Customized Medical Devices #01

Personalized Medicine is a reality. Today, it is possible to design medical devices, including implants, according to the anatomy of each patient, based on imaging tests. This makes it possible to create a range of solutions that were not possible before, such as:

a) cranioplasty plates that maintain the patient's cranial symmetry, causing a superior aesthetic effect;

b) knee prostheses that follow the anatomy of the patient's condyle, leading to maintenance of the natural curvature of the condyle and providing a better biomechanical sensation to the patient;

c) guides for surgical procedures, where cut or incision regions can be defined and pointed according to the patient's internal anatomy, generating more assertive and less invasive surgeries.

ANVISA has one of the most modern legislation in the world when it comes to customized medical devices such as these. RDC 305/2019, published by ANVISA in September 2019, establishes the rules for registering personalized medical devices. In general, the resolution establishes that the evaluation of a personalized product is not very different from the evaluation of an “off-the-shelf” product. Only, some additional rules, mainly in terms of traceability and safety and efficacy assessment, apply.

Naturally, traceability is a concern. The off-the-shelf products, being the same as each other, can be freely exchanged with each other during manufacturing, packaging, shipping and logistics. Personalized products have a fixed destination: a specific patient. An exchange during the production process or during logistics can have serious consequences.

Special attention to the proof of safety and efficacy is also relevant. Companies are used to testing and evaluating products with pre-established design. For a personalized product, which each patient can take on a shape, how can we guarantee that the final result will always be safe and effective?

How did ANVISA address these and other topics in RDC 305/2019 and how to adapt to them? In PART 02 of this series we will give more details!

MSC MED has experience in custom/customized medical device registration with ANVISA. If you need guidance, count on us.