Regulatory Open Forum

 View Only

  • 1.  GSPR Procedure for the MDR?

    Posted 26-Feb-2020 05:28
    Hi All. 

    I was wondering whether people have produced a specific procedure to meet the requirements of General Safety Performance Requirments  under the MDR or have you just produced a checklist to demonstrate compliance when submitting the Tech File.

    Thanks
    James

    ------------------------------
    James
    Head of QARA
    UK
    ------------------------------


  • 2.  RE: GSPR Procedure for the MDR?

    Posted 27-Feb-2020 03:57
    Hi James,

    There is no clear requirement in the MDR on how to address the GSPR.
    The checklist is usually the most effective way, because you can easily detect if you addressed every point and also for the assessor to have a rounded view of your documentation and of the solutions you adopted to meet the requirements.
    I do not think that this will change with MDR. It is quite convenient for everyone.

    Hope that helps

    ------------------------------
    Spyros Drivelos
    Medical Devices Expert, RAC
    Agia Paraskevi, Athens
    Greece
    ------------------------------

    Original Message


  • 3.  RE: GSPR Procedure for the MDR?

    Posted 27-Feb-2020 10:51
    Hi James,

    We are including GSPR in the procedure managing all of technical documentation.  Because this is a fairly straightforward document, we are just describing in the "Technical Documentation Management" procedure.  We detail how it is generated, what needs to be completed in each of the columns/rows, and reference to our template being used.  Also we are getting away from calling a "checklist" because now it is much more.  We refer to as the GSPR Matrix or GSPR Compliance Summary.  Our template being used is still the tabular structure with each requirement in a row and the different columns how we are showing compliance.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


  • 4.  RE: GSPR Procedure for the MDR?

    Posted 28-Feb-2020 06:36
    Hi Richard

    I really like that - "GSPR Compliance Summary".

    I guess the "checklist" comes from the time when you ticked off the Essential Requirements without providing any evidence.

    ------------------------------
    Richard Jansky
    Wattwil
    Switzerland
    ------------------------------

    Original Message


  • 5.  RE: GSPR Procedure for the MDR?

    Posted 28-Feb-2020 14:02
    Yep exactly Richard - thus why we - and me personally - have removed the word "checklist" from my vocabulary, documents, procedures, templates, etc. because there is much more involved with GSPR now.  I would even argue calling it the GSPR Trace/Traceability Matrix because most likely how it is going to be used now.

    ------------------------------
    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


Related Content