroplasty Systems: Systems manufactured to meet the requirements of the prescribing professional and not provided for in the manufacturer’s base design.
2. Patient-Specific Medical Devices
As per Article 2, Item IV, a Patient-Specific Medical Device is a device that is made compatible with a patient’s anatomy using sizing techniques based on anatomical references or using anatomical characteristics obtained from imaging exams. It is typically produced in batches through a process that can be validated and reproduced under the manufacturer’s responsibility, even if the design can be developed in collaboration with the qualified healthcare professional.
Examples are:
- Temporomandibular Arthroplasty Systems from Base Design: Manufactured from the manufacturer’s base design, where there is a need to resize components to suit the patient’s anatomy.
- Non-Conventional Endoprostheses for Limb Reconstruction: Devices designed to replace or support a limb, customized based on patient-specific anatomical data but derived from an existing design.
- Cardiovascular Endoprostheses Adapted from Existing Designs: Manufactured from an existing project but adjusted to the anatomical specificities evidenced by imaging techniques.
- Surgical Guides: Tools created based on patient imaging to guide surgical instruments accurately during procedures.
3. Adaptable Medical Devices
Following Article 2, Item V, an Adaptable Medical Device is a mass-produced medical device that must be adapted, adjusted, assembled, or molded according to the manufacturer’s validated instructions at the point of care. This is done to suit the specific anatomical and physiological characteristics of a patient before use.
Examples:
- Meshes Used in Fracture Reconstruction and Reduction: Meshes whose dimensions are altered by the healthcare professional in the surgical center to fit the patient’s specific needs.
- Bone Cements for Craniofacial Defect Repair: Used in repairing bone defects such as fabricating cranial vaults, where the material is shaped during the procedure.
- Osteosynthesis Systems Requiring Molding: Systems where plates and/or rods need to be molded to adjust to the curvature of the region that will receive the implant.
- Polymeric Implants for Osteosynthesis: Implants that need to be thermo-molded at the time of the surgical procedure to fit the patient’s anatomy.
- Meshes for Abdominal Hernia Treatment: Meshes that can be resized during the surgical procedure for better accommodation and support of the tissue where they will be implanted.
Conclusion
In summary, understanding the different categories of personalized medical devices is crucial for compliance with regulatory standards and ensuring patient safety. Manufacturers and healthcare professionals must carefully classify devices based on the definitions provided in the relevant regulations (RDC No. 305/2019 and RDC No. 925/2024).
Custom-Made Medical Devices are exclusively designed and manufactured for an individual patient based on a specific prescription and cannot be obtained by resizing a base design.
Patient-Specific Medical Devices are adapted to a patient’s anatomy using validated processes and existing designs, produced under the manufacturer’s responsibility.
Adaptable Medical Devices are mass-produced but require adaptation or molding at the point of care to fit the patient’s unique anatomical and physiological characteristics.
Thus, by adhering to these definitions and following the appropriate regulatory procedures, including obtaining prior consent and providing necessary notifications, stakeholders can ensure that personalized medical devices are safely and effectively integrated into patient care.
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