Normative ruling on essential safety and performance requirements for medical devices enters into force
By Sotiz Rizo, André Lins and Bernadete de Figueiredo Dias
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.
In addition, product manufacturers will now have to maintain a risk management system for medical devices and IVDs throughout their life cycle, to guarantee their quality and safety; in addition to being able to identify known and foreseeable risks and estimate and evaluate the risks associated with and arising from intended use and reasonably foreseeable misuse, adopting measures to eliminate and control these risks if necessary.
Among the innovations brought in by the Resolution, two important points stand out:
Clinical assessment
As opposed to the previous RDC No. 546/2021, which only generically established the need to compile scientific literature to demonstrate the adequacy of clinical data on the use of the health product, the Resolution determines the need to obtain scientifically valid clinical data, to support the indication and purpose of use, the performance, and the safety of a medical device.
This assessment must be able to prove the existence of a favorable risk-benefit ratio of the medical device or IVD, by presenting one or more of the following documents: (i) clinical evaluation report, containing a critical analysis of relevant scientific literature, in which the results present an acceptable level of evidence in the hierarchy used by evidence-based medicine; and (ii) clinical investigation report, and for IVDs, the clinical performance evaluation report must be presented.
It is worth mentioning that the clinical assessment report must be updated periodically by the manufacturer, considering the existence of significant risks, and when there are substantial changes capable of impacting the performance and/or safety of the device.
Use of medical devices and IVDs by lay people
In an innovative way, the Resolution regulates the use of medical devices and IVDs by lay users, with the aim of preventing the occurrence of risks associated with this form of use.
Manufacturers must therefore provide information and instructions that are easy for lay people to understand and apply when using the medical device or IVD and interpreting the results. Nevertheless, they must be designed and manufactured in such a way as to ensure that the medical device and IVD can be used safely and accurately by the user; as well as to adequately reduce the risk of error on the part of the lay user when handling the medical device or IVD and, if applicable, when interpreting the results.
Furthermore, if medical devices and IVDs are intended for use by lay people, methods must be included by which they can verify, at the time of use, that the medical device or IVD performs as intended by the manufacturer, and be warned if the medical device or IVD does not work as intended or does not provide an appropriate result.
The Resolution is the result of debates held at the International Medical Devices Regulators Forum (IMDRF), and reflects ANVISA’s commitment to international regulatory convergence, and to the member countries of the Southern Common Market (Mercosur).
Our Life Sciences team is available to assist you with the matter and to provide any clarification your company may need.
This bulletin is for information purposes only and should not be relied upon to obtain legal advice on any of the topics dealt with here. For additional information, please contact the leaders of the Life Sciences team.
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