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  • 1.  Brasil Resolution RDC 848/2024_Essential Requirements

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2024 09:12
    This message was posted by a user wishing to remain anonymous

    Hello RAPS Community, 

    The Resolution RDC No. 848 aims to align the regulations with advancements in the medical device sector and was published on 6. March 2024 to update the Essential Safety and Performance Requirements and revoke RDC No. 546/2021. 

    With the RDS No. 848 The Essential Safety and Performance Requirements are also now harmonized with the International Medical Device Regulator Forum (IMDRF) guidance, IMDRF/GRRP WG/N47FINAL: 2018 - Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices. ( https://www.imdrf.org/sites/default/files/docs/imdrf/final/technical/imdrf-tech-181031-grrp-essential-principles-n47.pdf) 

    What I would liketo ask for is, if we are manufacture products according to  European MDD and MDR , should we consider the requirements from IMDR Guidance? Does anyone know if those requiremnts correspond to the MDD and MDR requirements?  If no, we need probably to create a new list covering the requirements of IMDR?

    Thanks a lot for your help! 



  • 2.  RE: Brasil Resolution RDC 848/2024_Essential Requirements

    Posted 17-Apr-2024 01:54

    Dear Anon

    IMDRF Essential Principles is not applied either under the MDD or MDR. The MDR Annex I General Safety and Performance Requirements needs to be addressed; similar with MDD CE certified devices, which also had to address Annex I of MDD.

    Of course, you will find similarities in the text of the MDD/ MDR and IMDRF Essential Priniciples and Guidances. In terms of the vigilance reporting in the EU, the IMDRF coding has been adopted. As well, ISO 13485 as the quality management standard for medical devices is applied in the EU and IMDRF member countries (MDSAP uses ISO 13485).   

    Maybe you saw the recent RAPS Posting: Anvisa No. 290/2024

    «Medical devices authorized for markets regulated by four Equivalent Foreign Regulatory Authorities (Australia, Canada, USA and Japan) may have their analyzes shortened based on the manifestation of the requesting companies."

    https://connect.raps.org/discussion/anvisa-published-today-normative-instruction-no-2902024-which-establishes-the-optimized-procedure-for-the-purposes-of-analyzing-and-deciding-petitions-for-registration-of-medical-devices



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    Stephanie Grassmann
    Founder & Managing Director of MedTechXperts Ltd
    Biberstein
    Switzerland
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