The new article highlights certain specific aspects related to the regulatory status of personalised devices allowed for marketing and use in Brazil.
Table of content
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.
Regularization of Patient-Specific Medical Devices with Anvisa
Article 3 of RDC No. 305, dated September 24, 2019, establishes that patient-specific medical devices are subject to regularization with Anvisa, according to the criteria set forth in RDC No. 751, dated September 15, 2022, and other current regulations. How should these products be regularized with Anvisa? Should it be by size ranges?
According to the guidance, the applicable instructions for regularizing these products should be determined according to their risk class.
For Risk Classes III and IV
Until the implementation of RDC No. 305 on September 24, 2019, patient-specific medical devices of risk classes III and IV were treated the same as custom-made medical devices. This meant they were analyzed and authorized on a case-by-case basis.
From the effective date of RDC No. 305, which was revoked by RDC No. 925 on September 19, 2024, these products must be regularized with Anvisa through a registration petition. This process must comply with the requirements of RDC No. 751 (September 15, 2022) and RDC No. 546 (August 30, 2021), among other applicable regulations.
Specifications Required:
- Specify Possible Variations: According to the type of medical device, including dimensional data applicable to the device.
- Inform Dimensional Ranges: Provide all dimensional ranges applied to each of the axes.
- Include Device-Specific Data: Thicknesses, angles, holes (position and quantity), and other intrinsic data relevant to each type of medical device according to its nature (cardiac, digestive, neurological, dental, ophthalmological, orthopedic, otorhinolaryngological, pulmonary, urological, and vascular).
Regularization with Standard Devices
Notably, if patient-specific medical devices originate from a base design and are subject to adjustments due to anatomical specificities (as defined in Article 2, Item IV of RDC No. 305, dated September 24, 2019, revoked by RDC No. 925, dated September 19, 2024), they may be regularized together with the standard medical device from which they result. In such cases, a separate regularization process is not necessary.
In order to demonstrate the safety and effectiveness, manufacturers should:
- Define Critical Components: Identify the most critical components for performing tests applicable to the product’s performance evaluation.
- Conduct Critical Analysis: Ensure the analysis of results is critically constructed and aligned with the Risk Management performed exclusively for this product segment during the design stage.
- Prepare Essential Reports: Consider patient-specific medical devices in the Clinical Evaluation Report, Biocompatibility Report, and other project documents that comprise the Master Project Record (MPR).
For Risk Classes I and II
Patient-specific medical devices of risk classes I and II must be regularized with Anvisa through the notification protocol, adhering to the requirements of RDC No. 751 (September 15, 2022) and RDC No. 546 (August 30, 2021), among others.
The requesting company should:
- Specify Dimensional Variations: Detail the possible dimensional variations applicable to the device.
- Inform Dimensional Ranges: Provide all dimensional ranges applied to each of the axes.
Application of Grouping Requirements
As established in Article 3 of RDC No. 305 (September 24, 2019), revoked by RDC No. 925 (September 19, 2024), the regularization of these medical devices must be carried out according to the criteria established in RDC No. 751 (September 15, 2022) and other current regulations.
For implantable medical devices in orthopedics, the grouping requirements provided in RDC No. 594 (December 28, 2021) must be met.
This includes:
- Family Grouping: Devices with similar characteristics grouped under a single registration.
- System and Set Grouping: Classification based on functionality and intended use, as stipulated in current regulations.
Requesting Manufacture or Importation of Custom-Made Medical Devices
The request for manufacture or importation of custom-made devices must be made only for medical devices in risk classes III and IV.
According to the guidance, the submission process to be followed includes:
- Electronic Petitioning System: Use the online protocol for submitting the petition for consent to manufacture or import custom-made medical devices.
- Required Information: Include the details recommended in Article 9 of RDC No. 305 (September 24, 2019), revoked by RDC No. 925 (September 19, 2024).
- Manufacturing Unit Specificity: This petition must be submitted for each manufacturing unit.
The scope of Anvisa’s analysis will cover the following aspects:
- Technical Evaluation: The competent technical area will analyze the petition to verify if the company meets the criteria to manufacture and/or import custom-made medical devices.
- Await Approval: The company must wait for Anvisa’s conclusion and decision regarding consent.
- Communication of Decision: Anvisa’s decision will be published and communicated to the company via electronic notice.
Post-Consent Procedures
Notification for each patient and device after consent is granted includes:
- Submit Notification Petition: For each patient and each custom-made medical device, the company must submit a notification petition for the manufacture or importation.
- Linked Petitions: This petition should be linked to the initial consent petition.
- Information Requirements: Notifications must contain the information recommended in Article 10 of RDC No. 305 (September 24, 2019), revoked by RDC No. 925 (September 19, 2024).
- Implementation Without Prior Approval: These notifications do not require prior approval from Anvisa to be implemented.
Anvisa’s Right to Request Additional Information
As per Article 19: Anvisa may, at any time, require the manufacturer/importer to provide additional documents and information regarding the medical devices covered by this Resolution.
Different Manufacturing Units
In cases where the company will manufacture or import a custom-made device from a manufacturing unit different from that specified in the primary consent petition:
- Submit New Consent Petition: The company must first petition for new consent specific to this new manufacturing unit.
- Subsequent Notifications: After obtaining consent, the company must submit notification petitions linked to this new process for other products manufactured at this new unit.
Conclusion
In summary, the regularization of patient-specific and custom-made medical devices with Anvisa requires careful adherence to the regulatory framework established by various Resolutions (RDCs).
Key points include:
- Risk Class Determination: The process varies depending on whether the device is classified under risk classes I and II or III and IV.
- Detailed Specifications: Companies must provide comprehensive details about device variations, dimensions, and intrinsic characteristics.
- Compliance with Grouping Requirements: Devices must be grouped according to current regulations, facilitating streamlined registration processes.
- Manufacture and Importation Requests: Specific procedures must be followed for obtaining consent, especially for custom-made devices in higher risk classes.
- Anvisa’s Oversight: Anvisa maintains the authority to request additional information and ensure compliance at all stages.
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