The new article covers the matters related to classification of personalised devices and provides additional clarifications in this respect.
Table of content
ANVISA, a Brazilian regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to personalised 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.
Determining the Classification of Personalized Medical Devices
If the manufacturer is in doubt about the classification of a personalized medical device – whether it’s custom-made, patient-specific, or adaptable – they should submit an inquiry through the “Fale Conosco” (Contact Us) system.
In particular, they should fill out the form with the following information:
- Product Design Development: Describe how the product’s design was created.
- Dimensions and Adaptability: Indicate whether the dimensions have fixed intervals or can be adapted according to patient specifications.
- Exclusive Patient Design: Specify if the product design was developed exclusively for the patient in question or adapted from a base design.
- Manufacturing Process Scale: State whether the manufacturing process is performed on a commercial scale.
- Additional Information: Include any other relevant details applicable to the product.
Note: The form allows the applicant to attach supporting documents to the inquiry.
Conducting Clinical Trials After Notification
According to Article 1, sole paragraph, of RDC No. 305/2019 (revoked by RDC No. 925 on September 19, 2024), this resolution does not apply to the authorization of clinical trials. Therefore, it does not implicitly permit the use of these products for clinical research.
For conducting clinical trials, the manufacturer must submit consent requests as defined by RDC No. 548 of August 30, 2021.
Information Required in the Custom-Made Device Notification Form
According to the guidance, a manufacturer should provide a detailed description of the components it intends to manufacture, considering the product already regularized and presented as proof of their understanding of specific requirements and technological expertise. For example: If registering systems of plates and screws for osteosynthesis, mention the plates as per the reference registration provided for consent purposes.
Important Notes:
- Avoid Commercial Names and Generic Identifications: Do not use brand names or vague descriptions; instead, use precise technical terms.
- Customization Limitations: Not all medical devices are subject to customization. For instance, screws used for fixing components like osteosynthesis plates are generally not customizable.
Including New Devices in the Declaration of Responsibility
An interested party should submit a “Company Rectification” petition linked to the existing consent for manufacturing or importing custom-made medical devices.
This submission must include a new Declaration that:
- Covers the custom-made devices already approved.
- Adds the new custom-made medical devices the applicant wishes to include.
Requirements:
- Valid Registration Proof: Provide evidence of valid Anvisa registration for medical devices manufactured on a commercial scale, in the same manufacturing unit, with the same risk class and intended use as the custom-made device.
- Await Anvisa’s Decision: After submission, wait for Anvisa’s decision, which will be communicated via an electronic notice to the company’s mailbox.
Commencing Manufacture After Consent Approval
Once the applicant receives the official communication indicating a favorable decision on the consent petition to manufacture or import custom-made devices, they may:
- Submit Notifications: Provide the required information for each custom-made medical device through notifications.
- Begin Manufacturing: Proceed to manufacture the notified devices.
Important Reminders:
- Do Not Modify Annex Models: The templates provided in Annexes I and III of RDC No. 305 (revoked by RDC No. 925) must not be altered.
- No Additional Documents: Do not attach extra documents to the notification protocol when submitting notifications.
Documentation Issued for Notifications
An application number will be generated upon submission of the notification. The regulations do not stipulate any publication or issuance of official statements by Anvisa regarding these notifications.
Consolidating Multiple Devices in a Single Notification
Generally, the interested party must submit a separate manufacturing or importation notification for each custom-made device to be supplied. Therefore, if the healthcare professional prescribes both an osteosynthesis plate and a reconstruction plate simultaneously, the applicant should make two separate notifications.
Exceptions – Interdependent Devices: If the intended use of the devices is interconnected – meaning they function together as a system – the applicant may submit a single notification.
Examples:
- Temporomandibular Joint Reconstruction Plates: Typically provided in pairs (fossa component and mandibular plate), where both are necessary for the device’s functionality.
- Osteosynthesis Plates in Orthognathic Bucomaxillofacial Surgery: The success of the procedure depends on implanting the complete set of plates as a system.
Conclusion
In summary, these clarifications are intended to guide companies in understanding and complying with Anvisa’s regulatory requirements for personalized medical devices.
Key points include:
- Classification Inquiries: Use the “Fale Conosco” system to resolve doubts about device classification.
- Clinical Trials Authorization: Notifications under RDC No. 305 do not authorize clinical trials; separate consent is required.
- Notification Details: Provide precise technical descriptions in notification forms, avoiding commercial names and generic terms.
- Updating Declarations: Follow proper procedures to include new devices in a Declaration of Responsibility, ensuring all regulatory criteria are met.
- Manufacturing Timeline: Begin manufacturing only after receiving official approval and submitting necessary notifications.
- Documentation: An application number confirms the notification; no additional documents or acknowledgments will be issued by Anvisa.
- Multiple Devices Notification: Submit separate notifications for each device unless they are interdependent and function as a single system.
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