Normative ruling on essential safety and performance requirements for medical devices enters into force

Lexology October 10, 2024
CGM Advogados

On September 4, 2024, RDC No. 848/2024 (“Resolution”) of the National Health Surveillance Agency (“ANVISA”) came into force, replacing the previous RDC No. 546/2021, which updated the rules on the essential safety and performance requirements applicable to medical devices, including in vitro diagnostic (IVD) medical devices.

The Resolution provides, more clearly and specifically, that medical devices and IVDs must meet the following requirements: (i) achieve the performance intended by the manufacturer; (ii) be designed and manufactured to be fit for purpose, under the established conditions of use; (iii) be safe; (iv) function as intended; (v) have acceptable risks compared to the benefits for the patient; and (vi) not compromise the clinical condition or safety of patients or other individuals.

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